tetano
Editor, Senior Moderator
Vaccine
. 2022 Jul 7;S0264-410X(22)00846-5.
doi: 10.1016/j.vaccine.2022.06.078. Online ahead of print.
Immunogenicity and safety of an egg culture-based quadrivalent inactivated non-adjuvanted subunit influenza vaccine in subjects ≥3 years: A randomized, multicenter, double-blind, active-controlled phase III, non-inferiority trial
Yuhui Zhang[SUP] 1 [/SUP], Yanxia Wang[SUP] 2 [/SUP], Chunyu Jia[SUP] 3 [/SUP], Guangfu Li[SUP] 4 [/SUP], Wei Zhang[SUP] 5 [/SUP], Qin Li[SUP] 6 [/SUP], Xiaofen Chen[SUP] 7 [/SUP], Wenna Leng[SUP] 8 [/SUP], Lili Huang[SUP] 9 [/SUP], Zhiqiang Xie[SUP] 10 [/SUP], Huiping Zhang[SUP] 11 [/SUP], Wangyang You[SUP] 12 [/SUP], Rui An[SUP] 13 [/SUP], Hongyan Jiang[SUP] 14 [/SUP], Xue Zhao[SUP] 15 [/SUP], Siyan Cheng[SUP] 16 [/SUP], Jiebing Tan[SUP] 17 [/SUP], Weiyang Cui[SUP] 18 [/SUP], Feilong Gao[SUP] 19 [/SUP], Weifeng Lu[SUP] 20 [/SUP], Yuping Wang[SUP] 21 [/SUP], Yongli Yang[SUP] 22 [/SUP], Shengli Xia[SUP] 23 [/SUP], Shuai Wang[SUP] 24 [/SUP]
Affiliations
Abstract
Subunit influenza vaccine only formulated with surface antigen proteins has better safety profiles relative to split-virion influenza vaccine. Compared to the traditional quadrivalent split-virion influenza vaccine, a novel quadrivalent subunit influenza vaccine is urgently needed in China. We completed a phase 3, randomized, double-blind, active-controlled, non-inferiority clinical study at two sites in Henan Province, China. Eligible volunteers were split into four age cohorts (3-8 years, 9-17 years, 18-64 years, and ≥ 65 years, based on their dates of birth) and randomly assigned (1:1) to the subunit and the split-virion ecNAIIV4 groups. All volunteers were intramuscularly administered a single vaccine dose at baseline, and children aged 3-8 years received a boosting dose at day 28. And the immune response was evaluated by measuring hemagglutinin-inhibition antibody titers against the four vaccine strains in blood samples. Safety profiles had nonsignificant differences between the study groups in ≥ 3 years cohort. Most adverse reactions post-vaccination, both local and systemic, were mild to moderate and resolved within 3 days. And no serious adverse events occurred. The immunogenicity of the trial vaccine was non-inferior to the comparator. Further, a two-dose vaccine series can provide better seroprotection than that of a one-dose series in children aged 3-8 years, with clinically acceptable safety profiles. Clinical Trials Registration. ChiCTR2100049934.
Keywords: Influenza vaccine; Non-adjuvanted; Non-inferiority; Quadrivalent; Subunit.
. 2022 Jul 7;S0264-410X(22)00846-5.
doi: 10.1016/j.vaccine.2022.06.078. Online ahead of print.
Immunogenicity and safety of an egg culture-based quadrivalent inactivated non-adjuvanted subunit influenza vaccine in subjects ≥3 years: A randomized, multicenter, double-blind, active-controlled phase III, non-inferiority trial
Yuhui Zhang[SUP] 1 [/SUP], Yanxia Wang[SUP] 2 [/SUP], Chunyu Jia[SUP] 3 [/SUP], Guangfu Li[SUP] 4 [/SUP], Wei Zhang[SUP] 5 [/SUP], Qin Li[SUP] 6 [/SUP], Xiaofen Chen[SUP] 7 [/SUP], Wenna Leng[SUP] 8 [/SUP], Lili Huang[SUP] 9 [/SUP], Zhiqiang Xie[SUP] 10 [/SUP], Huiping Zhang[SUP] 11 [/SUP], Wangyang You[SUP] 12 [/SUP], Rui An[SUP] 13 [/SUP], Hongyan Jiang[SUP] 14 [/SUP], Xue Zhao[SUP] 15 [/SUP], Siyan Cheng[SUP] 16 [/SUP], Jiebing Tan[SUP] 17 [/SUP], Weiyang Cui[SUP] 18 [/SUP], Feilong Gao[SUP] 19 [/SUP], Weifeng Lu[SUP] 20 [/SUP], Yuping Wang[SUP] 21 [/SUP], Yongli Yang[SUP] 22 [/SUP], Shengli Xia[SUP] 23 [/SUP], Shuai Wang[SUP] 24 [/SUP]
Affiliations
- PMID: 35810063
- DOI: 10.1016/j.vaccine.2022.06.078
Abstract
Subunit influenza vaccine only formulated with surface antigen proteins has better safety profiles relative to split-virion influenza vaccine. Compared to the traditional quadrivalent split-virion influenza vaccine, a novel quadrivalent subunit influenza vaccine is urgently needed in China. We completed a phase 3, randomized, double-blind, active-controlled, non-inferiority clinical study at two sites in Henan Province, China. Eligible volunteers were split into four age cohorts (3-8 years, 9-17 years, 18-64 years, and ≥ 65 years, based on their dates of birth) and randomly assigned (1:1) to the subunit and the split-virion ecNAIIV4 groups. All volunteers were intramuscularly administered a single vaccine dose at baseline, and children aged 3-8 years received a boosting dose at day 28. And the immune response was evaluated by measuring hemagglutinin-inhibition antibody titers against the four vaccine strains in blood samples. Safety profiles had nonsignificant differences between the study groups in ≥ 3 years cohort. Most adverse reactions post-vaccination, both local and systemic, were mild to moderate and resolved within 3 days. And no serious adverse events occurred. The immunogenicity of the trial vaccine was non-inferior to the comparator. Further, a two-dose vaccine series can provide better seroprotection than that of a one-dose series in children aged 3-8 years, with clinically acceptable safety profiles. Clinical Trials Registration. ChiCTR2100049934.
Keywords: Influenza vaccine; Non-adjuvanted; Non-inferiority; Quadrivalent; Subunit.