Immunogenic compositions and uses thereof
Immunogenic compositions comprising viral vectors and surfactants are provided. Methods for administration and preparation of such compositions are also provided.
1. An immunogenic composition comprising an antigen, said antigen formulated in a solid amorphous carrier comprising: (i) PMAL-C16; (ii) from about 0.1% to 10% of a zwitterionic surfactant having a lipid group with a chain length of 13-30 carbon atoms; or (iii) from about 0.1 to 50 mg/ml of a zwitterionic surfactant having a lipid group with a chain length of 13-30 carbon atoms.
2. The composition of claim 1 , wherein the substantially solid amorphous carrier comprises less than 5% water.
3. The composition of claim 1 , further comprising a stabilizing agent, wherein the stabilizing agent is carbohydrate stabilizer selected from the groups consisting of sucrose, mannitol, melezitose, trehalose or mixture thereof.
4. The composition of claim 1 , further comprising a plasticizer agent, wherein the plasticizer agent is a gum selected from the group consisting of guar gum, enugreek gum, locust bean gum, Gum arabic, karaya gum, Carrageenan, Pullulan, agar-agar, or an alginate.
5. The composition of claim 1 , wherein the carrier comprises PMAL-C16.
6. The composition of claim 1 , wherein the antigen is a virus.
7. The composition of claim 1 , wherein the virus is a non-enveloped virus.
8. The composition of claim 1 , wherein the virus is an enveloped virus.
9. The composition of claim 8 , wherein the virus is a Herpes virus or Human respiratory syncytial virus.
10. The composition of claim 1 , wherein the virus is a recombinant virus vector.
11. The composition of claim 10 , wherein the recombinant virus vector encodes a heterologous polypeptide.
12. The composition of claim 11 , wherein the heterologous polypeptide is a viral envelope polypeptide or a viral capsid polypeptide.
13. The composition of claim 1 , wherein the solid amorphous carrier further comprises a pH buffering agent sufficient to provide a final pH of 5.0-8.0.
14. A method for providing an immune response in a mammal comprising:
(a) obtaining a composition in accordance with claim 1 ; and
(b) administering an effective amount of the composition to a mammal.
15. The method of claim 14 , wherein the composition is dissolved in a pharmaceutically compatible liquid before said administering.
16. A method of making a stabilized immunogenic composition comprising:
(a) formulating a solution comprising an antigen in a pharmaceutically acceptable carrier said carrier comprising: (i) PMAL-C16 or (ii) from about 0.1% to 10% of a zwitterionic surfactant; and
(b) drying the solution to provide a stabilized immunogenic composition in a substantially solid amorphous carrier.
17. The method of claim 16 , wherein drying the solution comprises dispersing the solution in a thin film and allowing the liquid to evaporate in the absence of external pressure or heat.
18. The method of claim 16 , wherein prior to drying the solution comprises about 0.1 to 50 mg/ml of PMAL-C16.
19. An immunogenic composition comprising a recombinant virus vector, said recombinant virus vector formulated in a substantially solid amorphous carrier comprising: (i) PMAL-C16; (ii) from about 0.1% to 10% of a zwitterionic surfactant having a lipid group with a chain length of 13-30 carbon atoms; or (iii) from about 0.1 to 50 mg/ml of a zwitterionic surfactant having a lipid group with a chain length of 13-30 carbon atoms.