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 language | English |
|---|---|
| Pages (from-to) | 5171-5176 |
| Number of pages | 6 |
| Journal | Vaccine |
| Volume | 37 |
| Issue number | 36 |
| DOIs | |
| Publication status | Published - 2019 Aug 23 |
Fingerprint
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 journal › Article
}
TY - JOUR
T1 - 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
AU - Noh, Ji Yun
AU - Jang, Ye Seul
AU - Lee, Saem Na
AU - Choi, Min Joo
AU - Yoon, Jin Gu
AU - Yu, Du Hyeon
AU - Song, Joon-Young
AU - Cheong, Hee-Jin
AU - Kim, Woo Joo
PY - 2019/8/23
Y1 - 2019/8/23
N2 - 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.
AB - 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.
KW - Frail elderly
KW - Influenza vaccines
KW - Influenza, human
UR - http://www.scopus.com/inward/record.url?scp=85069920161&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85069920161&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2019.07.076
DO - 10.1016/j.vaccine.2019.07.076
M3 - Article
C2 - 31377075
AN - SCOPUS:85069920161
VL - 37
SP - 5171
EP - 5176
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 36
ER -