Aav-delivered antibodies and methods of use thereof

Abstract

The present disclosure provides AAV-delivered antibody compositions and kits for treating and / or preventing infectious diseases (for example, Human Immunodeficiency Virus (HIV)) and methods of use thereof.

Description

[0001]Docket No.11348-047WO1 AAV-DELIVERED ANTIBODIES AND METHODS OF USE THEREOF CROSS-REFERENCE TO RELATED APPLICATION This PCT application claims priority to, and the benefit of, U.S. Provisional Patent Application No.63 / 515,218, filed July 24, 2023, which is incorporated by reference herein in its entirety. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH This invention was made with Government Support under Grant Nos. U19 AI 149646, DA052841, and AI172727 awarded by the National Institutes of Health. The Government has certain rights in the invention. REFERENCE TO SEQUENCE LISTING The sequence listing submitted on July 24, 2024, as an .XML file entitled “11348- 047WO1_ST26” created on July 22, 2024, and having a file size of 62,778 bytes is hereby incorporated by reference pursuant to 37 C.F.R. § 1.52(e)(5). FIELD The present disclosure provides AAV-delivered antibody compositions and kits for treating and / or preventing infectious diseases (such as, for example Human Immunodeficiency Virus (HIV)) and methods of use thereof. BACKGROUND Antibody-based strategies for the treatment and / or prevention of Human Immunodeficiency Virus (HIV) have been made possible by an incredible array of monoclonal antibodies with potent neutralizing activity against a broad range of HIV isolates. While such antibodies can be administered passively, repeated expensive administrations over a prolonged period would be required for extended prevention or treatment efforts. Adeno-associated virus (AAV) vectors have a number of attractive features for prolonged delivery of such antibodies. The only protein product from such AAV vectors comes from the DNA sequences put into the vector. As long as those protein products are not viewed as foreign, very prolonged delivery can be achieved. Muscle cells essentially do not turn over and intramuscular delivery of AAV vector can result in very prolonged expression of the transgene product. However, this result is Docket No.11348-047WO1 successful for a small fraction of subjects receiving AAV vector making potent broadly neutralizing anti-HIV monoclonal antibodies, known to be highly divergent from germ line. The remainder of subjects experience an anti-drug antibody (ADA) response that negates the successful delivery of the monoclonal antibody. Thus, current antibody-based strategies remain deficient in treating HIV due to intolerant immune responses to the delivered monoclonal antibodies. Given limitations of current HIV antibody-based treatment strategies, there is need to address the aforementioned problems mentioned above by developing a treatment strategy to suppress the ADA response and successfully deliver monoclonal antibodies for a very prolonged period for the treatment or prevention of HIV infection. The methods disclosed herein address these and other needs. SUMMARY The present disclosure provides methods and kit for the consistent and long-term delivery of antibodies and antibody-like molecules for the treatment and / or prevention of an infectious disease including, but not limited to human immunodeficiency virus (HIV). In one aspect, disclosed herein is method of treating or preventing a human immunodeficiency virus (HIV), a hepatitis B virus (HBV), an influenza virus, or a respiratory syncytial virus (RSV) infection in a subject, the method comprising administering a therapeutic regimen comprising rapamycin, or variants thereof, and a viral vector encoding a broadly neutralizing antibody (including, but not limited to a HIV broadly neutralizing antibody, a HBV broadly neutralizing antibody, an influenza broadly neutralizing antibody, or a RSV broadly neutralizing antibody). In some embodiments, the broadly neutralizing antibody includes, but is not limited to 3BNC117, 10-1074, and PGT145. In some embodiments, the viral vector comprises an adeno- associated viral (AAV) vector. In some embodiments, rapamycin, or variants thereof, is administered one, two, three, or four weeks prior to administering the viral vector. In some embodiments, rapamycin, or variants thereof, is further administered 10 weeks or more following administering the viral vector. In some embodiments, rapamycin, or variant thereof, is administered one, two, three, four, five, six, or seven times per week. In some embodiments, rapamycin, or variants thereof, is administered by an intramuscular (i.m.) injection. Docket No.11348-047WO1 In some embodiments, the therapeutic regimen comprises administering one or more viral vectors encoding a 3BNC117 neutralizing antibody, a 10-1074 neutralizing antibody, or a PGT145 neutralizing antibody. In some embodiments, the one or more viral vectors are individually administered. In some embodiments, the viral vector is administered by an intramuscular (i.m.) injection. In some embodiments, the method expresses the neutralizing antibodies for more than 5 weeks. In some embodiments, the method expresses the neutralizing antibodies for more than 7 years. In some embodiments, the method expresses the neutralizing antibodies during a remainder of the subject’s life. In some embodiments, the AAV vector comprises an AAV9 serotype. In some embodiments, the therapeutic regimen is administered in combination with an antiviral agent selected from a nucleoside reverse transcriptase inhibitor, a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor, a fusion inhibitor, a CCR5 antagonist, an integrase strand transfer inhibitor, an attachment inhibitor, a post-attachment inhibitor, a capsid inhibitor, a CYP3A inhibitor, and combinations thereof. In some embodiments, the method decreases a viral load in the subject relative to an untreated subject with a viral infection. In one aspect, disclosed herein is a method of preventing and / or reducing an anti-drug antibody (ADA) response in a subject with a disease, wherein rapamycin is administered to the subject prior to administration of at least one viral vector-delivered antibody or antibody-like molecule. In some embodiments, at least one viral vector-delivered antibody or at least one antibody-like molecule comprises two or more antibody combinations. In some embodiments, at least one viral vector-delivered antibody or at least antibody-like molecule comprises a monoclonal antibody (mAb). In some embodiments, at least one viral vector-delivered antibody or at least one antibody-like molecule comprises an adeno-associated viral (AAV) vector. In some embodiments, the AAV vector comprises an AAV9 serotype. In some embodiments, the disease comprises an infectious disease. In some embodiments, the infectious disease comprises acquired immune deficiency syndrome / human immunodeficiency virus (AIDS / HIV), malaria, hepatitis A, hepatitis B, hepatitis C, influenza, or variants thereof. Docket No.11348-047WO1 In some embodiments, the ADA response comprises an immune response wherein the subject generates an antibody targeting at least one viral vector-delivered antibody or at least one antibody-like molecule. In one aspect, disclosed herein is a pharmaceutical kit comprising rapamycin, or variants thereof, and one or more viral vectors encoding a broadly neutralizing antibody including, but not limited to 3BNC117, 10-1074, and PGT145. In some embodiments, rapamycin, or variants thereof, is in a pharmaceutically acceptable carrier selected from an excipient, a diluent, a salt, a buffer, a stabilizer, a preservative, a lipid, an emulsion, and a nanoparticle. In some embodiments, the viral vector is in a pharmaceutically acceptable carrier selected from an excipient, a diluent, a salt, a buffer, a stabilizer, a preservative, a lipid, an emulsion, and a nanoparticle. In some embodiments, the viral vector comprises an adeno-associated viral (AAV) vector. In some embodiments, the AAV vector comprises an AAV9 serotype. In some embodiments, the kit is combined with an antiviral agent selected from a nucleoside reverse transcriptase inhibitor, a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor, a fusion inhibitor, a CCR5 antagonist, an integrase strand transfer inhibitor, an attachment inhibitor, a post-attachment inhibitor, a capsid inhibitor, a CYP3A inhibitor, and combinations thereof. In some embodiments, the kit treats or prevents a viral infection in a subject. In some embodiments, the kit reduces viral loads in the subject with the viral infection. In some embodiments, the kit reduces viral loads in a subject with Acquired Immunodeficiency Syndrome (AIDS). In some embodiments, the subject is a human. BRIEF DESCRIPTION OF FIGURES The accompanying figures, which are incorporated in and constitute a part of this specification, illustrate several aspects described below. FIG.1 shows the long-term continuous delivery of a monoclonal antibody using AAV vector administration. Naive rhesus monkey 84-05 received a single intramuscular administration of AAV vector expressing the rhesus monoclonal antibody (mAb) 5L7 on day zero. More than 6 years later, approximately 3% of the immunoglobulin circulating in this monkey is coming from the AAV vector put into its muscle more than 6 years earlier. Docket No.11348-047WO1 FIG.2 shows how the so-named “Miami Monkey” was infected with a SHIV (an SIV with an HIV-1 envelope gene) on day 0. Shown are ‘viral loads” measured as viral genome copies per ml of plasma. Viral loads until week 84 were in the range seen in HIV-1-infected people in the absence of anti-retroviral therapy. On week 84, the monkey received intramuscular inoculations of AAV vectors making three different anti-HIV neutralizing antibodies : 3BNC117, 10-1074 and 10-E8.10-E8 was not effectively delivered because of an anti-antibody response. But 3BNC117 and 10-1074 were effectively delivered. Herein, the administration shows it to be working and the monkey has been functionally cured. FIGS. 3A, 3B, 3C, and 3D demonstrates the issue that 80 to 90 % of AAV administrations result in a host antibody response to the mAb attempting to be delivered that negates its continuing presence. Four monkeys received an intramuscular injection of AAV vector making the 10E8 mAb. Green lines show the levels of 10E8 peaking at week 2 and then precipitously dropping. Blue lines show the levels of host monkey antibody responses to the 10E8 mAb attempting to be delivered. Thus, this is a problem restricting this approach from worldwide use. FIG.4 shows