Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial |
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| Authors: | Kyuri Kang Seunghoon Han Taegon Hong Sangil Jeon Jeongki Paek Jin Han Kang Dong-Seok Yim |
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| Affiliation: | 1The Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Korea.;2Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary''s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.;3Department of Pediatrics, Seoul St. Mary''s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. |
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| Abstract: | 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.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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| Keywords: | Trivalent influenza split vaccine safety immunogenicity pre-existing HI titer phase I influenza vaccine study |
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