Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial.
10.3349/ymj.2016.57.6.1354
- Author:
Kyuri KANG
1
;
Seunghoon HAN
;
Taegon HONG
;
Sangil JEON
;
Jeongki PAEK
;
Jin Han KANG
;
Dong Seok YIM
Author Information
1. The Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- Publication Type:Clinical Trial ; Original Article
- Keywords:
Trivalent influenza split vaccine;
safety;
immunogenicity;
pre-existing HI titer;
phase I influenza vaccine study
- MeSH:
Adult*;
Hemagglutination;
Humans;
Influenza Vaccines*;
Influenza, Human*;
Korea;
Male;
Mass Screening;
Seroconversion
- From:Yonsei Medical Journal
2016;57(6):1354-1360
- CountryRepublic of Korea
- Language:English
-
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.