the levels of delivered anti-HIV mAb (top). The host antibody response to the anti-HIV mAbs (bottom). A host antibody response to 10E8 shows little or no delivery. No host antibody response to 3BNC117 and 10-1074 shows long-term continuous delivery. FIG. 5 shows that the inclusion of Rapamycin, an FDA-approved drug used to help prevent organ rejection in kidney transplants and certain types of cancers, allows long-term consistent delivery of 3BNC117 in 100% of mice. FIG.6 shows that the findings of FIG.5 are statistically highly different from mice that did not receive rapamycin. FIG.7 shows that the transient treatment of mice with rapamycin prevents an antibody response to AAV delivered 3BNC117 mAb. FIGS. 8A, 8B, and 8C show the viral reservoir size in three monkeys with long-term virologic control after AAV delivery of potent broadly-neutralizing monoclonal antibodies. In all three cases, the “competent HIV reservoir” has declined dramatically to below the limit of detection in two of the three monkeys, and the third monkey is at the limit of detection. Such declines are not typically seen in patients on long-term successful anti-retroviral therapy. FIGS. 9A, 9B, and 9C show that the three antibody-mediated functional cures of monkeys all show a dramatic decline in antibodies to the core protein, indicating antibody Docket No.11348-047WO1 responses to the HIV core protein p24, which does not typically decline in patients on long- term successful anti-retroviral therapy. FIGS. 10A and 10B show two additional examples of long-term functional cures following long-term delivery of potent broadly-neutralizing mAbs. FIG.11 shows the ability of rapamycin to prevent ADAs in a trial using 5 monkeys and AAV delivery of 3BNC117 mAb. FIG.12 shows the ability of rapamycin to prevent ADAs in a trial using 5 monkeys and AAV delivery of 10-1074 mAb. FIG.13 shows the ability of rapamycin to prevent ADAs in a trial using 5 monkeys and AAV delivery of PGT145 mAb. FIG. 14 shows the ability of rapamycin to allow continuous delivery of 3BNC117 in the same 5 monkey trial of FIG.13. FIG.15 shows the ability of rapamycin to allow continuous delivery of 10-1074 in the same 5 monkey trial of FIG.13. FIG.16 shows the ability of rapamycin to allow continuous delivery of PGT145 in the same 5 monkey trial of FIG.13. DETAILED DESCRIPTION The following description of the disclosure is provided as an enabling teaching of the disclosure in its best, currently known embodiment(s). To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various embodiments of the invention described herein, while still obtaining the beneficial results of the present disclosure. It will also be apparent that some of the desired benefits of the present disclosure can be obtained by selecting some of the features of the present disclosure without utilizing other features. Accordingly, those who work in the art will recognize that many modifications and adaptations to the present disclosure are possible and can even be desirable in certain circumstances and are a part of the present disclosure. Thus, the following description is provided as illustrative of the principles of the present disclosure and not in limitation thereof. Reference will now be made in detail to the embodiments of the invention, examples of which are illustrated in the drawings and the examples. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Docket No.11348-047WO1 Terminology Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. The term “comprising” and variations thereof as used herein is used synonymously with the term “including” and variations thereof and are open, non-limiting terms. Although the terms “comprising” and “including” have been used herein to describe various embodiments, the terms “consisting essentially of” and “consisting of” can be used in place of “comprising” and “including” to provide for more specific embodiments and are also disclosed. As used in this disclosure and in the appended claims, the singular forms “a”, “an”, “the”, include plural referents unless the context clearly dictates otherwise. The following definitions are provided for the full understanding of terms used in this specification. The terms "about" and "approximately" are defined as being “close to” as understood by one of ordinary skill in the art. In one non-limiting embodiment the terms are defined to be within 10%. In another non-limiting embodiment, the terms are defined to be within 5%. In still another non-limiting embodiment, the terms are defined to be within 1%. Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “about 10” is also disclosed. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “10” is disclosed the “less than or equal to 10”as well as “greater than or equal to 10” is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point 15 are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal Docket No.11348-047WO1 to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed. As used herein, the terms "may," "optionally," and "may optionally" are used interchangeably and are meant to include cases in which the condition occurs as well as cases in which the condition does not occur. Thus, for example, the statement that a formulation "may include an excipient" is meant to include cases in which the formulation includes an excipient as well as cases in which the formulation does not include an excipient. “Composition” refers to any agent that has a beneficial biological effect. Beneficial biological effects include both therapeutic effects, e.g., treatment of a disorder or other undesirable physiological condition, and prophylactic effects, e.g., prevention of a disorder or other undesirable physiological condition. The terms also encompass pharmaceutically acceptable, pharmacologically active derivatives of beneficial agents specifically mentioned herein, including, but not limited to, a vector, polynucleotide, cells, salts, esters, amides, proagents, active metabolites, inhibitors, isomers, fragments, analogs, and the like. When the term “composition” is used, then, or when a particular composition is specifically identified, it is to be understood that the term includes the composition per se as well as pharmaceutically acceptable, pharmacologically active vector (such as, for example, a viral vector or an AAV vector), polynucleotide, salts, esters, amides, proagents, conjugates, active metabolites, isomers, fragments, analogs, etc. A “therapeutic composition” refers to at least one substance, molecule, or compound suitable for administering to a subject, wherein the composition further includes a pharmaceutical carrier. A non-limiting example include a therapeutic composition comprises an inhibitor or an antibodies. As used herein, the term “agent” or “therapeutic agent” refers to a living organism or biological substance, such as a virus, chemical, toxin, or antibody, that can be designed to purposefully fulfill a biological function or action. As used herein, a “therapeutic regimen” refers to a structured treatment plan or strategy designed to improve and maintain health. Generally, a therapeutic regimen will be designed, prescribed, and / or administered by a licensed medical practitioner. The therapeutic regimen generally specifies the treatment dosage, the treatment scheduling, and the duration of the treatment. In some embodiments, the therapeutic regimen comprises one or more therapeutic compositions. In some embodiments, the therapeutic regimen comprises one or more Docket No.11348-047WO1 therapeutic agents. In some embodiments, the therapeutic regimen comprises any combination of therapeutic compositions and therapeutic agents, such as for example the combination of an inhibitor and an antibody. In some embodiments, a therapeutic regimen comprises modifying, continuing, and / or initiating at least one therapeutic agent and / or therapeutic composition. In some embodiments, a therapeutic regimen comprises treating and / or preventing a disease, disorder, and / or condition. The term “comprising”, and variations thereof as used herein is used synonymously with the term “including” and variations thereof and are open, non-limiting terms. Although the terms “comprising” and “including” have been used herein to describe various embodiments, the terms “consisting essentially of” and “consisting of” can be used in place of “comprising” and “including” to provide for more specific embodiments and are also disclosed. An "increase" can refer to any change that results in a greater amount of a symptom, disease, composition, condition, or activity. An increase can be any individual, median, or average increase in a condition, symptom, activity, composition in a statistically significant amount. Thus, the increase can be a 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% increase so long as the increase is statistically significant. A "decrease" can refer to any change that results in a smaller amount of a symptom, disease, composition, condition, or activity. A substance is also understood to decrease the genetic output of a gene when the genetic output of the gene product with the substance is less relative to the output of the gene product without the substance. Also, for example, a decrease can be a change in the symptoms of a disorder such that the symptoms are less than previously observed. A decrease can be any individual, median, or average decrease in a condition, symptom, activity, composition in a statistically significant amount. Thus, the decrease can be a 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% decrease so long as the decrease is statistically significant. "Inhibit," "inhibiting," and "inhibition" mean to decrease an activity, response, condition, disease, or other biological parameter. This can include but is not limited to the complete ablation of the activity, response, condition, or disease. This may also include, for example, a 10% reduction in the activity, response, condition, or disease as compared to the native or control level. Thus, the reduction can be a 10, 20, 30, 40, 50, 60, 70, 80, 90, 100%, or any amount of reduction in between as compared to native or control levels. Docket No.11348-047WO1 “Inhibitors” or “antagonist” of expression or of activity are used to refer to inhibitory molecules, respectively, identified using in vitro and in vivo assays for expression or activity of a described target protein, e.g., ligands, antagonists, and their homologs and mimetics. Inhibitors are agents that, e.g., inhibit expression or bind to, partially or totally block stimulation or activity, decrease, prevent, delay