Comparison of immunogenicity between candidate influenza A(H3N2) virus vaccine strains in Japan: A randomized controlled trial using a monovalent vaccine of A/Saitama/103/2014 (CEXP-002) and A/Hong Kong/4801/2014 (X-263).

Autor: Kase T; Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan., Inoue M; SOUSEIKAI PS Clinic, Fukuoka, Japan., Morikawa S; Department of Virology, Osaka Institute of Public Health, Osaka, Japan., Kumashiro H; SOUSEIKAI PS Clinic, Fukuoka, Japan., Hiroi S; Department of Virology, Osaka Institute of Public Health, Osaka, Japan., Nakata K; Department of Virology, Osaka Institute of Public Health, Osaka, Japan., Ito K; Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan; Healthcare Management, College of Healthcare Management, Miyama, Japan; Clinical Epidemiology Research Center, SOUSEIKAI, Fukuoka, Japan., Ishibashi M; SOUSEIKAI PS Clinic, Fukuoka, Japan., Tsuru T; SOUSEIKAI PS Clinic, Fukuoka, Japan., Irie S; SOUSEIKAI, Fukuoka, Japan., Maeda A; Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan., Ohfuji S; Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan., Fukushima W; Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan. Electronic address: wakaba@med.osaka-cu.ac.jp., Hirota Y; Clinical Epidemiology Research Center, SOUSEIKAI, Fukuoka, Japan; College of Healthcare Management, Miyama, Japan.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2020 Sep 29; Vol. 38 (42), pp. 6524-6532. Date of Electronic Publication: 2020 Aug 29.
DOI: 10.1016/j.vaccine.2020.08.025
Abstrakt: Background: For the 2017-18 influenza season, A/Saitama/103/2014 (CEXP-002) (Saitama strain) was antigenically more similar to prior circulating strains than A/Hong Kong/4801/2014 (X-263) (Hong Kong strain) in a ferret model and was selected as the A(H3N2) vaccine virus strain in Japan. However, the Saitama strain grew poorly, and the Japanese government switched to the Hong Kong strain, raising public concerns of poor effectiveness. To enhance understanding of the correlation between antigenicity in experimental models and immunogenicity, as a surrogate measure of vaccine effectiveness, in the human population, we compared the immunogenicity of specially-prepared single dose monovalent influenza A(H3N2) vaccines containing the Saitama or the Hong Kong strain.
Methods: A randomized controlled trial of 100 healthy adults aged 20-64 years (n = 50/group) was conducted. Virus neutralization assay was performed on sera from days 0 (pre-vaccination) and 21 (post-vaccination). Geometric mean titer (GMT), mean fold rise (MFR), seroconversion proportion (SCP), and seroprotection proportion (SPP) were calculated for vaccine strains and a representative circulating A(H3N2) virus strain (A/Osaka/188/2017).
Results: For the Hong Kong strain, post-vaccination GMT was significantly higher in the Hong Kong vaccine recipients (1:546 vs 1:260, p < 0.01), but MFR, SCP, and SPP were similar for both vaccine groups. For the Saitama strain, post-vaccination GMT (1:116 vs 1:61, p = 0.01) and SPP (86% vs 68%, p = 0.03) were significantly higher in the Hong Kong vaccine recipients, but MFR and SCP were similar for both vaccine groups. Against A/Osaka/188/2017, post-vaccination GMT and MFR were similar in both vaccine groups, but SCP (32% vs 4%, p < 0.01) and SPP (28% vs. 6%, p < 0.01) were significantly higher in the Hong Kong vaccine recipients.
Conclusion: The Hong Kong vaccine induced better or equivalent immunogenicity in comparison to the Saitama vaccine. Our trial showed that antigenic similarity in experimental models does not necessarily correlate with immunogenicity in the human population.
Clinical Trial Registration: UMIN000029293.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ‘TK has received a reward for advisor tasks from The Biken Foundation from April 2016 to March 2018. The other authors have nothing to declare’.
(Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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