• Kyuri Kang, Seunghoon Han, Taegon Hong, Sangil Jeon, Jeongki Paek, Jin Han Kang, and Dong Seok Yim.
• The Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Korea.
• Yonsei Med. J. 2016 Nov 1; 57 (6): 135413601354-60.

PurposeA 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 MethodsThe 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.ResultsThe 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.ConclusionThe immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial.

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