activation, inactivate, desensitize, or down regulate the activity of the described target protein, e.g., antagonists. Control samples (untreated with inhibitors) are assigned a relative activity value of 100%. Inhibition of a described target protein is achieved when the activity value relative to the control is about 80%, optionally 50% or 25, 10%, 5%, or 1% or less. By “reduce” or other forms of the word, such as “reducing” or “reduction,” means lowering of an event or characteristic (e.g., viral load). It is understood that this is typically in relation to some standard or expected value, in other words it is relative, but that it is not always necessary for the standard or relative value to be referred to. For example, “reduces viral load” means reducing the amount of virus or virus particles in an infected person’s blood relative to a standard or a control. By “prevent” or other forms of the word, such as “preventing” or “prevention,” is meant to stop a particular event or characteristic, to stabilize or delay the development or progression of a particular event or characteristic, or to minimize the chances that a particular event or characteristic will occur. Prevent does not require comparison to a control as it is typically more absolute than, for example, reduce. As used herein, something could be reduced but not prevented, but something that is reduced could also be prevented. Likewise, something could be prevented but not reduced, but something that is prevented could also be reduced. It is understood that where reduce or prevent are used, unless specifically indicated otherwise, the use of the other word is also expressly disclosed. The term “subject” refers to any individual who is the target of administration or treatment. The subject can be a vertebrate, for example, a mammal. In one aspect, the subject can be human, non-human primate, bovine, equine, porcine, canine, or feline. Thus, the subject can be a human or veterinary patient. The term “patient” refers to a subject under the treatment of a clinician, e.g., physician. The term “treatment” refers to the medical management of a patient with the intent to cure, ameliorate, stabilize, or prevent a disease, pathological condition, or disorder. This term includes active treatment, that is, treatment directed specifically toward the improvement of a disease, pathological condition, or disorder, and also includes causal treatment, that is, Docket No.11348-047WO1 treatment directed toward removal of the cause of the associated disease, pathological condition, or disorder. In addition, this term includes palliative treatment, that is, treatment designed for the relief of symptoms rather than the curing of the disease, pathological condition, or disorder; preventative treatment, that is, treatment directed to minimizing or partially or completely inhibiting the development of the associated disease, pathological condition, or disorder; and supportive treatment, that is, treatment employed to supplement another specific therapy directed toward the improvement of the associated disease, pathological condition, or disorder. The term “administer,” “administering”, or derivatives thereof refer to delivering a composition, substance, inhibitor, or medication to a subject or object by one or more the following routes: oral, topical, intravenous, subcutaneous, transcutaneous, transdermal, intramuscular, intra-joint, parenteral, intra-arteriole, intradermal, intraventricular, intracranial, intraperitoneal, intralesional, intranasal, rectal, vaginal, by inhalation or via an implanted reservoir. The term “parenteral” includes subcutaneous, intravenous, intramuscular, intra- articular, intra-synovial, intrasternal, intrathecal, intrahepatic, intralesional, and intracranial injections or infusion techniques. The term "antibody" is used in the broadest sense, and specifically covers monoclonal antibodies (including full length monoclonal antibodies), polyclonal antibodies, and multispecific antibodies (e.g., bispecific antibodies). Antibodies (Abs) are glycoproteins that exhibit binding specificity to a specific target. Native antibodies are usually heterotetrameric glycoproteins of about 150,000 daltons, composed of two identical light (L) chains and two identical heavy (H) chains. Each heavy chain has at one end a variable domain (VH) followed by a number of constant domains. Each light chain has a variable domain at one end (VL) and a constant domain at its other end. The term "antibody fragment" refers to a portion of a full-length antibody, generally the target binding or variable region. Examples of antibody fragments include Fab, Fab', F(ab')2and Fv fragments. The phrase "functional fragment or analog" of an antibody is a compound having qualitative biological activity in common with a full-length antibody. For example, a functional fragment or analog of an anti-IgE antibody is one which can bind to an IgE immunoglobulin in such a manner so as to prevent or substantially reduce the ability of such molecule from having the ability to bind to the high affinity receptor, FcεRI. As used herein, "functional fragment" with respect to antibodies, refers to Fv, F(ab) and F(ab')2fragments. An "Fv" fragment is the minimum antibody fragment which contains a complete target recognition Docket No.11348-047WO1 and binding site. This region consists of a dimer of one heavy and one light chain variable domain in a tight, non-covalent association (VH-VL dimer). It is in this configuration that the three CDRs of each variable domain interact to define a target binding site on the surface of the VH-VL dimer. Collectively, the six CDRs confer target binding specificity to the antibody. However, even a single variable domain (or half of an Fv comprising only three CDRs specific for a target) has the ability to recognize and bind target, although at a lower affinity than the entire binding site. "Single-chain Fv" or "sFv" antibody fragments comprise the VHand VLdomains of an antibody, wherein these domains are present in a single polypeptide chain. Generally, the Fv polypeptide further comprises a polypeptide linker between the VHand VLdomains which enables the sFv to form the desired structure for target binding. The term “monoclonal antibody” as used herein refers to an antibody obtained from a substantially homogeneous population of antibodies, i.e., the individual antibodies within the population are identical except for possible naturally occurring mutations that may be present in a small subset of the antibody molecules. The term "variable" in the context of variable domain of antibodies, refers to the fact that certain portions of the variable domains differ extensively in sequence among antibodies and are used in the binding and specificity of each particular antibody for its particular target. However, the variability is not evenly distributed through the variable domains of antibodies. It is concentrated in three segments called complementarity determining regions (CDRs) also known as hypervariable regions both in the light chain and the heavy chain variable domains. The more highly conserved portions of variable domains are called the framework (FR). The variable domains of native heavy and light chains each comprise four FR regions, largely an adopting a .beta.-sheet configuration, connected by three CDRs, which form loops connecting, and in some cases forming part of, the .beta.-sheet structure. The CDRs in each chain are held together in close proximity by the FR regions and, with the CDRs from the other chain, contribute to the formation of the target binding site of antibodies (see Kabat et al.) As used herein, numbering of immunoglobulin amino acid residues is done according to the immunoglobulin amino acid residue numbering system of Kabat et al., (Sequences of Proteins of Immunological Interest, National Institute of Health, Bethesda, Md.1987), unless otherwise indicated. A “vaccine” refers to a biological preparation that provides active acquired immunity to a particular infectious diseases caused by a microorganism, such as, for example, a virus. Vaccines typically comprise an agent or several agents, also referred to as antigens, resembling Docket No.11348-047WO1 the microorganism and is often made from weakened or killed forms of the microbe, its toxins, or its surface proteins / peptides. Vaccines are also made to comprise additional components, such as adjuvants, preservatives, and / or stabilizers to boost the immune response, improve safety, and improve vaccine storage. The terms “treat,” “treating,” and grammatical variations thereof as used herein, include partially or completely delaying, alleviating, mitigating, or reducing the intensity of one or more attendant symptoms of a disorder or condition and / or alleviating, mitigating, or impeding one or more causes of a disorder or condition. Treatments according to the disclosure may be applied preventively, prophylactically, palliatively, or remedially. Treatments are administered to a subject during early onset (e.g., upon initial signs and symptoms of infection), or after an established development of infection. “Serotype” as used herein refers to a distinct variation within a species of bacteria or virus or among immune cells of different individuals. These microorganisms, viruses, or cells are classified together based on their surface antigens, allowing the epidemiologic classification of organisms to the subspecies level. As used herein, the term “infection” refers to the invasion of tissues by pathogens, their multiplication, and reaction of host tissues to the infectious agent and any toxins they release. Infections can be caused by a wide range of pathogen, most common are bacteria and viruses. A “vector” as used herein refers to any particle or composition used as a vehicle to artificially carry a foreign nucleic acid sequence into another cell, where it can be replicated and / or expressed. Examples of vectors include plasmids, viral vectors, cosmids, and artificial chromosomes. As used herein a “viral vector” refers to a tool used in molecular biology to deliver genetic material (including DNA, RNA, and any other nucleic acid variations thereof) into a cell. This process is performed either inside a living organism or in cell culture. The viral genome is engineered to incorporate a desired gene or gene product, and following transduction, or transfer, of the virus into the host, said gene or gene product is expressed within the host. An “adeno-associated virus” or an “AAV” as used herein refers to a small virus belonging to the genus Dependoparvovirus which are