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KMID : 0311120160570061354
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Yonsei Medical Journal
2016 Volume.57 No. 6 p.1354 ~ p.1360
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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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Kang Kyu-Ri
Han Seung-Hoon
Hong Tae-Gon
Jeon Sang-Il
Paek Jeong-ki
Kang Jin-Han
Yim Dong-Seok
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Abstract
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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.
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KEYWORD
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Trivalent influenza split vaccine, safety, immunogenicity, pre-existing HI titer, phase I influenza vaccine study
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