BACKGROUND Rotavirus vaccines are moderately protective against illness in high mortality settings compared with low mortality settings. Vaccine effectiveness (VE) evaluations may clarify our understanding of these disparities, but estimates among key subpopulations and against rare outcomes are not available in many analyses due to sample size. We combined 25 datasets from test-negative design case-control evaluations in 24 countries that enrolled children with medically-attended diarrhea, laboratory-confirmed rotavirus stool testing, and documented vaccination status. We calculated rotavirus VE stratified by country-level characteristics. METHODS Children 3-59 months old with birthdates and surveillance hospital arrival dates were included; other variables were standardized as available. Children were considered vaccinated if they received ≥1 dose of rotavirus vaccine >14 days before arrival. We summarized child- and country- level characteristics, including national <5-year-old child mortality rate (U5M). Following the manufacturer recommended dose schedule, complete- and partial-series adjusted VE were estimated using logistic regression models. RESULTS We included 6,626 rotavirus positive children (cases) and 19,459 rotavirus negative children (controls). Adjusted complete series VE was significantly higher among children from countries in the low and medium U5M strata (74% (95%CI: 64-81)) compared to all groups within the high U5M strata (range: 52% (95%CI: 42- 60) to 46% (95%CI: 31-57)). Partial series were lower than complete series estimates. CONCLUSIONS These findings are consistent with the published literature, though they suggest heterogeneity in vaccine performance within broad child mortality levels. Our findings also highlight the importance of complete-series vaccination.

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按国家级特征分层的轮状病毒疫苗有效性：2007-2023 年 24 个国家 MNSSTER-V 项目简介。


背景 与低死亡率环境相比，轮状病毒疫苗在高死亡率环境中对疾病具有中度保护作用。疫苗有效性 （VE） 评估可能会阐明我们对这些差异的理解，但由于样本量，许多分析无法获得关键亚群和罕见结果的估计值。我们合并了来自 24 个国家/地区的检测阴性设计病例对照评估的 25 个数据集，这些数据集招募了患有医学就诊的腹泻儿童、实验室确认的轮状病毒粪便检测和记录的疫苗接种状态。我们计算了按国家级特征分层的轮状病毒 VE。方法 纳入 3-59 个月大、出生日期和监测医院到达日期的儿童;其他变量在可用时进行了标准化。如果儿童在抵达前 >14 天接种了 ≥1 剂轮状病毒疫苗，则认为他们已接种疫苗。我们总结了儿童和国家层面的特征，包括全国 <5 岁儿童死亡率 （U5M）。按照制造商推荐的剂量方案，使用 logistic 回归模型估计完整和部分系列调整的 VE。结果 我们纳入了 6,626 名轮状病毒阳性儿童 （病例） 和 19,459 名轮状病毒阴性儿童 （对照）。与高 U5M 层中的所有组 （范围：52% （95%CI： 42-60） 至 46% （95%CI： 31-57）） 相比，来自中低 U5M 层国家的儿童 （74% （95%CI： 64-81）） 的调整后完整系列 VE 显著升高。部分系列低于完整系列估计值。结论 这些发现与已发表的文献一致，尽管它们表明在广泛的儿童死亡率水平内疫苗性能存在异质性。 我们的研究结果还强调了完整系列疫苗接种的重要性。