replicative defective, non-enveloped viruses with linear single-stranded DNA. These viruses are commonly used for creating viral vectors for gene therapy, wherein said viruses can infect dividing and quiescent cells and persist in an extrachromosomal state without integrating into the host genome. AAVs can be Docket No.11348-047WO1 engineered to express desired genes or gene products such as mRNA, shRNA, or miRNAs to overexpress or silence a target gene. A “variant” or a “derivative” of a particular inhibitor may be defined as a chemical or molecular compound having at least 50% identity to a parent or original inhibitor. In some embodiments a variant inhibitor may show, for example, at least 60%, at least 70%, at least 80%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% or greater identity relative to a reference parent or original inhibitor. A “virus” is a microscopic infectious agent that replicates only inside the living cells of an organism. Viruses can infect all life forms, including mammalian and non-mammalian animals, plants, and other microorganisms. A complete virus, also known as a virion, consists of nucleic acid genetic material surrounded by a protective coat of protein called a capsid. Virus can have a lipid envelope derived from the infected host cell membrane. In general, there are five morphological virus types including helical, icosahedral, prolate, enveloped, and complex virus. A virus can either have a DNA or RNA genome, though a vast majority have RNA genomes. Irrespective of the type of nucleic acid genome, a viral genome can be either a single- stranded genome or a double-stranded genome. An “epitope” or “antigenic determinant” refer to the part of an antigen, a molecular structure, or foreign particulate that can bind to a specific antibody or T-cell receptor. The presence of antigens or epitopes of antigens within a host can illicit an immune response. Methods of treating and / or preventing infectious diseases The present disclosure provides methods of treating and / or preventing infectious diseases, including, but not limited to Human immunodeficiency virus (HIV). Human immunodeficiency virus (HIV) or human immunodeficiency virus-1 (HIV-1) is the causative pathogen of acquired immunodeficiency syndrome (AIDS) and mainly infects CD4+T cells leading to progressive damage of the immune system. Without defense and surveillance functions of the immune system, patients with an HIV infection are more susceptible to other pathogenic infections and gene mutations, resulting in opportunistic infections, cancers, and even death. Recent efforts have led to development of broadly neutralizing antibodies (bNAbs) as an approach to treat, prevent, and ideally eradicate HIV infections. However, administration of said bNAbs are complex due to short half-lives and launching an adverse immune response within the patients. Thus, there remains a need to Docket No.11348-047WO1 improve administration by prolonging the effects of the bNAbs without eliciting harmful immune responses in patients. As used herein, a ”broadly neutralizing antibody” or “bNAb” refers to a specific group of antibodies which neutralize multiple viral strains including, but not limited to HIV-1 viral strains, by targeting conserved epitopes of HIV, meaning that even if the virus mutates then the targeted epitopes still exist. In one aspect, disclosed herein is method of treating or preventing a Human Immunodeficiency Virus (HIV), a Hepatitis B Virus (HBV), an influenza virus, or a respiratory syncytial virus (RSV) infection in a subject, the method comprising administering a therapeutic regimen comprising rapamycin, or variants thereof, and a viral vector encoding a broadly neutralizing antibody (including, but not limited to a HIV broadly neutralizing antibody, a HBV broadly neutralizing antibody, an influenza broadly neutralizing antibody, or a RSV broadly neutralizing antibody). In one aspect, disclosed herein is method of treating or preventing a Human Immunodeficiency Virus (HIV) in a subject, the method comprising administering a therapeutic regimen comprising rapamycin, or variants thereof, and a viral vector encoding a HIV broadly neutralizing antibody. In some embodiments, the rapamycin variant comprises tacrolimus or a combination of rapamycin and tacrolimus. It should be noted that the therapeutic regimen comprises administering rapamycin, or variants thereof. As used herein, rapamycin, or variants thereof, are immunosuppressive agents administered prior to the bNAbs. Thus, the therapeutic regimen comprises administering an immunosuppressive agents, including, but not limited to rapamycin (Sirolimus), tacrolimus (Prograf), prednisone, everolimus, and mycophenolate mofetil. In some embodiments, an immunosuppressive agent comprises a rapamycin-related analog (or mTOR inhibitors) including, but not limited to Temsirolimus, Everolimus, Umirolimus, Zotarolimus, Torin-1, Torin-2, Vistusertib, and other mTOR inhibitors. It should also be noted that administration of rapamycin begins at week minus 1 (-1), week minus 2 (-2), week minus 3 (-3), or week minus 4 (-4) relative to the day of the viral vector administration, wherein the day of viral vector administration begins at week 0. Furthermore, rapamycin administration can be continued for 8 weeks or more following administering the viral vector. In some embodiments, rapamycin, or variants thereof, is administered 1, 2, 3, 4, or 5 days prior to administering the viral vector. In some embodiments, rapamycin, or variants Docket No.11348-047WO1 thereof, is further administered for at least 5 weeks following administering the viral vector. In some embodiments, rapamycin, or variants thereof, is administered 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 16 weeks, 17 weeks, 18 weeks, 19 weeks, 20 weeks, or more following administering the viral vector. In a preferred embodiment, rapamycin, or variants thereof, is administered 8 weeks, 9 weeks, 10 weeks, 11 weeks, or 12 weeks following administering the viral vector. In some embodiments, rapamycin, or variants thereof, is administered at least once per week. In some embodiments, rapamycin, or variants thereof, is administered one, two, three, four, five, six, seven, or more per week. In some embodiments, rapamycin, or variants thereof, is administered seven times per week. In some embodiments, rapamycin , or variants thereof, is administered once per day. In some embodiments, rapamycin, or variants thereof, is administered by an intraperitoneal (i.p.) injection. In some embodiments, rapamycin, or variants thereof, is administered intramuscularly. In some embodiments, rapamycin, or variants thereof, is administered intravenously. In some embodiments, the viral vector encodes a broadly neutralizing HIV antibody including, but not limited to 3BNC117, 10-1074, PGT145, 10E8, N6,35022, 447-52D, 2G12, b12, 2F5, 4E10, Z13, PG9, PG16, PGT141, PGT142, PGT143, PGT144, CH01, CH02, CH03, CH04, PGDM1400, CAP256-VRC26.25, VRC38, PCT64, PGT121, PGT128, PGT135, PCDN-33A, PGDM12, PGDM21, VRC29.03, BF520.1, VRC41.01, BG18, DH270.1, DH270.6, VRC01, PGV04, 8ANC131, CH103, CH235, N6, IOMA, N49-P7, PGT151, PGT152, PGT153, PGT154, PGT155, PGT156, PGT157, PGT158, 8ANC195, 35022, N123- VRC34.01, ACS202, VRC-PG05, SF12, DH511, and variants thereof. In some embodiments, the broadly neutralizing antibody of any preceding aspect further comprises a half-life extender, such as for example a Xencor half-life extender. In some embodiments, the viral vector comprises an adeno-associated viral (AAV) vector. In some embodiments, the therapeutic regimen comprises administering one or more viral vectors encoding a 3BNC117 neutralizing antibody, a 10-1074 neutralizing antibody, or a PGT145 neutralizing antibody. In some embodiments, the therapeutic regimen comprises administering 3BNC117 and 10-1074 neutralizing antibodies. In some embodiments, the therapeutic regimen comprises administering 3BNC117 and PGT145 neutralizing antibodies. In some embodiments, the therapeutic regimen comprises administering 10-1074 and PGT145 Docket No.11348-047WO1 neutralizing antibodies. In some embodiments, the therapeutic regimen comprises administering 3BNC117, 101074, and PGT145 neutralizing antibodies. In some embodiments, the one or more viral vectors are individually administered. In some embodiments, the viral vector is administered by an intramuscular (i.m.) injection. In some embodiments, the method expresses the neutralizing antibodies for more than 5 weeks. In some embodiments, the method expresses the neutralizing antibodies for about 10 weeks to about 400 weeks. In some embodiments, the method expresses the neutralizing antibodies for 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217, 218, 219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 253, 254, 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273, 274, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 285, 286, 287, 288, 289, 290, 291, 292, 293, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304, 305, 306, 307, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 327, 328, 329, 330, 331, 332, 333, 334, 335, 336, 337, 338, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 350, 351, 352, 353, 354, 355, 356, 357, 358, 359, 360, 361, 362, 363, 364, 365, 366, 367, 368, 369, 370, 371, 372, 373, 374, 375, 376, 377, 378, 379, 380, 381, 382, 383, 384, 385, 386, 387, 388, 389, 390, 391, 392, 393, 394, 395, 396, 397, 398, 399, 400 weeks or more. In some embodiments, the method expresses the neutralizing antibodies for the remainder of the subject’s life. Viral vectors are molecular tools used to deliver genetic material into cells that can be performed inside a living organism (in vivo), or in cell culture (in vitro). In some embodiments, the viral vector includes, but is not limited to adeno-associated viral (AAV) vectors, adenoviral vectors, retroviral vectors, lentiviral vectors, and hybrid viral vectors. Docket No.11348-047WO1 Retroviral Vectors A retrovirus is an animal virus belonging to the virus family of Retroviridae, including any types, subfamilies, genus, or tropisms. Retroviral vectors, in general, are described by Verma, I.M., Retroviral vectors for gene transfer. A retrovirus is essentially a package which has packed into it nucleic acid cargo. The nucleic acid cargo carries with it a packaging signal, which ensures that the replicated daughter molecules will be efficiently packaged within the package coat. In addition to the package signal, there are a number of molecules which are needed in cis, for the replication, and packaging of the replicated