QS-21 and IL-12 as an adjuvant combination
View Patent ↗Adjuvant compositions comprising an effective amount IL-12 and QS-21 are disclosed. Immunogenic, vaccine and pharmaceutical compositions comprising a mixture of antigen and an adjuvant composition comprising an effective amount of IL-12 and QS-21 are also disclosed. These compositions elicit functional cell-mediated and humoral immune responses against at least one antigen. Methods of using the disclosed compositions are also disclosed.
1. An immunogenic composition comprising:
(a) a bacterial or viral antigen for which an increase in immunogenicity is desired, wherein said bacterial antigen is not lipidated,
(b) a pharmaceutically acceptable vehicle, and
(c) an adjuvant formulation that consists of a synergistic combination of 0.8 μg of QS-21 and 0.01 μg to 1.0 μg of IL-12.
2. The immunogenic composition of claim 1 , wherein said IL-12 is recombinant human IL-12.
3. The immunogenic composition of claim 1 , wherein the amount of IL-12 in the adjuvant formulation is 0.01 μg of IL-12.
4. The immunogenic composition of claim 1 , wherein the amount of IL-12 in the adjuvant formulation is 0.05 μg of IL-12.
5. The immunogenic composition of claim 1 , wherein the amount of IL-12 in the adjuvant formulation is 0.1 μg of IL-12.
6. The immunogenic composition of claim 1 , wherein said antigen is a bacterial protein.
7. The immunogenic composition according to claim 6 , wherein said antigen is P4 protein from non-typable Haemophilus influenzae.
8. The immunogenic composition of claim 1 , wherein said antigen is a viral protein.
9. The immunogenic composition according to claim 8 , wherein said antigen is respiratory syncytial virus F protein.
10. The immunogenic composition of claim 1 , wherein the amount of IL-12 in the adjuvant formulation is 0.5 μg of IL-12.
11. The immunogenic composition of claim 1 , wherein the amount of IL-12 in the adjuvant formulation is 1.0 μg of IL-12.
12. A method of eliciting an immune response to a bacterial or viral antigen for which an increase in immunogenicity is desired, wherein said bacterial antigen is not lipidated, comprising administering to a vertebrate a composition comprising:
(a) said antigen,
(b) a pharmaceutically acceptable vehicle, and
(c) an adjuvant formulation that consists of a synergistic combination of 0.8 μg of QS-21 and 0.01 μg to 1.0 μg of IL-12.
13. The method of claim 12 , wherein said IL-12 is recombinant human IL-12.
14. The method of claim 12 , wherein the amount of IL-12 in the adjuvant formulation is 0.01 μg of IL-12.
15. The method of claim 12 , wherein said antigen is a bacterial protein.
16. The method according to claim 15 , wherein said antigen is P4 protein from non-typable Haemophilus influenzae.
17. The method of claim 12 , wherein said antigen is a viral protein.
18. The method according to claim 17 , wherein said antigen is respiratory syncytial virus F protein.
19. The method of claim 1 , wherein the amount of IL-12 in the adjuvant formulation is 0.5 μg of IL-12.
20. The method of claim 12 , wherein the amount of IL-12 in the adjuvant formulation is 1.0 μg of IL-12.