Center for Disease Control and Prevention of Dongguan City, Dongguan.
National Institutes for Food and Drug Control.
J Infect Dis. 2019 Jul 2;220(3):392-399. doi: 10.1093/infdis/jiz129.
This study tested the hypothesis that the immunogenicity and safety of the simultaneous administration of enterovirus 71 (EV71) vaccine (dose 1) with recombinant hepatitis B vaccine (HepB) on day 1 and EV71 vaccine (dose 2) with group A meningococcal polysaccharide vaccine (MenA) on day 30 is not inferior to separate administration of each vaccine.
The study was designed as a randomized, open-label, noninferiority trial. A total of 775 healthy infants aged 6 months were randomly assigned in a ratio of 1:1:1 to receive simultaneous administration of EV71 vaccine (dose 1) and HepB on day 1 and EV71 vaccine (dose 2) and MenA on day 30 (the SI group); administration of doses 1 and 2 of EV71 vaccine on days 1 and 30, respectively (the SE1 group); or administration of HepB and MenA on days 1 and 30, respectively (the SE2 group).
According to the per protocol set, antibody responses against EV71, hepatitis B virus (HBV), and group A meningococcal polysaccharide were similar regardless of administration schedule. With the non-inferiority margin setting at 10%, the seroconversion rates of the three pathogens in the SI group (100% [98.25, 100], 44.84% [38.20, 51.63] and 27.83% [21.91, 34.38]) were not inferior to those in SE1 or SE2 group (100% [98.31, 100], 44.35% [37.82, 51.02] and 29.17% [23.20, 35.72], respectively). Frequencies of adverse reactions to each vaccination regimen were comparable (60.62% in the SI group vs 52.33% in the SE1 group and 56.98% in the SE2 group; P = .16).
Simultaneous administration of combined EV71 vaccine with HepB and MenA has noninferior immunogenicity and safety, compared with separate administration of these vaccines.
NCT03274102.
本研究旨在检验同时接种肠道病毒 71 型（EV71）疫苗（第 1 剂）和重组乙型肝炎疫苗（HepB）于第 1 天以及 EV71 疫苗（第 2 剂）和 A 群脑膜炎球菌多糖疫苗（MenA）于第 30 天（SI 组），与分别接种各疫苗的免疫原性和安全性非劣效性假设。
本研究设计为随机、开放标签、非劣效性试验。775 名 6 月龄健康婴儿以 1:1:1 的比例随机分为三组，分别接受同时接种 EV71 疫苗（第 1 剂）和 HepB 于第 1 天以及 EV71 疫苗（第 2 剂）和 MenA 于第 30 天（SI 组）；分别于第 1 天和第 30 天接种 EV71 疫苗（第 1 剂和第 2 剂）（SE1 组）；或分别于第 1 天和第 30 天接种 HepB 和 MenA（SE2 组）。
根据方案设定，无论接种方案如何，针对 EV71、乙型肝炎病毒（HBV）和 A 群脑膜炎球菌多糖的抗体应答相似。在非劣效性边界设定为 10%的情况下，SI 组三种病原体的血清转化率（100%[98.25，100]、44.84%[38.20，51.63]和 27.83%[21.91，34.38]）不劣于 SE1 或 SE2 组（100%[98.31，100]、44.35%[37.82，51.02]和 29.17%[23.20，35.72]）。三种接种方案的不良反应发生率相当（SI 组 60.62%，SE1 组 52.33%，SE2 组 56.98%；P=0.16）。
与分别接种这些疫苗相比，同时接种联合 EV71 疫苗与 HepB 和 MenA 具有非劣效的免疫原性和安全性。
NCT03274102。