virus. Typically, a retroviral genome contains the gag, pol, and env genes which are involved in the making of the protein coat. It is the gag, pol, and env genes which are typically replaced by the foreign DNA that it is to be transferred to the target cell. Retrovirus vectors typically contain a packaging signal for incorporation into the package coat, a sequence which signals the start of the gag transcription unit, elements necessary for reverse transcription, including a primer binding site to bind the tRNA primer of reverse transcription, terminal repeat sequences that guide the switch of RNA strands during DNA synthesis, a purine rich sequence 5' to the 3' LTR that serve as the priming site for the synthesis of the second strand of DNA synthesis, and specific sequences near the ends of the LTRs that enable the insertion of the DNA state of the retrovirus to insert into the host genome. The removal of the gag, pol, and env genes allows for about 8 kb of foreign sequence to be inserted into the viral genome, become reverse transcribed, and upon replication be packaged into a new retroviral particle. This amount of nucleic acid is sufficient for the delivery of a one to many genes depending on the size of each transcript. It is preferable to include either positive or negative selectable markers along with other genes in the insert. Since the replication machinery and packaging proteins in most retroviral vectors have been removed (gag, pol, and env), the vectors are typically generated by placing them into a packaging cell line. A packaging cell line is a cell line which has been transfected or transformed with a retrovirus that contains the replication and packaging machinery, but lacks any packaging signal. When the vector carrying the DNA of choice is transfected into these cell lines, the vector containing the gene of interest is replicated and packaged into new retroviral particles, by the machinery provided in cis by the helper cell. The genomes for the machinery are not packaged because they lack the necessary signals. Adenoviral Vectors Docket No.11348-047WO1 The construction of replication-defective adenoviruses has been described (Berkner et al., J. Virology 61:1213-1220 (1987); Massie et al., Mol. Cell. Biol.6:2872-2883 (1986); Haj- Ahmad et al., J. Virology 57:267-274 (1986); Davidson et al., J. Virology 61:1226-1239 (1987); Zhang "Generation and identification of recombinant adenovirus by liposome- mediated transfection and PCR analysis" BioTechniques 15:868-872 (1993)). The benefit of the use of these viruses as vectors is that they are limited in the extent to which they can spread to other cell types, since they can replicate within an initial infected cell, but are unable to form new infectious viral particles. Recombinant adenoviruses have been shown to achieve high efficiency gene transfer after direct, in vivo delivery to airway epithelium, hepatocytes, vascular endothelium, CNS parenchyma and a number of other tissue sites (Morsy, J. Clin. Invest.92:1580-1586 (1993); Kirshenbaum, J. Clin. Invest.92:381-387 (1993); Roessler, J. Clin. Invest. 92:1085-1092 (1993); Moullier, Nature Genetics 4:154-159 (1993); La Salle, Science 259:988-990 (1993); Gomez-Foix, J. Biol. Chem. 267:25129-25134 (1992); Rich, Human Gene Therapy 4:461-476 (1993); Zabner, Nature Genetics 6:75-83 (1994); Guzman, Circulation Research 73:1201-1207 (1993); Bout, Human Gene Therapy 5:3-10 (1994); Zabner, Cell 75:207-216 (1993); Caillaud, Eur. J. Neuroscience 5:1287-1291 (1993); and Ragot, J. Gen. Virology 74:501-507 (1993)). Recombinant adenoviruses achieve gene transduction by binding to specific cell surface receptors, after which the virus is internalized by receptor-mediated endocytosis, in the same manner as wild type or replication-defective adenovirus (Chardonnet and Dales, Virology 40:462-477 (1970); Brown and Burlingham, J. Virology 12:386-396 (1973); Svensson and Persson, J. Virology 55:442-449 (1985); Seth, et al., J. Virol. 51:650-655 (1984); Seth, et al., Mol. Cell. Biol. 4:1528-1533 (1984); Varga et al., J. Virology 65:6061-6070 (1991); Wickham et al., Cell 73:309-319 (1993)). A viral vector can be one based on an adenovirus which has had the E1 gene removed and these virons are generated in a cell line such as the human 293 cell line. In another preferred embodiment both the E1 and E3 genes are removed from the adenovirus genome. Adeno-associated viral vectors Another type of viral vector is based on an adeno-associated virus (AAV). This defective parvovirus is a preferred vector because it can infect many cell types and is nonpathogenic to humans. AAV type vectors can transport about 4 to 5 kb and wild type AAV is known to stably insert into chromosome 19. Vectors which contain this site specific integration property are preferred. An especially preferred embodiment of this type of vector is the P4.1 C vector produced by Avigen, San Francisco, CA, which can contain the herpes Docket No.11348-047WO1 simplex virus thymidine kinase gene, HSV-tk, and / or a marker gene, such as the gene encoding the green fluorescent protein, GFP. In another type of AAV virus, the AAV contains a pair of inverted terminal repeats (ITRs) which flank at least one cassette containing a promoter which directs cell-specific expression operably linked to a heterologous gene. Heterologous in this context refers to any nucleotide sequence or gene which is not native to the AAV or B19 parvovirus. Typically the AAV and B19 coding regions have been deleted, resulting in a safe, noncytotoxic vector. The AAV ITRs, or modifications thereof, confer infectivity and site- specific integration, but not cytotoxicity, and the promoter directs cell-specific expression. United states Patent No. 6,261,834 is herein incorporated by reference for material related to the AAV vector. Large payload viral vectors Molecular genetic experiments with large human herpesviruses have provided a means whereby large heterologous DNA fragments can be cloned, propagated and established in cells permissive for infection with herpesviruses (Sun et al., Nature genetics 8: 33-41, 1994; Cotter and Robertson,.Curr Opin Mol Ther 5: 633-644, 1999). These large DNA viruses (herpes simplex virus (HSV) and Epstein-Barr virus (EBV), have the potential to deliver fragments of human heterologous DNA > 150 kb to specific cells. EBV recombinants can maintain large pieces of DNA in the infected B-cells as episomal DNA. Individual clones carried human genomic inserts up to 330 kb appeared genetically stable The maintenance of these episomes requires a specific EBV nuclear protein, EBNA1, constitutively expressed during infection with EBV. Additionally, these vectors can be used for transfection, where large amounts of protein can be generated transiently in vitro. Herpesvirus amplicon systems are also being used to package pieces of DNA > 220 kb and to infect cells that can stably maintain DNA as episomes. Other useful systems include, for example, replicating and host-restricted non- replicating vaccinia virus vectors. In some embodiments, the AAV vector comprises an AAV9 serotype. In some embodiments, the AAV vector comprises an AAV6 serotype. In some embodiments, the AAV vector comprises an AAV1, AAV2, AAV3, AAV4, AAV5, AAV7, or AAV8 serotype. In some embodiments, the therapeutic regimen is administered in combination with an antiviral agent selected from a nucleoside reverse transcriptase inhibitor, a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor, a fusion inhibitor, a CCR5 antagonist, an Docket No.11348-047WO1 integrase strand transfer inhibitor, an attachment inhibitor, a post-attachment inhibitor, a capsid inhibitor, a CYP3A inhibitor, and combinations thereof. In some embodiments, the therapeutic regimen further comprises administering additional immunotherapeutic agents or compositions including, but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors, CAR-T cells, vaccines, and immunomodulatory agents (i.e.: interferons and / or interleukins). In some embodiments, the method suppresses the immune response in the subject relative to an untreated subject with a viral infection. In some embodiments, the method suppresses the immune response in the subject by 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, or more relative to an untreated subject with a viral infection. In some embodiments, the method decreases viral loads in the subject relative to an untreated subject with a viral infection. In some embodiments, the method decreases viral loads in the subject by 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 100%, or more relative to an untreated subject with a viral infection. The therapeutic regimen may be administered in such amounts, time, and route deemed necessary in order to achieve the desired result. The exact amount of the therapeutic regimen will vary from subject to subject, depending on the species, age, and general condition of the subject, the severity of the infection, the particular therapeutic regimen, its mode of administration, its mode of activity, and the like. The therapeutic regimen is preferably formulated in dosage unit form for ease of administration and uniformity of dosage. It will be understood, however, that the total daily usage of the therapeutic regimen will be decided by the attending physician within the scope of sound medical judgment. The specific therapeutically effective dose level for any particular subject will depend upon a variety of factors including the infection being treated and the severity of the infection; the activity of the therapeutic regimen employed; the specific therapeutic regimen employed; the age, body weight, general health, sex and diet of the patient; the time of administration, route of administration, and rate of excretion of the specific therapeutic regimen employed; the duration of the treatment; drugs used in combination or coincidental with the specific therapeutic regimen employed; and like factors well known in the medical arts. The therapeutic regimen may be administered by any route. In some embodiments, the therapeutic regimen is administered via a variety of routes, including intravenous, intraperitoneal, intramuscular, intra-arterial, intramedullary, intrathecal, subcutaneous, Docket No.11348-047WO1 intraventricular, transdermal, interdermal, mucosal, nasal, oral, buccal, enteral, sublingual; by intratracheal instillation, bronchial instillation, and / or inhalation; and / or as an oral spray, nasal spray, and / or aerosol. In general, the most appropriate route of administration will depend upon a variety of factors including the nature of the