Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial

ABSTRACT

PURPOSE: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. MATERIALS AND METHODS: The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay. RESULTS: The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI) 61.38–87.46], 72.09% (95% CI 58.69–85.50), and 86.05% (95% CI 75.69–96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI 61.38–87.46), 74.42% (95% CI 61.38–87.46), and 79.07% (95% CI 66.91–91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days. CONCLUSION: The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial.