Effectiveness of the live attenuated rotavirus vaccine produced by a domestic manufacturer in China studied using a population-based case-control design
Effectiveness of the live attenuated rotavirus vaccine produced by a domestic manufacturer in China studied using a population-based case-control design
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DOI：
10.1038/emi.2015.64
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发表时间：
2015-10-28
影响因子：
13.2
通讯作者：
Wang, Xuan-Yi
中科院分区：
文献类型：
--
作者：
Zhen, Shan-Shan;Li, Yue;Wang, Xuan-Yi
轮状病毒(RV)免疫接种是中国预防轮状病毒感染的一种潜在的经济有效的措施。然而，国内制造商生产的唯一获得许可的轮状病毒疫苗(兰州羔羊轮状病毒疫苗，LLR)的有效性尚未通过适当设计的临床试验来证明。2011年10月至2012年3月，在正定县农村开展了一项以人群为基础的5岁儿童活动性腹泻监测的病例对照研究，以评估LLR的潜在保护作用。在研究期间，308例腹泻被确认为由轮状病毒感染引起，发病率为48.0/1000人/年。RV血清型以G3为主(61.5%)，其次为G1(15.2%)和G9(6.5%)。总体而言，确定的保护率为35.0%(95%可信区间，13.0%-52.0%)，在由G3型血清引起的中度轮状病毒胃肠炎病例中发现更高的保护率(52.0%；95%可信区间：2.0%-76.1%)。同时进行的一项病例对照研究在同一人群中比较了非轮状病毒病毒性腹泻病例和非腹泻对照病例，发现轮状病毒疫苗对非轮状病毒腹泻没有保护作用。即使在不太理想的免疫方案下，口服LLR对轮状病毒胃肠炎也有一定程度的保护作用。然而，还需要进一步的研究来了解LLR的全部特征，包括按照最佳方案给药的有效性，诱发肠套叠的潜在风险，以及LLR的直接和间接保护作用。
A universal rotavirus (RV) immunization program is a potentially cost-effective measure for preventing RV infection in China. However, the efficacy of the only licensed RV vaccine (Lanzhou lamb rotavirus vaccine, LLR), which is made by a domestic manufacturer, has not been proven by a properly designed clinical trial. In October 2011 to March 2012, to measure the potential protection provided by LLR, a case-control study nested in a population-based active diarrhea surveillance study of children < 5 years of age was conducted in rural Zhengding county. During the study period, 308 episodes of diarrhea were identified as being caused by RV infection, resulting in an incidence rate of 48.0/1000 people/year. The predominant RV serotype was G3 (61.5%), followed by G1 (15.2%), and G9 (6.5%). Overall, a protection of 35.0% (95% confidence interval (CI), 13.0%-52.0%) was identified, and higher protection was found among moderate RV gastroenteritis cases caused by the serotype G3 (52.0%; 95% CI: 2.0%-76.1%). A concurrently conducted case-control study comparing non-RV viral diarrheal cases with non-diarrheal controls in the same population found that the RV vaccine offered no protection against non-RV diarrhea. Even under a less ideal immunization schedule, the oral LLR conferred a certain level of protection against RV gastroenteritis. However, further studies are needed to understand the full characteristics of the LLR, including its efficacy when administered following the optimal regimen, the potential risk of inducing intussusception, and the direct and indirect protective effects of LLR.