therapeutic regimen (e.g., its stability in the environment of the body), the condition of the subject (e.g., whether the subject is able to tolerate administration by injection), etc. In some embodiments, the therapeutic regimen of any preceding aspect can be administered by in vivo electroporation. As used herein, “in vivo electroporation” refers to a physical method of gene transfer, wherein a series of electric or mechanical pulses are delivered through a subject’s intact tissue or cell for a short duration of time to enhance the transfer of macromolecules, including but not limited to DNA, RNA, and proteins. In some embodiments, the rapamycin, rapamycin-related analogs, or variants thereof of any preceding aspect administered by ways known in the art to maintain long-acting release or sustained release. In some embodiments, the rapamycin, rapamycin-related analogs, or variants thereof of any preceding aspect administered as components of a prodrug. As used herein, a “prodrug” refers to a compound with little or no pharmacological activity upon administration, but is metabolized inside the body and is converted into a pharmacologically active drug compound. The exact amount of the therapeutic regimen required to achieve a therapeutically effective amount will vary from subject to subject, depending on species, age, weight, and general condition of a subject, severity of the side effects, identity of the particular compound(s), mode of administration, and the like. The amount to be administered to, for example, a child or an adolescent can be determined by a medical practitioner or person skilled in the art and can be lower or the same as that administered to an adult. Methods of preventing and / or reducing an anti-drug antibody response Anti-drug antibody (ADA) responses refers to immune responses caused by an antibody binding to the epitope of another antibody including, but not limited to an antibody drug. Such processes cause adverse events in a subject, including inflammation and cytokine storms (also referred to when too many cytokines are released into the bloodstream to quickly), however the most common problem caused is loss of drug efficacy, drug neutralization, and / or drug elimination. Current practices test for ADA after a drug is delivered to the subject, however there are limited techniques that actively prevent, reduce, and / or decrease ADA. Docket No.11348-047WO1 In one aspect, disclosed herein is a method of preventing and / or reducing an anti-drug antibody (ADA) response in a subject with a disease, wherein rapamycin, or a variant thereof, is administered to the subject prior to administration of at least one viral vector-delivered antibody or antibody-like molecule. In some embodiments, rapamycin (Sirolimus), tacrolimus (Prograf), prednisone, everolimus, or mycophenolate mofetil are administered to prevent or reduce an ADA response. In some embodiments, Temsirolimus, Everolimus, Umirolimus, Zotarolimus, Torin-1, Torin-2, Vistusertib, and other mTOR inhibitors are administered to prevent or reduce an ADA response. In some embodiments, rapamycin, or a variant thereof, is used to prevent ADA in the passive administration of broadly neutralizing antibodies. In some embodiments, the at least one viral vector-delivered antibody or antibody-like molecule comprises one antibody, or two or more antibody combinations. In some embodiments, the at least one viral vector-delivered antibody or antibody-like molecule comprises a monoclonal antibody (mAb). In some embodiments, the at least one viral vector- delivered antibody or antibody-like molecule comprises an adeno-associated viral (AAV) vector. In some embodiments, the AAV vector comprises an AAV9 serotype. In some embodiments, the at least one viral vector-delivered antibody or antibody-like molecule comprises an adenoviral vector, a retroviral vector, a lentiviral vector, or a hybrid viral vector. In some embodiments, the disease comprises an infectious disease. In some embodiments, the infectious disease includes, but is not limited to Human immunodeficiency virus (HIV). In some embodiments, the kit is used to treat and / or prevent HIV, common cold, influenza (including, but not limited to human, bovine, avian, porcine, and simian strains of influenza), measles, acquired immune deficiency syndrome / human immunodeficiency virus (AIDS / HIV), anthrax, botulism, cholera, campylobacter infections, chickenpox, chlamydia infections, cryptosporidosis, dengue fever, diphtheria, hemorrhagic fevers, Escherichia coli (E. coli) infections, ehrlichiosis, gonorrhea, hand-foot-mouth disease, hepatitis A, hepatitis B, hepatitis C, legionellosis, leprosy, leptospirosis, listeriosis, malaria, meningitis, meningococcal disease, mumps, pertussis, polio, pneumococcal disease, paralytic shellfish poisoning, rabies, rocky mountain spotted fever, rubella, salmonella, shigellosis, small pox, syphilis, tetanus, trichinosis (trichinellosis), tuberculosis (TB), typhoid fever, typhus, west Nile virus, yellow fever, yersiniosis, and zika. In some embodiments, the disease comprises a proliferative disease and / or cancer. In some embodiments, the method prevents and / or reduces an ADA caused by one or more diseases of any preceding aspect. In some embodiments, the method inhibits and / or Docket No.11348-047WO1 prevents an ADA from biological treatments (including, but not limited to anti-human IgE antibodies) used from gastrointestinal complications and / or allergies. In some embodiments, the ADA response comprises an immune response wherein the subject generates an antibody targeting the at least one viral vector-delivered antibody or antibody-like molecule. Pharmaceutical Kits The present disclosure also provides a kit for the treatment and / or prevention of disease or disorder including, but not limited to infectious diseases and proliferative diseases including cancer. In one aspect, disclosed herein is a pharmaceutical kit comprising rapamycin, or variants thereof, and one or more viral vectors encoding a broadly neutralizing antibody. In some embodiments, the broadly neutralizing antibody includes, but is not limited to 3BNC117, 10-1074, and PGT145. In some embodiments, the broadly neutralizing antibody of any preceding aspect further comprises a half-life extender, such as for example a Xencor half- life extender). In some embodiments, rapamycin, or variants thereof, is in a pharmaceutically acceptable carrier selected from an excipient, a diluent, a salt, a buffer, a stabilizer, a preservative, a lipid, an emulsion, and a nanoparticle. In some embodiments, the viral vector is in a pharmaceutically acceptable carrier selected from an excipient, a diluent, a salt, a buffer, a stabilizer, a preservative, a lipid, an emulsion, and a nanoparticle. In some embodiments, the viral vector comprises an adeno-associated viral (AAV) vector. In some embodiments, the AAV vector comprises an AAV9 serotype. In some embodiments, the kit is combined with an antiviral agent selected from a nucleoside reverse transcriptase inhibitor, a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor, a fusion inhibitor, a CCR5 antagonist, an integrase strand transfer inhibitor, an attachment inhibitor, a post-attachment inhibitor, a capsid inhibitor, a CYP3A inhibitor, and combinations thereof. In some embodiments, said kit treats or prevents a viral infection in a subject. In some embodiments, the kit treats or prevents infection from a virus, a bacterium, or other pathogenic microorganisms. In some embodiments, said kit reduces viral loads in the subject with the viral infection. In some embodiments, the kit reduces viral loads by 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 99%, 100%, or more in the subject with the viral infection. Docket No.11348-047WO1 In some embodiments, said kit reduces viral loads in a subject with Acquired Immunodeficiency Syndrome (AIDS). In some embodiments, the kit reduces viral loads by 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 99%, 100%, or more in the subject with AIDS. In some embodiments, the subject is a human. A number of embodiments of the disclosure have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims. By way of non-limiting illustration, examples of certain embodiments of the present disclosure are given below. EXAMPLES The following examples are set forth below to illustrate the compositions, devices, methods, and results according to the disclosed subject matter. These examples are not intended to be inclusive of all aspects of the subject matter disclosed herein, but rather to illustrate representative methods and results. These examples are not intended to exclude equivalents and variations of the present invention which are apparent to one skilled in the art. Example 1: Methods and Results in Mice and Monkeys Functional Cures Three monkeys have been definitively shown to have long-term functional cures of their infection by SHIV strain AD8eo. All three had long-term delivery of two monoclonal antibodies following recombinant AAV administration. The longest of the three has exhibited undetectable viral loads in plasma for eight years; the other two for 3-5 years (Figure 2, 10A, and 10B). All three had marked declines in their intact proviral DNA reservoir. All three also had profound declines in their anti-p27 gag antibody levels. These latter characteristics are not typically seen in patients with long-term successful antiviral therapy for their HIV infection. These results illustrate the enormous impact this approach, AAV vector delivery of monoclonal antibodies (mAbs) with potent neutralizing activity against a broad range of HIV isolates, could have on HIV infections around the world. Vector administration on one day and a subject is good for life, whether that be for prevention or treatment. The preponderance of antibody Docket No.11348-047WO1 responses to such AAV-delivered mAbs, so-called ADA (anti-drug antibodies), prevent successful long-term delivery of the desired antibodies and are a serious impediment to development for use. Mouse Studies Herein, the successful use of rapamycin for the prevention of ADA responses and for achievement of continuous AAV delivery of the mAb 3BNC117 in a mouse study is described. Five mice received rapamycin as a preventative and five mice served as controls. Rapamycin was administered from week -2 to week 11 in the test group and AAV-3BNC117 was administered at week 0 to all ten mice. The present data extends out to week 28, i.e.17 weeks (four months) after the discontinuation of rapamycin. No ADAs in 5 of 5 of the test group. Continuous delivery of the 3BNC117 out to week 28 at highly therapeutic levels of 40-60 ug / ml in 5 of 5 of the test group (Figures 5 and 6). Monkey Study A trial in five rhesus monkeys was initiated to see if the findings in mice could also be seen in monkeys. The five monkeys began receiving rapamycin at week -2. On day zero the five monkeys received AAV vectors making three potent broadly-neutralizing anti-HIV mAbs: 3BNC117, 10-1074 and PGT145. Rapamycin administration was discontinued at week 12. No ADAs were observed to 3BNC117 in 5 of 5 monkeys. No ADAs to 10-1074 in 5 of 5 monkeys. No ADAs to PGT145 in 5 of 5 monkeys (Figures 11, 12, and 13). All three mAbs have proven to be highly immunogenic in our previous studies following AAV delivery. Continuous delivery of all three monoclonal antibodies in all five monkeys was observed through the 16 weeks of measurements. (Figures 14, 15, and 16). The findings exactly parallel and extend the findings in mice. It will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the invention. