Abstract
revised) Background: Significant influenza morbidity and mortality persists despite use of current vaccines. The most effective existing vaccine for healthy adults is standard dose split virus vaccine (SDTIV), which prevents only 60% of influenza infection. A high dose trivalent inactivated influenza vaccine (HDTIV) has shown greater immunogenicity and efficacy in older subjects. This trial was designed to assess immunogenicity and reactogenicity of HDTIV versus SDTIV in HCWs. Methods: We conducted a prospective, randomized controlled, observer blind trial of HDTIV (60μg antigen/strain) versus SDTIV (15μg antigen/strain) in healthy HCWs 18-64yrs of age in November, 2014. The primary outcome was seroconversion to vaccine strains measured by change in HAI GMT from day 0 (pre-vaccine) to day 21 post-vaccination. Results: 47 HCWs were enrolled; 37 were female; the median age was 40yrs (range 22-64yrs). 25 received HDTIV (24 with HAI results) and 22 SDTIV. There was no significant difference in pre-vaccination HAI GMTs. Post-vaccination HAI GMTs for vaccine strains were: for A(H3N2) 1092 HD v 405 SD, A(H1N1) 1337 HD V 601 SD, and B 2061 HD v 1165 SD (all p /=65 years of age: a randomized, controlled, phase II trial. Vaccine, 32(21), 2507-2517.
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