一种五价人-牛重配轮状病毒疫苗（RV5）在中国健康婴儿中的有效性和安全性：一项随机、双盲、安慰剂对照试验。
Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial.
作者信息
Mo Zhaojun, Mo Yi, Li Mingqiang, Tao Junhui, Yang Xu, Kong Jilian, Wei Dingkai, Fu Botao, Liao Xueyan, Chu Jianli, Qiu Yuanzheng, Hille Darcy A, Nelson Micki, Kaplan Susan S
机构信息
Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
Liuzhou City Center for Disease Control and Prevention, Liuzhou, Guangxi, China.
出版信息
Vaccine. 2017 Oct 13;35(43):5897-5904. doi: 10.1016/j.vaccine.2017.08.081. Epub 2017 Sep 19.
BACKGROUND
A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RotaTeq™, RV5) against rotavirus gastroenteritis (RVGE).
METHODS
4040 participants aged 6-12weeks were enrolled and randomly assigned to either 3 oral doses of RV5 (n=2020) or placebo (n=2020), administered ∼4weeks apart. The participants also received OPV and DTaP in a concomitant or staggered fashion. The primary objective was to evaluate vaccine efficacy (VE) against naturally-occurring RVGE at least 14days following the third dose. Key secondary objectives included: VE against naturally-occurring severe RVGE and VE against severe and any-severity RVGE caused by rotavirus serotypes contained in the vaccine, occurring at least 14days after the third dose. All adverse events (AEs) were collected for 30days following each dose. Serious AEs (SAEs) and intussusception cases were collected during the entire study. (ClinicalTrials.gov registry: NCT02062385).
RESULTS
VE against RVGE of any-severity caused by any serotype was 69.3% (95% CI: 54.5, 79.7). The secondary efficacy analysis showed an efficacy of: 78.9% (95% CI: 59.1, 90.1) against severe RVGE caused by any serotype; 69.9% (95% CI: 55.2, 80.3) and 78.9% (95% CI: 59.1, 90.1) against any-severity and severe RVGE caused by serotypes contained in the vaccine, respectively. Within 30days following any vaccination, 53.5% (1079/2015) and 53.3% (1077/2019) of participants reported at least one AE, and 5.8% (116/2015) and 5.7% (116/2019) reported SAEs in the vaccine and placebo groups, respectively. No SAEs were considered vaccine-related in recipients of RV5. Two intussusception cases were reported in recipients of RV5 who recovered after receiving treatment. Neither was considered vaccine-related.
CONCLUSIONS
In Chinese infants, RV5 was efficacious against any-severity and severe RVGE caused by any serotype and generally well-tolerated with respect to AEs.
背景
在中国健康婴儿中进行了一项随机、双盲、安慰剂对照的多中心试验，以评估五价人-牛重配轮状病毒疫苗（Rotateq™，RV5）预防轮状病毒胃肠炎（RVGE）的有效性和安全性。
方法
招募了4040名6至12周龄的参与者，随机分为两组，分别接受3剂口服RV5（n = 2020）或安慰剂（n = 2020），给药间隔约4周。参与者还以同时或错开的方式接受口服脊髓灰质炎疫苗（OPV）和白百破疫苗（DTaP）。主要目标是评估第三剂后至少14天针对自然发生的RVGE的疫苗效力（VE）。关键次要目标包括：第三剂后至少14天针对自然发生的严重RVGE的VE，以及针对疫苗中包含的轮状病毒血清型引起的严重和任何严重程度RVGE的VE。每次给药后收集30天内的所有不良事件（AE）。在整个研究期间收集严重不良事件（SAE）和肠套叠病例。（ClinicalTrials.gov注册号：NCT02062385）。
结果
针对任何血清型引起的任何严重程度的RVGE的VE为69.3%（95%CI：54.5，79.7）。次要疗效分析显示，针对任何血清型引起的严重RVGE的效力为：78.9%（95%CI：59.1，90.1）；针对疫苗中包含的血清型引起的任何严重程度和严重RVGE的效力分别为69.9%（95%CI：55.2，80.3）和78.9%（95%CI：59.1，90.1）。在任何一次疫苗接种后的30天内，疫苗组和安慰剂组分别有53.5%（1079/2015）和53.3%（1077/2019）的参与者报告了至少一次AE，分别有5.8%（116/2015）和5.7%（116/2019）的参与者报告了SAE。在接受RV5的受试者中，没有SAE被认为与疫苗相关。接受RV5的受试者报告了2例肠套叠病例，接受治疗后康复。两者均不被认为与疫苗相关。
结论
在中国婴儿中，RV5对任何血清型引起的任何严重程度和严重RVGE均有效，且在AE方面总体耐受性良好。
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