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the methods disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims. Docket No.11348-047WO1 SEQUENCES 1. SEQ ID NO: 1 – C-rhesus 3BNC117 IgG-LS kappa Heavy chain MKHLWFFLLLVAAPRWVLSQVQLLQSGAAVTKPGASVRVSCEASGYNIRDYFIHWWRQ APGQGLQWVGWINPKTGQPNNPRQFQGRVSLTRHASWDFDTFSFYMDLKALRSDDTAV YFCARQRSDYWDFDVWGSGTQVTVSSASTKGPSVFPLAPSSRSTSESTAALGCLVKDYF PEPVTVSWNSGSLTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYVCNVNHKPSN TKVDKRVEIKTCGGGSKPPTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVV DVSQEDPDVKFNWYVNGAEVHHAQTKPRETQYNSTYRVVSVLTVTHQDWLNGKE YTCKVSNKALPAPIQKTISKDKGQPREPQVYTLPPSREELTKNQVSLTCLVKGFYPSDI VVEWESSGQPENTYKTTPPVLDSDGSYFLYSKLTVDKSRWQQGNVFSCSVLHEALH SHYTQKSLSLSPGK* Underline indicates a Signal Peptide, Italicize indicates a variable domain, and Bold indicates a LS mutation 2. SEQ ID NO: 2 – C-rhesus 3BNC117 IgG-LS kappa Light chain MKHLWFFLLLVAAPRWVLSDIQMTQSPSSLSASVGDTVTITCQANGYLNWYQQRRGKA PKLLIYDGSKLERGVPSRFSGRRWGQEYNLTINNLQPEDIATYFCQVYEFVVPGTRLDLKR AVAAPSVFIFPPSEDQVKSGTVSVVCLLNNFYPREASVKWKVDGVLKTGNSQESVTE QDSKDNTYSLSSTLTLSSTDYQSHNVYACEVTHQGLSSPVTKSFNRGEC* Underline indicates a Signal Peptide and Italicize indicates a variable domain 3. SEQ ID NO: 3 – C-rhesus 10-1074 IgG-LS lambda Heavy chain MKHLWFFLLLVAAPRWVLSQVQLQESGPGLVKPSETLSVTCSVSGDSMNNYYWTWIRQ SPGKGLEWIGYISDRESATYNPSLNSRVVISRDTSKNQLSLKLNSVTPADTAVYYCATARRGQ RIYGVVSFGEFFYYYSMDVWGKGTTVTVSSASTKGPSVFPLAPSSRSTSESTAALGCLVK DYFPEPVTVSWNSGSLTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYVCNVNH KPSNTKVDKRVEIKTCGGGSKPPTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVT CVVVDVSQEDPDVKFNWYVNGAEVHHAQTKPRETQYNSTYRVVSVLTVTHQDWL NGKEYTCKVSNKALPAPIQKTISKDKGQPREPQVYTLPPSREELTKNQVSLTCLVKGF YPSDIVVEWESSGQPENTYKTTPPVLDSDGSYFLYSKLTVDKSRWQQGNVFSCSVLH EALHSHYTQKSLSLSPGK* Underline indicates a Signal Peptide, Italicize indicates a variable domain, and Bold indicates a LS mutation Docket No.11348-047WO1 4. SEQ ID NO: 4 – C-rhesus 10-1074 IgG-LS lambda Light chain MKHLWFFLLLVAAPRWVLSSYVRPLSVALGETARISCGRQALGSRAVQWYQHRPGQAPI LLIYNNQDRPSGIPERFSGTPDINFGTRATLTISGVEAGDEADYYCHMWDSRSGFSWSFGG ATRLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVEVAWKADGSAVN AGVETTKPSKQSNNKYAASSYLSLTSDQWKSHKSYSCQVTHEGSTVEKTVAPAECS* Underline indicates a Signal Peptide and Italicize indicates a variable domain 5. SEQ ID NO: 5 – C-rhesus PGT145 IgG-LS-STII kappa Heavy chain MKHLWFFLLLVAAPRWVLSQVQLVQSGAEVKKPGSSVKVSCKASGNSFSNHDVHWVR QATGQGLEWMGWMSHEGDKTGLAQKFQGRVTITRDSGASTVYMELRGLTADDTAIYYCL TGSKHRLRDYFLYNEYGPNYEEWGDYLATLDVWGHGTAVTVSSASTKGPSVFPLAPSSRS TSESTAALGCLVKDYFPEPVTVSWNSGSLTSGVHTFPAVLQSSGLYSLSSVVTVPSSS LGTQTYVCNVNHKPSNTKVDKRVEIKTCGGGSKPPTCPPCPAPELLGGPSVFLFPPKP KDTLMISRTPEVTCVVVDVSQEDPDVKFNWYVNGAEVHHAQTKPRETQYNSTYRV VSVLTVTHQDWLNGKEYTCKVSNKALPAPIQKTISKDKGQPREPQVYTLPPSREELT KNQVSLTCLVKGFYPSDIVVEWESSGQPENTYKTTPPVLDSDGSYFLYSKLTVDKSR WQQGNVFSCSVLHEALHSHYTQKSLSLSPSAWSHPQFEKGK* Underline indicates a Signal Peptide, Italicize indicates a variable domain, Bold indicates a LS mutation, and Bold and Underlined indicates a Strep-tag II. 6. SEQ ID NO: 6 – C-rhesus PGT145 IgG-LS-STII kappa Light chain MKHLWFFLLLVAAPRWVLSEVVITQSPLFLPVTPGEAASLSCKCSHSLQHSTGANYLAW YLQRPGQTPRLLIHLATHRASGVPDRFSGSGSGTDFTLKISRVESDDVGTYYCMQGLHSPW TFGQGTKVEIKRAVAAPSVFIFPPSEDQVKSGTVSVVCLLNNFYPREASVKWKVDGV LKTGNSQESVTEQDSKDNTYSLSSTLTLSSTDYQSHNVYACEVTHQGLSSPVTKSFN RGEC* Underline indicates a Signal Peptide and Italicize indicates a variable domain 7. SEQ ID NO: 7 – C-human Heavy chain IgG (No LS) (Follows variable domain) ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVL QSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAP ELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKT Docket No.11348-047WO1 KPREEQYGSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREP QVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGS FFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK* 8. SEQ ID NO: 8 – C-human Light chain kappa (Follows variable domain) RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVT EQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC* 9. SEQ ID NO: 9 – C-human Light chain lambda (Follows variable domain) GQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTT PSKQSNNKYAASSYLSLTPEQWKSHKSYSCQVTHEGSTVEKTVAPTECS* 10. SEQ ID NO: 10 – Signal peptide MKHLWFFLLLVAAPRWVLS 11. SEQ ID NO: 11 – C-rhesus 3BNC117 IgG-LS kappa heavy chain variable domain QVQLLQSGAAVTKPGASVRVSCEASGYNIRDYFIHWWRQAPGQGLQWVGWINPKT GQPNNPRQFQGRVSLTRHASWDFDTFSFYMDLKALRSDDTAVYFCARQRSDYWDF DVWGSGTQVTVSS 12. SEQ ID NO: 12 – C-rhesus 3BNC117 IgG-LS kappa light chain variable domain DIQMTQSPSSLSASVGDTVTITCQANGYLNWYQQRRGKAPKLLIYDGSKLERGVPSR FSGRRWGQEYNLTINNLQPEDIATYFCQVYEFVVPGTRLDLK 13. SEQ ID NO: 13 – C-rhesus 10-1074 IgG-LS lambda heavy chain variable domain QVQLQESGPGLVKPSETLSVTCSVSGDSMNNYYWTWIRQSPGKGLEWIGYISDRESA TYNPSLNSRVVISRDTSKNQLSLKLNSVTPADTAVYYCATARRGQRIYGVVSFGEFF YYYSMDVWGKGTTVTVSS 14. SEQ ID NO: 14 – C-rhesus 10-1074 IgG-LS lambda light chain variable domain SYVRPLSVALGETARISCGRQALGSRAVQWYQHRPGQAPILLIYNNQDRPSGIPERFS GTPDINFGTRATLTISGVEAGDEADYYCHMWDSRSGFSWSFGGATRLTVL Docket No.11348-047WO1 15. SEQ ID NO : 15 – C-rhesus PGT145 IgG-LS kappa heavy chain variable domain QVQLVQSGAEVKKPGSSVKVSCKASGNSFSNHDVHWVRQATGQGLEWMGWMSHE GDKTGLAQKFQGRVTITRDSGASTVYMELRGLTADDTAIYYCLTGSKHRLRDYFLY NEYGPNYEEWGDYLATLDVWGHGTAVTVSS 16. SEQ ID NO: 16 – C-rhesus PGT145 IgG-LS kappa light chain variable domain EVVITQSPLFLPVTPGEAASLSCKCSHSLQHSTGANYLAWYLQRPGQTPRLLIHLATH RASGVPDRFSGSGSGTDFTLKISRVESDDVGTYYCMQGLHSPWTFGQGTKVEIK 17. SEQ ID NO: 17 – Strep-tag II SAWSHPQFEKGK 18. SEQ ID NO: 18 – C-rhesus heavy chain constant domain ASTKGPSVFPLAPSSRSTSESTAALGCLVKDYFPEPVTVSWNSGSLTSGVHTFPAVLQ SSGLYSLSSVVTVPSSSLGTQTYVCNVNHKPSNTKVDKRVEIKTCGGGSKPPTCPPCP APELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPDVKFNWYVNGAEVHH AQTKPRETQYNSTYRVVSVLTVTHQDWLNGKEYTCKVSNKALPAPIQKTISKDKGQ PREPQVYTLPPSREELTKNQVSLTCLVKGFYPSDIVVEWESSGQPENTYKTTPPVLDS DGSYFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 19. SEQ ID NO: 19 – C-rhesus heavy chain constant domain with M428L and N434S mutations ASTKGPSVFPLAPSSRSTSESTAALGCLVKDYFPEPVTVSWNSGSLTSGVHTFPAVLQ SSGLYSLSSVVTVPSSSLGTQTYVCNVNHKPSNTKVDKRVEIKTCGGGSKPPTCPPCP APELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPDVKFNWYVNGAEVHH AQTKPRETQYNSTYRVVSVLTVTHQDWLNGKEYTCKVSNKALPAPIQKTISKDKGQ PREPQVYTLPPSREELTKNQVSLTCLVKGFYPSDIVVEWESSGQPENTYKTTPPVLDS DGSYFLYSKLTVDKSRWQQGNVFSCSVLHEALHSHYTQKSLSLSPGK Bold indicates an LS mutation. 20. SEQ ID NO: 20 – C-rhesus heavy chain constant domain with Strep-tagII ASTKGPSVFPLAPSSRSTSESTAALGCLVKDYFPEPVTVSWNSGSLTSGVHTFPAVLQ SSGLYSLSSVVTVPSSSLGTQTYVCNVNHKPSNTKVDKRVEIKTCGGGSKPPTCPPCP Docket No.11348-047WO1 APELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPDVKFNWYVNGAEVHH AQTKPRETQYNSTYRVVSVLTVTHQDWLNGKEYTCKVSNKALPAPIQKTISKDKGQ PREPQVYTLPPSREELTKNQVSLTCLVKGFYPSDIVVEWESSGQPENTYKTTPPVLDS DGSYFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPSAWSHPQFEK GK Bold and Underlined indicates a Strep-tag II. 21. SEQ ID NO: 21 – C-rhesus heavy chain constant domain with M428L and N434S mutations and Strep-tag II ASTKGPSVFPLAPSSRSTSESTAALGCLVKDYFPEPVTVSWNSGSLTSGVHTFPAVLQ SSGLYSLSSVVTVPSSSLGTQTYVCNVNHKPSNTKVDKRVEIKTCGGGSKPPTCPPCP APELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPDVKFNWYVNGAEVHH AQTKPRETQYNSTYRVVSVLTVTHQDWLNGKEYTCKVSNKALPAPIQKTISKDKGQ PREPQVYTLPPSREELTKNQVSLTCLVKGFYPSDIVVEWESSGQPENTYKTTPPVLDS DGSYFLYSKLTVDKSRWQQGNVFSCSVLHEALHSHYTQKSLSLSPSAWSHPQFEKG K Bold indicates an LS mutation, and Bold and Underlined indicates a Strep-tag II. 22. SEQ ID NO: 22 – C-rhesus kappa light chain constant domain RAVAAPSVFIFPPSEDQVKSGTVSVVCLLNNFYPREASVKWKVDGVLKTGNSQESVT EQDSKDNTYSLSSTLTLSSTDYQSHNVYACEVTHQGLSSPVTKSFNRGEC 23. SEQ ID NO: 23 – C-rhesus lambda light chain constant domain GQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVEVAWKADGSAVNAGVETTK PSKQSNNKYAASSYLSLTSDQWKSHKSYSCQVTHEGSTVEKTVAPAECS 24. SEQ ID NO: 24 - C-rhesus 3BNC117 IgG-LS kappa heavy chain variable domain CDR1 GYNIRDYF 25. SEQ ID NO: 25 - C-rhesus 3BNC117 IgG-LS kappa heavy chain variable domain CDR2 INPKTGQP Docket No.11348-047WO1 26. SEQ ID NO: 26 - C-rhesus 3BNC117 IgG-LS kappa heavy chain variable domain CDR3 ARQRSDYWDFDV 27. SEQ ID NO: 27 - C-rhesus 3BNC117 IgG-LS kappa light chain variable domain CDR1 NGY 28. SEQ ID NO: 28 - C-rhesus 3BNC117 IgG-LS kappa light chain variable domain CDR2 DGS 29. SEQ ID NO: 29 - C-rhesus 3BNC117 IgG-LS kappa light chain variable domain CDR3 QVYEF 30. SEQ ID NO: 30 - C-rhesus 10-1074 IgG-LS lambda heavy chain variable domain CDR1 GDSMNNYY 31. SEQ ID NO: 31 - C-rhesus 10-1074 IgG-LS lambda heavy chain variable domain CDR2 ISDRESA 32. SEQ ID NO: 32 - C-rhesus 10-1074 IgG-LS lambda heavy chain variable domain CDR3 ATARRGQRIYGVVSFGEFFYYYSMDV 33. SEQ ID NO: 33 - C-rhesus 10-1074 IgG-LS lambda light chain variable domain CDR1 ALGSRA Docket No.11348-047WO1 34. SEQ ID NO: 34 - C-rhesus 10-1074 IgG-LS lambda light chain variable domain CDR2 NNQ 35. SEQ ID NO: 35 - C-rhesus 10-1074 IgG-LS lambda light chain variable domain CDR3 HMWDSRSGFSWS 36. SEQ ID NO: 36 - C-rhesus PGT145 IgG-LS kappa heavy chain variable domain CDR1 GNSFSNHD 37. SEQ ID NO: 37 - C-rhesus PGT145 IgG-LS kappa heavy chain variable domain CDR2 MSHEGDKT 38. SEQ ID NO: 38 - C-rhesus PGT145 IgG-LS kappa heavy chain variable domain CDR3 LTGSKHRLRDYFLYNEYGPNYEE 39. SEQ ID NO: 39 - C-rhesus PGT145 IgG-LS kappa light chain variable domain CDR1 HSLQHSTGANY 40. SEQ ID NO: 40 - C-rhesus PGT145 IgG-LS kappa light chain variable domain CDR2 LAT 41. SEQ ID NO: 41 - C-rhesus PGT145 IgG-LS kappa light chain variable domain CDR3 MQGLHSPWT

