Polychlorinated biphenyls and squalene-containing adjuvants
When using squalene in a vaccine adjuvant, there is a possibility of contamination with polychlorinated biphenyls (PCBs). Environmental exposure to PCBs may adversely affect children's immune responses to routine vaccinations. Thus the invention uses squalene with low or no PCB contamination, particularly when derived from shark liver.
1. A pharmaceutical composition comprising an oil-in-water emulsion comprising squalene, wherein the emulsion comprises less than 661 picograms of polychlorinated biphenyls (PCBs) per gram of squalene (toxic equivalent; TEQ).
2. The pharmaceutical composition of claim 1 , further comprising an antigen.
3. The composition of claim 1 , wherein the emulsion comprises less than 10 picograms of PCBs per gram of squalene (TEQ).
4. The composition of claim 2 , wherein the emulsion comprises less than 10 picograms of PCBs per gram of squalene (TEQ).
5. A pharmaceutical composition comprising an oil-in-water emulsion comprising squalene, wherein the emulsion contains no hexachlorobiphenyl.
6. The composition of claim 5 , wherein the emulsion contains no 3′,4,4′,5,5′-hexachlorobiphenyl.
7. A pharmaceutical composition comprising an oil-in-water emulsion comprising squalene, wherein the emulsion contains no 3,3′,4,4′,5-pentachlorobiphenyl.
8. A pharmaceutical composition comprising an oil-in-water emulsion comprising squalene, wherein the emulsion contains no 3,3′,4,4′-tetrachlorobiphenyl.
9. A pharmaceutical composition comprising an oil-in-water emulsion comprising squalene, wherein the emulsion contains no 3,4,4′,5-tetrachlorobiphenyl.
10. The composition of claim 1 , wherein the TEQ is calculated based on the twelve non-ortho and mono-ortho substituted PCBs.
11. The composition of claim 2 , wherein the TEQ is calculated based on the twelve non-ortho and mono-ortho substituted PCBs.
12. The composition of claim 1 , wherein the emulsion comprises squalene and a polyoxyethylene sorbitan ester surfactant.
13. The composition of claim 2 , wherein the emulsion comprises squalene and a polyoxyethylene sorbitan ester surfactant.
14. The composition of claim 12 , wherein the polyoxyethylene sorbitan ester surfactant is polysorbate 80.
15. The composition of claim 13 , wherein the polyoxyethylene sorbitan ester surfactant is polysorbate 80.
16. The composition of claim 1 , wherein the emulsion comprises squalene and a sorbitan ester.
17. The composition of claim 2 , wherein the emulsion comprises squalene and a sorbitan ester.
18. The emulsion composition of claim 16 , wherein the sorbitan ester is sorbitan trioleate.
19. The composition of claim 17 , wherein the sorbitan ester is sorbitan trioleate.
20. The composition of claim 1 , wherein the emulsion comprises between 5-20% by volume of oil.
21. The composition of claim 2 , wherein the emulsion comprises between 5-20% by volume of oil.
22. The composition of claim 1 , wherein the emulsion comprises from 0.5-5% by volume of surfactant.
23. The composition of claim 2 , wherein the emulsion comprises from 0.5-5% by volume of surfactant.
24. The composition of claim 1 , wherein the emulsion comprises squalene, polysorbate 80, and sorbitan trioleate.
25. The composition of claim 2 , wherein the emulsion comprises squalene, polysorbate 80, and sorbitan trioleate.
26. The composition of claim 1 , wherein the emulsion comprises squalene, an α-tocopherol, and polysorbate 80.
27. The composition of claim 2 , wherein the emulsion comprises squalene, an α-tocopherol, and polysorbate 80.