New Metabolizable Immunologic Adjuvant for Human Use. 4. Development of Highly Purified Influenza Virus Vaccine in Adjuvant 65

Summary

The development and animal testing of a bivalent influenza virus vaccine in immunologic adjuvant 65 employing a new highly purified viral antigen is described. The enhancement of serologic response to the highly purified viral antigen in adjuvant was as great as achieved heretofore with ordinary Sharpies or protamine-concentrated vaccines used with the adjuvant. Influenza vaccines in adjuvant 65 which were stored at 4°C for periods from 9 to 41 months retained their full antigenic potency and did not acquire toxicity as measured in the guinea pig dermal and mouse peritoneal toxicity assays. The new purified vaccine offers an advantage in reducing the amount of extraneous egg al-lantoic protein in the vaccine thereby affording less chance for allergic sensitization.