Claims

Docket No.11348-047WO1 CLAIMS What is claimed is:

1. A method of treating or preventing a Human Immunodeficiency Virus (HIV), a Hepatitis B Virus (HBV), an influenza virus, or a respiratory syncytial virus (RSV) infection in a subject, the method comprising administering a therapeutic regimen comprising: a. rapamycin, or variants thereof, and b. a viral vector encoding a broadly neutralizing antibody.

2. The method of claim 1, wherein the broadly neutralizing antibody comprises 3BNC117, 10-1074, or PGT145.

3. The method of claim 1 or 2, wherein the viral vector comprises an adeno-associated viral (AAV) vector.

4. The method of any one of claims 1-3, wherein rapamycin, or variants thereof, is administered 1, 2, 3, 4, or 5 days prior to administering the viral vector.

5. The method of any one of claims 1-4, wherein rapamycin, or variants thereof, is further administered 8 weeks or more following administering the viral vector.

6. The method of any one of claims 1-5, wherein rapamycin, or variant thereof, is administered one, two, three, four, five, six, or seven times per week.

7. The method of any one of claims 1-6, wherein rapamycin, or variants thereof, is administered by an intraperitoneal (i.p.) injection.

8. The method of any one of claims 1-7, wherein the therapeutic regimen comprises administering one or more viral vectors encoding a 3BNC117 neutralizing antibody, a 10-1074 neutralizing antibody, or a PGT145 neutralizing antibody.

9. The method of claim 8, wherein the one or more viral vectors are individually administered.Docket No.11348-047WO1 10. The method of any one of claims 1-9, wherein the viral vector is administered by an intramuscular (i.m.) injection.

11. The method of any one of claims 1-10, wherein the method expresses the neutralizing antibodies for more than 5 weeks.

12. The method of any one of claims 1-11, wherein the method expresses the neutralizing antibodies for more than 7 years.

13. The method of any one of claims 1-12, wherein the method expresses the neutralizing antibodies during a remainder of the subject’s life.

14. The method of any one of claims 3-13, wherein the AAV vector comprises an AAV9 serotype.

15. The method of any one of claims 1-14, wherein the therapeutic regimen is administered in combination with an antiviral agent selected from a nucleoside reverse transcriptase inhibitor, a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor, a fusion inhibitor, a CCR5 antagonist, an integrase strand transfer inhibitor, an attachment inhibitor, a post-attachment inhibitor, a capsid inhibitor, a CYP3A inhibitor, and combinations thereof.

16. The method of any one of claims 1-15, wherein the method decreases a viral load in the subject relative to an untreated subject with a viral infection.

17. A method of preventing or reducing an anti-drug antibody (ADA) response in a subject with a disease, wherein rapamycin is administered to the subject prior to administration of at least one viral vector-delivered antibody or antibody-like molecule.

18. The method of claim 17, wherein the at least one viral vector-delivered antibody or antibody-like molecule comprises two or more antibody combinations.

19. The method of claim 17 or 18, wherein the at least one viral vector-delivered antibody or antibody-like molecule comprises a monoclonal antibody (mAb).Docket No.11348-047WO1 20. The method of any one of claims 17-19, wherein the at least one viral vector-delivered antibody or antibody-like molecule comprises an adeno-associated viral (AAV) vector.

21. The method of claim 20, wherein the AAV vector comprises an AAV9 serotype.

22. The method of any one of claims 17-21, wherein the disease comprises an infectious disease.

23. The method of claim 22, wherein the infectious disease comprises acquired immune deficiency syndrome / human immunodeficiency virus (AIDS / HIV), malaria, hepatitis A, hepatitis B, hepatitis C, influenza, or variants thereof.

24. The method of any one of claims 17-23, wherein the ADA response comprises an immune response wherein the subject generates an antibody targeting the at least one viral vector-delivered antibody or antibody-like molecule.

25. The method of any one of claims 1-24, wherein the subject is a human.

26. A pharmaceutical kit comprising rapamycin, or variants thereof, and one or more viral vectors encoding a broadly neutralizing antibody selected from 3BNC117, 10-1074, or PGT145.

27. The pharmaceutical kit of claim 26, wherein rapamycin, or variants thereof, is in a pharmaceutically acceptable carrier selected from an excipient, a diluent, a salt, a buffer, a stabilizer, a preservative, a lipid, an emulsion, and a nanoparticle.

28. The pharmaceutical kit of claim 26 or 27, wherein the viral vector is in a pharmaceutically acceptable carrier selected from an excipient, a diluent, a salt, a buffer, a stabilizer, a preservative, a lipid, an emulsion, and a nanoparticle.

29. The pharmaceutical kit of any one of claims 26-28, wherein the viral vector comprises an adeno-associated viral (AAV) vector.Docket No.11348-047WO1 30. The pharmaceutical kit of claim 29, wherein the AAV vector comprises an AAV9 serotype.

31. The pharmaceutical kit of any one of claims 26-30, wherein said kit is combined with an antiviral agent selected from a nucleoside reverse transcriptase inhibitor, a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor, a fusion inhibitor, a CCR5 antagonist, an integrase strand transfer inhibitor, an attachment inhibitor, a post-attachment inhibitor, a capsid inhibitor, a CYP3A inhibitor, and combinations thereof.

32. The pharmaceutical kit of any one of claims 26-31, wherein said kit treats or prevents an infection in a subject.

33. The pharmaceutical kit of any one of claims 26-32, wherein said kit reduces viral loads in the subject with the infection.

34. The pharmaceutical kit of any one of claims 26-33, wherein said kit reduces viral loads in a subject with Acquired Immunodeficiency Syndrome (AIDS).

35. The pharmaceutical kit of any one of claims 26-34, wherein the subject is a human.

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