Li Rong-cheng, Huang Teng, Li Yanping, Luo Dong, Tao Junhui, Fu Botao, Si Guoai, Nong Yi, Mo Zhaojun, Liao XueYan, Luan Ivy, Tang Haiwen, Rathi Niraj, Karkada Naveen, Han Htay Htay
GuangXi Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
Liucheng County Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
Hum Vaccin Immunother. 2014;10(1):11-8. doi: 10.4161/hv.26319. Epub 2013 Sep 6.
Rotaviruses (RV) are a major cause of severe gastroenteritis (GE) in children aged<5 y. For the first time in China, we assessed the efficacy of two oral doses of the human rotavirus vaccine (RIX4414) in infants during the first two years of life (113808/NCT01171963). Healthy infants aged 6-16 weeks were randomized (1:1) to receive two oral doses of either the RIX4414 vaccine/placebo according to a 0, 1 month schedule. Vaccine efficacy (VE) against severe RVGE was assessed from two weeks post-Dose 2 up until the end of the second RV season and calculated with its 95% confidence intervals (CI). The primary efficacy objective was met if the lower limit of the 95% CI on VE was ≥10%. Unsolicited symptoms reported during the 31-d post-vaccination follow-up period and serious adverse events (SAEs) reported throughout the study were assessed. Of 3333 enrolled infants, 3148 were included in the according-to-protocol efficacy cohort. Over two consecutive RV seasons, fewer severe RVGE episodes were reported in the RIX4414 group (n=21) vs. the placebo group (n=75). VE against severe RVGE was 72% (95% CI: 54.1-83.6); the lower limit of the 95% CI on VE was >10%. The number of unsolicited symptoms and SAEs reported was similar between both groups. Thirteen deaths (RIX4414=6; placebo=7) occurred during the study. All SAEs and deaths in the RIX4414 group were considered unrelated to vaccination. Two oral doses of RIX4414 vaccine provided a substantial level of protection against severe RVGE in Chinese children during the first two years of life.
轮状病毒（RV）是5岁以下儿童严重胃肠炎（GE）的主要病因。在中国，我们首次评估了两剂口服人轮状病毒疫苗（RIX4414）在婴儿出生后两年内的有效性（113808/NCT01171963）。6至16周龄的健康婴儿按1:1随机分组，根据0、1月龄的时间表接受两剂口服RIX4414疫苗/安慰剂。从第2剂接种后两周直至第二个RV季节结束，评估针对严重RVGE的疫苗效力（VE），并计算其95%置信区间（CI）。如果VE的95%CI下限≥10%，则达到主要效力目标。评估接种疫苗后31天随访期内报告的非预期症状以及整个研究期间报告的严重不良事件（SAE）。在3333名入组婴儿中，3148名被纳入符合方案效力队列。在连续两个RV季节中，RIX4414组（n = 21）报告的严重RVGE发作次数少于安慰剂组（n = 75）。针对严重RVGE的VE为72%（95%CI：54.1 - 83.6）；VE的95%CI下限>10%。两组报告的非预期症状和SAE数量相似。研究期间发生了13例死亡（RIX4414组 = 6例；安慰剂组 = 7例）。RIX4414组的所有SAE和死亡均被认为与疫苗接种无关。两剂口服RIX4414疫苗为中国儿童出生后两年内的严重RVGE提供了高水平的保护。
