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Immunogenic influenza composition

A composition and immunogen technology, applied in the directions of drug combinations, vaccines, microorganisms, etc., can solve the problems of reduced efficacy, inability to respond to late-occurring and drifting strains, and vaccines that cannot be used in children, and achieve the effect of saving lives.

Inactive Publication Date: 2011-04-13
BIOLOGICAL MIMETICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Annual production is risky because of the need to find the right virus composition;
[0018] (3) Inability to respond to late emerging and drifting strains, such as A / Sydney / 5 / 97 in the late 1990s, or to a potentially epidemic strain , such as the H5N1 virus that appeared in Hong Kong in 1997;
[0019] (4) Protection from existing whole or split influenza vaccines is short-lived and less effective as antigenic variation occurs among circulating strains of influenza genetic change
The hemagglutinin of influenza virus produced in eggs may be altered compared to influenza virus originally isolated from infected individuals (Oxford et al., J. Gen. Virol. 72:185-189, 1989; and Rocha et al., J. Gen. Virol .74:2513-2518,1993), which reduces the potential efficacy of the vaccine;
[0020] (5) vaccines produced in eggs have side effects in persons with egg allergies; and
[0022]Thus, currently licensed influenza vaccines fail to: (1) induce recurrent antigenic variants that can neutralize common annual epidemics , and subtypes and recombinant viruses; (2) induce potent immune responses in the elderly; and (3) have limited applicability due to side effects, eg, some vaccines cannot be used in children

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0097] Active ingredients that can be encapsulated in microcapsules are prepared, for example, by conventional techniques, in colloidal drug delivery systems (e.g. liposomes, albumin microspheres, microemulsions, nanoparticles and nanocapsules) or in macroemulsions ( macroemulsions), for example, hydroxymethylcellulose or gelatin microcapsules and poly(methyl methacrylate) microcapsules, respectively, are applied for interfacial polymerization. This technique is disclosed in Remington's Pharmaceutical Sciences, 16th edition, A. Osal, Ed. (1980).

[0098] Pulmonary administration can be achieved, for example, by the use of inhalers or nebulizers, and formulations with nebulizers. The composition of interest can also be administered to the lungs of a patient in the form of a dry powder composition, see, eg, US Patent 6,514,496.

[0099] It may be desirable to administer a therapeutic product or composition of the present invention locally to the area in need of treatment; this ...

Embodiment 1

[0129] Eight immunosuppressive and refocused Wyoming strain (H3N2) derived hemagglutinin genes were designed and engineered as described above. For example, nucleotides were replaced by site-directed mutagenesis to introduce N-linked sequence peptides causing complex carbohydrate modifications, and / or amino acid deletions and / or charge changes into the five main immunogens containing IDNPE. And drastic changes in the site.

[0130] The introduction of N-linked sequences was used to maximize the immunosuppressive effect caused by each change, especially at more antigenic sites, while reducing the number of wild-type amino acid changes required to suppress and minimizing Any effect on the conformational complexity of the glycoprotein and the receptor-binding region. In some cases, only 3 amino acid changes were required. Antigenic site B (187-196) binds the IDNPE of both B cells and CD4 helper T cells.

[0131] To expedite research, both DNA and protein subunit vaccines were ...

Embodiment 2

[0142] The safety, toxicity, and efficacy of recombinant immunogens are evaluated by the procedures at 21 CFR610, which include: (i) basic safety studies, and (ii) acute and chronic toxicity studies.

[0143] Immunogenicity data are obtained from acceptable animal models (eg, guinea pigs, rats, ferrets, or cotton rats) that respond well to human influenza vaccines. The studies included dose-related and evaluation of immune responses using different doses of the vaccine containing the strain used in the final product. Immunogenicity studies in corresponding animal models are used to demonstrate consistency of production, especially during the validation phase of the manufacturing process for novel influenza viruses. Suitable non-clinical endpoints selected for animal studies include death, weight loss, viral shedding rates, clinical symptoms such as fever, ocular and nasal discharge, and the like.

[0144] Inoculate groups of ferrets or other appropriate groups of animals intr...

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PUM

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Abstract

Novel compositions useful as influenza immunogens are provided The compositions enable a host response to immunogen sites normally not recognized by a host.

Description

Background technique [0001] The existing stable of licensed vaccines for human and livestock applications are generally successful against so-called "type 1" pathogens. Type 1 pathogens (eg, measles, mumps, and rubella viruses) are those that typically: (1) infect or cause most severe disease in infants, young children, adolescents, and young adults; (2) carry relatively stable microbial genomes; (3) have Natural disease history that induces spontaneous recovery; and (4) induction of persistent memory, associated with polyclonal and polyepitope antigen recognition. [0002] In contrast, type 2 pathogens such as influenza virus, HIV-1, Plasmodium, mycoplasma such as those that cause tuberculosis, trypanosomes, schistosomes, Leishmania, Anaplasma, enteroviruses Enteroviruses, Astroviruses, Rhinoviruses, Norwalk virus, toxigenic / pathogenic Escherichia coli, Neisseria, Streptomyces, nontypeable Haemophilus Influenza virus, hepatitis C virus, cancer cells, etc., differ markedly i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/145A61P31/16
CPCA61K2039/5252C12N2760/16034A61K2039/525A61K2039/5258A61K39/145A61K39/12A61K2039/53A61K2039/55566A61P31/16A61P37/04C12N2760/16134
Inventor P·L·奈良G·J·托宾G·林
Owner BIOLOGICAL MIMETICS
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