Vaccine compositions and methods of use

a technology of compositions and vaccines, applied in the field of immunology, can solve the problems of difficult induction of immunodeficiency virus against proteins, difficulty in identifying distinct subtypes of viruses, and approaches that do not provide cross-reactivity to distinct subtypes of viruses, and achieve novel and cost-effective approaches, improved protection and cure, and strong increases in humoral and cell-mediated responses.

Inactive Publication Date: 2015-09-10
PDS BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0020]The vaccine compositions and methods according to the present disclosure provide several advantages compared to other compositions and methods in the art. First, the vaccine compositions can induce broadly cross-protective immunity to different subtypes of influenza, as well as development of a universal influenza vaccine that can provide protection against multiple influenza strains.
[0021]Second, the vaccine compositions demonstrate strong increases in both humoral and cell-mediated responses and can provide a simple adjuvant platform for developing a new generation of simple vaccines that do not require adjuvant com...

Problems solved by technology

As described above, immunity has been difficult to induce against the proteins found in emerging strains of influenza, such as those in H5N1 viruses that cause avian flu.
It is commonly believed that difficulties occur partly because of the existence of memory cells that can recognize annual, but not new, viral strains.
However, these approaches do not provide cross-reactivity to distinct subtypes of the virus.
Several other infections, such as hepatitis, HIV, and malaria, for example, exist for which antibodies provide insufficient protection.
Aluminum salts, however, do not directly induce signaling through TLRs and do not stimulate IL-12 production by DCs.
As described above, although some adjuvants such as the cationic lipids and MPL can elicit T-cell responses when formulated with peptides, the use of peptide fragments rather than whole a...

Method used

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  • Vaccine compositions and methods of use
  • Vaccine compositions and methods of use
  • Vaccine compositions and methods of use

Examples

Experimental program
Comparison scheme
Effect test

example 2

Evaluation of the Protective Potency of a Cationic Lipid-Based Influenza Vaccine: Protective Hemagglutination Inhibition Assay Against a / Perth / 16 / 2009 (H3N2)

[0389]C57BL / 6J mice were injected subcutaneously in the shaved flank with 100 μl to deliver a final dose of 3 μg or 0.6 μg of the antigen in either PBS, 4 mM R-DOTAP or 2 mM R-DOTAP. The mice were injected on day 0, then again with the identical formulation on day 21. Tail vein bleeds were performed on days 14 and 35.

[0390]Serum was stored frozen at −80° C. prior to testing. Samples were coded with respect to the treatment groups. A Hemagglutination inhibition assay was performed against the viruses A / Perth / 16 / 2009 (H3N2) to quantify the anti-influenza antibody induction and resulting protective efficacy of the vaccines.

[0391]Four mice were tested per group:

1. Naïve

2. 3 ug+PBS

3. 3 ug+4 mM R-DOTAP

4. 3 ug+2 mM R-DOTAP

5. 0.6 ug+PBS

6. 0.6 ug+4 mM R-DOTAP

7. 0.6 ug+2 mM R-DOTAP

[0392]The results are shown in FIG. 1. After the first inj...

example 3

Evaluation of the Protective Potency of a Cationic Lipid-Based Influenza Vaccine: Protective Hemagglutination Inhibition Assay Against Pandemic Influenza Strain A / California / 07 / 2009 (H1N1)

[0393]C57BL / 6J mice were injected subcutaneously in the shaved flank with 100 μl to deliver a final dose of 3 μg or 0.6 μg of the antigen in either PBS, 4 mM R-DOTAP or 2 mM R-DOTAP. The mice were injected on day 0, then again with the identical formulation on day 21. Tail vein bleeds were performed on days 14 and 35.

[0394]Serum was stored frozen at −80° C. prior to testing. Samples were coded with respect to the treatment groups. A Hemagglutination inhibition assay was performed against the virus A / California / 07 / 2009 (H1N1) to quantify the antibody induction and protective efficacy of the vaccines.

[0395]Four mice were tested per group:

1. Naïve

2. 3 ug+PBS

3. 3 ug+4 mM R-DOTAP

4. 3 ug+2 mM R-DOTAP

5. 0.6 ug+PBS

6. 0.6 ug+4 mM R-DOTAP

7. 0.6 ug+2 mM R-DOTAP

[0396]The results are shown in FIG. 2. After the ...

example 4

Evaluation of the Protective Potency of a Cationic Lipid-Based Influenza Vaccine: Protective Hemagglutination Inhibition Assay Against Influenza Strain B Brisbane

[0397]C57BL / 6J mice were injected subcutaneously in the shaved flank with 100 μl to deliver a final dose of 3 μg or 0.6 μg of the antigen in either PBS, 4 mM R-DOTAP or 2 mM R-DOTAP. The mice were injected on day 0, then again with the identical formulation on day 21. Tail vein bleeds were performed on days 14 and 35.

[0398]Serum was stored frozen at −80° C. prior to testing. Samples were coded with respect to the treatment groups. A Hemagglutination inhibition assay was performed against the virus B Brisbane to quantify the antibody induction and protective efficacy of the vaccines.

[0399]Four mice were tested per group:

1. Naïve

2. 3 ug+PBS

3. 3 ug+4 mM R-DOTAP

4. 3 ug+2 mM R-DOTAP

5. 0.6 ug+PBS

6. 0.6 ug+4 mM R-DOTAP

7. 0.6 ug+2 mM R-DOTAP

[0400]The results are shown in FIG. 3. After the first injection (day 14 bleed), little diff...

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Abstract

The present disclosure provides vaccine compositions comprising at least one adjuvant and at least one antigen, wherein the adjuvant is a cationic lipid. The disclosure also provides methods of treating a disease in a mammal, methods of preventing a disease in a mammal, and methods of effecting antigen cross presentation to induce a humoral immune response and a cellular immune response in a mammal utilizing the vaccine compositions. Cross presentation of various antigens can be achieved by formulating the specific antigens with cationic lipids possessing adjuvant properties.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit under 35 USC §119(e) of U.S. Provisional Application Ser. No. 61 / 703,814, filed on Sep. 21, 2012, the entire disclosure of which is incorporated herein by reference.TECHNICAL FIELD[0002]Despite an increasing amount of research and interest in the field of immunology, there is currently a lack of vaccines that are adequately effective against various infectious pathogens or diseases such as malaria, HIV, hepatitis C, influenza, and tuberculosis. For example, current influenza vaccines induce antibodies against two main surface proteins from the virus, hemagglutinin and neuraminidase. Thus, current influenza vaccines only effectively protect against infection by strains of the virus that express versions of these proteins present in the vaccine. However, these two surface proteins frequently change as a consequence of mutations and re-assortment. Accordingly, influenza vaccines must be reformulated each y...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K39/145A61K39/00A61K39/12A61K39/02
CPCA61K39/39A61K39/12A61K39/02A61K2039/55511A61K39/145A61K39/0005C12N2760/16034A61K39/0002A61K2039/55555C12N2760/16134C12N2760/16234A61K2039/70A61P31/04A61P31/10A61P31/12A61P31/16A61P37/00Y02A50/30
Inventor BEDU-ADDO, FRANKJACOBSON, ERICJOHNSON, KENYA
Owner PDS BIOTECH
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