Clinical Trials with Alice Strain, Live, Attenuated, Serum Inhibitor-Resistant Intranasal Influenza A Vaccine

Abstract

Two clinical trials with Alice strain intranasal influenza vaccine were performed. In study no. I (utilizing random selection and double-blind control), 50 subjects received a bivalent inactivated influenza vaccine intramuscularly, 99 subjects received Alice strain vaccine intranasally, and 50 subjects received a placebo intranasally. No symptomatology could be attributed to the intranasal route of immunization. Convalescent-phase geometric mean titers of hemagglutination inhibition antibody were higher after intramuscular vaccination; seroconversion occurred in 16 of 17 recipients of the Alice strain, with initial titers of < I:8. Clinical and virologic surveillance for 20 weeks after vaccination revealed no influenza A illnesses in participants of the study. In study no. 2,75% of the subjects with initial nasal antibody titers of < 1:3 developed measurable nasal antibody after receiving Alice strain vaccine.