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Novel method and compositions

A vaccine composition, mammalian technology, applied in the field of novel and composition, which can solve the problem of impossibility, impossibility, cumbersomeness of boosting viral vector components

Inactive Publication Date: 2010-03-17
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] However, while a "prime-boost" vaccine strategy may generally produce a stronger or more balanced response, the need for more than one, and certainly more than two, vaccinations may be burdensome or even impossible, especially in developing countries of the extensive immunization program
[0015] Furthermore, as already mentioned above, it is usually not possible to boost viral vector components, since immunity against the vector itself may arise

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0297] Immunization with adenovirus component (Pan7GRN) and protein component (F4 / adjuvant B) alone or with adenovirus Immunogenicity studies in mice immunized with formulations co-formulated with viral and protein components

[0298] The mouse strain used was CB6F1 with 3 mice per time point. For immunizations with F4 / Adjuvant B (P), 1 / 10 the human dose, ie, 9 μg F4 protein / 50 μl Adjuvant B, was injected. For immunizations with Pan7GRN (A) 10×10 8 Virions / 50 μl saline (0.9% NaCl in water for injection). Pan7GRN chimpanzee adenovirus carries genes encoding Gag(G), RT(R) and Nef(N).

[0299] The vaccination schedule is as follows:

[0300] group

Day 0

Day 21

Day 42

Day 63

1

-

-

F4 / adj B

F4 / adj B

2

-

-

Pan7GRN

Pan7GRN

3

F4 / adj B

F4 / adj B

Pan7GRN

Pan7GRN

4

Pan7GRN

Pan7GRN

F4 / adj B

F4 / adj B

5

-

-

-

F4...

Embodiment 2

[0335] After immunization with Pan7GRN adenovirus co-formulated with F4 protein / adjuvant B Immunogenicity studies in mice

[0336] The mouse strain used was CB6F1, with 9 mice per group. F4 protein (injected 1 / 10 human dose, i.e., 9 μg) with 10×10 in 50 μL Adjuvant B or its dilution (1 / 2, 1 / 41 / 10) 8 Mice were immunized once with a co-formulation of each Pan7GRN virion. CD4 and CD8 cell responses against Nef, p17, p24 or RT peptide pools (3 pools of 3 spleens per group) were determined 21 days after immunization.

[0337] Do the following readout:

[0338] cellular response ( Figure 9 ):

[0339] - Measured by restimulation of splenocytes overnight with p24, RT, Nef or p17 peptide pools followed by surface and intracellular cytokine staining followed by flow cytometry analysis. Splenocytes were collected for analysis (3 pools of 3 spleens per group).

[0340] result:

[0341] Figure 9 The results shown in represent the cellular responses observed after restimulati...

Embodiment 3

[0352] After immunization with Pan7GRN or sequential immunization with F4 / adjuvant B or adenovirus and protein component one Immunogenicity studies in New Zealand white rabbits immunized with co-formulated preparations

[0353] For immunizations with F4 / Adjuvant B, a human dose, ie, 90 μg F4 protein / 500 μL Adjuvant B, was injected. For immunizations with Pan7GRN, use 10 × 10 10 or 10×10 12 Viral particles / 500 μL saline. For immunizations with formulations co-formulated with adenovirus and protein components, use 90 μg F4 protein per 500 μL Adjuvant B, 10×10 11 Pan7GRN virions.

[0354] The vaccination schedule is as follows:

[0355] Group

do not

Day 0

Day 14

Day 126

1

F4 / adj B

F4 / adj B

F4 / adj B

2

Pan7GRN 10^10

Pan7GRN 10^10

3

Pan7GRN 10^12

Pan7GRN 10^12

4

F4 / adj B / Pan7GRN

10^11

F4 / adj B / Pan7GRN

10^11

F4 / adj B / Pan7GRN

10^11

...

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PUM

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Abstract

The present invention relates to, inter alia, a method of raising an immune response against a pathogen which comprises administering (i) one or more first immunogenic polypeptides derived from said pathogen; (ii) one or more adenoviral vectors comprising one or more heterologous polynucleotides encoding one or more second immunogenic polypeptides derived from said pathogen; and (iii) an adjuvant;wherein the one or more first immunogenic polypeptides, the one or more adenoviral vectors and the adjuvant are administered concomitantly. The invention also relates to vaccines, pharmaceutical compositions, kits and uses employing said polypeptides, adenoviral vectors and adjuvants.

Description

technical field [0001] The present invention relates to novel vaccine compositions and their use for stimulating immune responses in mammals, especially humans, in particular for preventing and treating infections caused by pathogens. In particular, the present invention relates to compositions capable of inducing CD4+ and CD8+ T cell responses as well as antibody responses in a subject independent of complex prime-boost regimens. Background technique [0002] Inactivated whole organisms have been successfully used for vaccination since the late nineteenth century. More recently, vaccines involving administration of extracts, subunits, toxoids and capsular polysaccharides have been employed. Since genetic engineering techniques became available, the use of recombinant proteins has become a popular strategy that eliminates some of the risks associated with the use of purified proteins from natural sources. [0003] Early vaccine approaches were based on the administration o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K14/16C07K14/445C12N15/861A61K39/00
CPCC12N2740/16222A61K2039/55572A61K2039/55555A61K2039/55577A61K39/015A61K2039/545A61K39/21C12N2710/10343A61K2039/53C07K14/005C12N2740/16322A61K2039/55566A61K39/12A61P1/16A61P31/04A61P31/06A61P31/12A61P31/14A61P31/18A61P31/20A61P31/22A61P33/00A61P33/02A61P33/06A61P37/00A61P37/04A61P43/00C07K14/35C07K14/445Y02A50/30A61K39/00A61K39/235A61K39/39
Inventor G·H·沃斯
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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