A Phase I, Randomized, Controlled Trial to Study the Reactogenicity and Immunogenicity of a Nasal, Inactivated Trivalent Influenza Virus Vaccine in Healthy Adults

Abstract

We performed a randomized, placebo-controlled, dose-escalating clinical trial to evaluate thesafety and immunogenicity of an inactivated, split virion, trivalent, nasal influenza vaccine usinglipid/polysaccharide molecules as carriers. A total of 64 adults (mean age 29; range 19-69 years)were randomly allocated to receive a mixture of lipid/polysaccharide carrier molecules and 7.5,15, or 30 µg hemagglutinin antigen of each of the three influenza strains (A/Johannesburg/82/96[H1N1], A/Nanchang/933/95 [H3N2], B/Harbin/07/94) or placebo via nasal spray on twooccasions separated by 28 days. Adverse events were assessed immediately after immunizationand for 14 days after each dose. Nasal and serum antibodies were measured before and twoweeks after each dose. All but three participants completed the study; no withdrawals werebecause of adverse events. Adverse events were similar immediately after immunization exceptfor anterior nasal dripping after the first dose which was more common in the combined vaccinegroups (64.4%) than in the placebo group (31.3%; p