Molecules enhancing dermal delivery of influenza vaccines
The present invention relates to dermal vaccine formulations, designed for targeted delivery of an immunogenic composition to a dermal compartment of skin including the intradermal and epidermal compartments. The dermal vaccine formulations of the invention comprise an antigenic or immunogenic agent, and at least one molecule, e.g., a chemical agent, which enhances the presentation and/or availability of the antigenic or immunogenic agent to the immune cells of the intradermal compartment or epidermal compartment resulting in an enhanced immune response. The dermal vaccine formulations of the invention have enhanced efficacy as the antigenic or immunogenic agent is delivered to the intradermal compartment or epidermal compartment with enhanced presentation and/or availability to the immune cells that reside therein. The enhanced efficacy of the dermal vaccine formulations results in a therapeutically effective immune response after a single intradermal or epidermal dose, with lower doses of antigenic or immunogenic agent than conventionally used, and without the need for booster immunizations.
1. An immunogenic composition, comprising an immunogenic or antigenic agent and a cocktail of at least two agents, wherein the first agent is selected from the group consisting of poloxamer 407 , poloxamer 188 , poloxamer 338 , poloxamer 237 , poloxamer 231 , poloxamer 282 , poloxamer 331 , poloxamer 401 , poloxamer 402 , and poloxamer 461 , and the second agent is urea, so that the cocktail enhances the immune response against the antigenic or immunogenic agent upon administration of the immunogenic composition to a subject.
2. The immunogenic composition of claim 1 , wherein the concentration of the first agent used in the composition is from about 1 % w/v to about 25% w/v of the composition.
3. The immunogenic composition of claim 1 , wherein the concentration of the first agent used in the composition is from about 3% w/v to about 15% w/v of the composition.
4. The immunogenic composition of claim 1 , wherein the concentration of the first agent used in the composition is from about 5% w/v to about 10% w/v of the composition.
5. The immunogenic composition of claim 1 , wherein the concentration of urea used in the composition is from about 0.01% w/v to about 10% w/v of the composition.
6. The immunogenic composition of claim 1 , wherein the concentration of urea used in the composition is from about 0.1% w/v to about 5% w/v of the composition.
7. The immunogenic composition of claim 1 , wherein the concentration of urea used in the composition is from about 0.2% w/v to about 1% w/v of the composition.
8. The immunogenic composition of claim 1 , wherein the concentration of the first agent used in the composition is about 5% w/v and the concentration of urea used in the composition is about 0.2% w/v.
9. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 407 .
10. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 188 .
11. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 338 .
12. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 237 .
13. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 231 .
14. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 282 .
15. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 331 .
16. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 401 .
17. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 402 .
18. The immunogenic composition of claim 1 , wherein the first agent is poloxamer 461 .
19. An immunogenic composition comprising an immunogenic or antigenic agent, wherein the immunogenic or antigenic agent is a peptide, polypeptide, polypeptide fragment, or polysaccharide, and a cocktail of at least two agents, wherein the first agent is poloxamer 407 and the second agent is urea.
20. The immunogenic composition of claim 19 , wherein the concentration of poloxamer 407 used in the composition is from about 1% w/v to about 25% w/v of the composition.
21. The immunogenic composition of claim 19 , wherein the concentration of poloxamer 407 used in the composition is from about 3% w/v to about 15% w/v of the composition.
22. The immunogenic composition of claim 19 , wherein the concentration of poloxamer 407 used in the composition is from about 5% w/v to about 10% w/v of the composition.
23. The immunogenic composition of claim 19 , wherein the concentration of urea used in the composition is from about 0.01% w/v to about 10% w/v of the composition.
24. The immunogenic composition of claim 19 , wherein the concentration of urea used in the composition is from about 0.1% w/v to about 5% w/v of the composition.
25. The immunogenic composition of claim 19 , wherein the concentration of urea used in the composition is from about 0.2% w/v to about 1 % w/v of the composition.
26. The immunogenic composition of claim 19 , wherein the immunogenic or antigenic agent is a peptide.
27. The immunogenic composition of claim 19 , wherein the immunogenic or antigenic agent is a polypeptide.
28. The immunogenic composition of claim 19 , wherein the immunogenic or antigenic agent is a polypeptide fragment.
29. The immunogenic composition of claim 19 , wherein the immunogenic or antigenic agent is a polysaccharide.