tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2021 Sep 2;1-9.
doi: 10.1080/21645515.2021.1967041. Online ahead of print.
Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical study
Renfeng Fan[SUP] 1 [/SUP], Xiaoyuan Huang[SUP] 2 3 [/SUP], Xuanxuan Nian[SUP] 2 3 [/SUP], Zhiqiang Ou[SUP] 1 [/SUP], Jian Zhou[SUP] 4 [/SUP], Jiayou Zhang[SUP] 2 3 [/SUP], Peiyu Zeng[SUP] 4 [/SUP], Wei Zhao[SUP] 2 3 [/SUP], Jinglong Deng[SUP] 4 [/SUP], Wei Chen[SUP] 2 3 [/SUP], Shaomin Chen[SUP] 1 [/SUP], Kai Duan[SUP] 2 3 [/SUP], Yingshi Chen[SUP] 1 [/SUP], Xinguo Li[SUP] 2 3 [/SUP], Jikai Zhang[SUP] 1 [/SUP], Xiaoming Yang[SUP] 3 5 [/SUP]
Affiliations
Abstract
To control seasonal influenza epidemics in elders, a quadrivalent, inactivated, split-virion influenza vaccine (IIV4) comprising A and B lineages is produced for young individuals and adults aged ≥60 years. In this phase III, randomized, double-blind, active-controlled trial, we compared safety and immunogenicity of IIV4 with a licensed quadrivalent inactivated vaccine (IIV4-HL) produced by Hualan Biological Engineering during the 2019 influenza season. Participants were randomly assigned to receive IIV4 (n = 959) or IIV4-HL (n = 959). Compared to IIV4-HL, geometric mean titers (GMT) of hemagglutination inhibition (HAI) titers and seroconversion rate (SCR) of IIV4 demonstrated better antibody responses in A lineages (H1N1 and H3N2) (P < .01) and equivalent antibody responses in B lineages (B/Yamagata and B/Victoria) (P > .01) in both age groups. After immunization, IIV4 provided a satisfactory SCR and seroprotection rate (SPR) in elders. No discernible variation in immunogenicity was observed between the two age cohorts. In both age groups, IIV4 and IIV4-HL recipients experienced similar levels of solicited and unsolicited adverse events (AEs), and the incidence of AEs was low in both vaccine groups. Most AEs were of mild-to-moderate severity and no grade 3 AEs in IIV4 group, but AEs in adults aged 60-65 were little higher than in adults over 65 years in IIV4 and IIV4-HL groups (IIV4: 14.66% vs. 10.36%; IIV4-HL:14.67% vs. 11.43%). Totally, IIV4 was generally well tolerated and induced high antibody titers against all four influenza strains in elderly, making it a compelling alternative for the elderly aged ≥60 years.Trial registration: Clinical Trials.gov: 2015L00649-2.
Keywords: Seasonal influenza; immunogenicity; quadrivalent; tolerability; vaccine.
. 2021 Sep 2;1-9.
doi: 10.1080/21645515.2021.1967041. Online ahead of print.
Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical study
Renfeng Fan[SUP] 1 [/SUP], Xiaoyuan Huang[SUP] 2 3 [/SUP], Xuanxuan Nian[SUP] 2 3 [/SUP], Zhiqiang Ou[SUP] 1 [/SUP], Jian Zhou[SUP] 4 [/SUP], Jiayou Zhang[SUP] 2 3 [/SUP], Peiyu Zeng[SUP] 4 [/SUP], Wei Zhao[SUP] 2 3 [/SUP], Jinglong Deng[SUP] 4 [/SUP], Wei Chen[SUP] 2 3 [/SUP], Shaomin Chen[SUP] 1 [/SUP], Kai Duan[SUP] 2 3 [/SUP], Yingshi Chen[SUP] 1 [/SUP], Xinguo Li[SUP] 2 3 [/SUP], Jikai Zhang[SUP] 1 [/SUP], Xiaoming Yang[SUP] 3 5 [/SUP]
Affiliations
- PMID: 34473607
- DOI: 10.1080/21645515.2021.1967041
Abstract
To control seasonal influenza epidemics in elders, a quadrivalent, inactivated, split-virion influenza vaccine (IIV4) comprising A and B lineages is produced for young individuals and adults aged ≥60 years. In this phase III, randomized, double-blind, active-controlled trial, we compared safety and immunogenicity of IIV4 with a licensed quadrivalent inactivated vaccine (IIV4-HL) produced by Hualan Biological Engineering during the 2019 influenza season. Participants were randomly assigned to receive IIV4 (n = 959) or IIV4-HL (n = 959). Compared to IIV4-HL, geometric mean titers (GMT) of hemagglutination inhibition (HAI) titers and seroconversion rate (SCR) of IIV4 demonstrated better antibody responses in A lineages (H1N1 and H3N2) (P < .01) and equivalent antibody responses in B lineages (B/Yamagata and B/Victoria) (P > .01) in both age groups. After immunization, IIV4 provided a satisfactory SCR and seroprotection rate (SPR) in elders. No discernible variation in immunogenicity was observed between the two age cohorts. In both age groups, IIV4 and IIV4-HL recipients experienced similar levels of solicited and unsolicited adverse events (AEs), and the incidence of AEs was low in both vaccine groups. Most AEs were of mild-to-moderate severity and no grade 3 AEs in IIV4 group, but AEs in adults aged 60-65 were little higher than in adults over 65 years in IIV4 and IIV4-HL groups (IIV4: 14.66% vs. 10.36%; IIV4-HL:14.67% vs. 11.43%). Totally, IIV4 was generally well tolerated and induced high antibody titers against all four influenza strains in elderly, making it a compelling alternative for the elderly aged ≥60 years.Trial registration: Clinical Trials.gov: 2015L00649-2.
Keywords: Seasonal influenza; immunogenicity; quadrivalent; tolerability; vaccine.