基于检测阴性设计评价兰州羔羊株轮状病毒活疫苗对2~35月龄儿童轮状病毒胃肠炎的保护效果

Effectiveness of the Lanzhou lamp rotavirus vaccine against rovavirus gastroenteritis among children aged 2-35 months:a test-negative design study

目的评价兰州羔羊株轮状病毒(rotavirus,RV)(Lanzhou lamp rotavirus,LLR)疫苗对实验室确诊的儿童轮状病毒胃肠炎(rotacirus gastroenteritis,RVGE)的疫苗保护效果(vaccine effectiveness,VE),为疾病防控政策提供数据支持。方法采用检测阴性设计,通过中国疾病预防控制系统和预防接种信息管理系统收集深圳市龙华区2019―2021年RVGE流行季期间所有实验室确诊腹泻病例和LLR疫苗接种史,使用非条件和条件logistic回归分析模型计算并评价疫苗的校正OR值(adjusted odds ratio,aOR)和VE。结果共1052例实验室确诊腹泻的患儿纳入研究,其中RV阳性组(RVGE+)849例和阴性对照组(RVGE-)203例,共326例匹配成功(RVGE+组163例,RVGE-组163例)。非条件和条件logistic回归分析模型中,≥1剂次LLR疫苗的VE分别为50.7%(95%CI:28.2%~66.2%)和50.4%(95%CI:11.7%~71.8%)。结论LLR疫苗对2~35月龄儿童在RVGE流行季提供中等程度的保护效果,并提示LLR疫苗在2~11月龄儿童的接种率过低和第1剂接种年龄过晚。建议对于错过五价重配轮状病毒减毒活(pentavalent human-reassortant rotavirus,RV5)疫苗接种时间窗的儿童应鼓励尽早接种LLR疫苗。

Objective This study aimed to assess the effectiveness of the Lanzhou lamp rotavirus vaccine(LLR)in mitigating laboratory-confirmed rotavirus gastroenteritis(RVGE)in children,with the objective of informing disease prevention and control policy-making.Methods Data pertaining to confirmed paediatric RVGE and the corresponding LLR vaccination history in Longhua District,Shenzhen City,from 2019-2021 during the RVGE epidemic season,were collected from the China Disease Prevention and Control Information System and the Vaccination Information Management System.A test-negative study design was employed.The adjusted odds ratios(aOR)for LLR vaccination rate and vaccine effectiveness(VE)were calculated using unconditional and conditional logistic regression analysis.Results Of the 1052 children with laboratory-confirmed RVGE included in the study,849 were positive(RVGE+)and 203 were used as a negative control group(RVGE-),with 326 cases successfully matched(163 cases each in the RVGE+and RVGE-groups).In the analysis model,the VE of≥1 dose of LLR vaccine were 45.3(95%CI:17.8-63.6)and 50.4(95%CI:11.7-72.1)in the unconditional and conditional logistic regression models,respectively.Conclusions This suggests that the LLR vaccine offers moderate effectiveness in preventing RVGE in children aged 2-35 months during the epidemic season.However,the study also exposed a low coverage rate of LLR vaccination in children aged 2-11 months,indicating delayed first-dose inoculation.It is recommended that children who have missed the opportunity for pentavalent human-reassortant rotavirus vaccine should receive the LLR vaccine as soon as feasible.