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

Ji Yun Noh, Ye Seul Jang, Saem Na Lee, Min Joo Choi, Jin Gu Yoon, Du Hyeon Yu, Joon-Young Song, Hee-Jin Cheong, Woo Joo Kim

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)5171-5176
Number of pages6
JournalVaccine
Volume37
Issue number36
DOIs
Publication statusPublished - 2019 Aug 23

Fingerprint

Clinical Trials, Phase I
Influenza Vaccines
Controlled Clinical Trials
influenza
clinical trials
Inactivated Vaccines
immune response
vaccines
Safety
dosage
Victoria
Human Influenza
seroconversion
Vaccination
vaccination
Hemagglutinins
hemagglutinins
Clinical Trials
morbidity
Morbidity

Keywords

  • Frail elderly
  • Influenza vaccines
  • Influenza, human

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

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. / Noh, Ji Yun; Jang, Ye Seul; Lee, Saem Na; Choi, Min Joo; Yoon, Jin Gu; Yu, Du Hyeon; Song, Joon-Young; Cheong, Hee-Jin; Kim, Woo Joo.

In: Vaccine, Vol. 37, No. 36, 23.08.2019, p. 5171-5176.

Research output: Contribution to journalArticle

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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.",
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AU - Yoon, Jin Gu

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