1. Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults.
- Author
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Noh JY, Jang YS, Lee SN, Choi MJ, Yoon JG, Yu DH, Song JY, Cheong HJ, and Kim WJ
- Subjects
- Adult, Female, Hemagglutination Inhibition Tests, Humans, Influenza A Virus, H1N1 Subtype immunology, Influenza A Virus, H1N1 Subtype pathogenicity, Influenza A Virus, H3N2 Subtype immunology, Influenza A Virus, H3N2 Subtype pathogenicity, Influenza B virus immunology, Influenza B virus pathogenicity, Influenza Vaccines immunology, Influenza, Human immunology, Male, Middle Aged, Single-Blind Method, Vaccines, Inactivated immunology, Influenza Vaccines adverse effects, Influenza Vaccines therapeutic use, Influenza, Human prevention & control, Vaccines, Inactivated adverse effects, Vaccines, Inactivated therapeutic use
- Abstract
Influenza is a major medically attended respiratory illness. The impact of influenza on morbidity and mortality is particularly high in the elderly. Immunosenescence attenuates the immune response of influenza vaccine in the elderly. High-dose influenza vaccine contains 60 μg of hemagglutinin per strain, four times more compared with standard-dose (SD) influenza vaccine. This study is a phase I clinical trial investigating the immunogenicity and safety of the GC3114, high-dose, quadrivalent inactivated influenza vaccine (HD-QIV) in healthy adults aged 19-64 years during the 2017-2018 season. Seroprotection rates of HD-QIV were 100.0% for A/H1N1, 96.67% for A/H3N2, 83.33% for B/Yamagata, and 96.67% for B/Victoria. Seroconversion rate for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 86.67%, 90.0%, 53.33%, and 53.33%, respectively, in the HD-QIV group. The post-/pre-vaccination geometric mean titer ratio (GMTR) was 15.28 for A/H1N1, 8.19 for A/H3N2, 3.56 for B/Yamagata, and 3.03 for B/Victoria in the HD-QIV group. Seroconversion rate and post-/pre-vaccination GMTR for A/H3N2 were significantly higher in the HD-QIV group than in the SD-QIV group (control). No serious adverse events were reported. In conclusion, GC3114 was safe, well-tolerated, and immunogenic in healthy adults. Clinical Trials Identifier: NCT03357263., (Copyright © 2019. Published by Elsevier Ltd.)
- Published
- 2019
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