Nanque Line M, Varma Anshu, Thysen Sanne M, Benn Christine S, Martins Justiniano Sd, Jensen Aksel Kg, Correia Claudino, Möller Sören, Van den Biggelaar Anita, Aaby Peter, Fisker Ane B
Bandim Health Project, Bissau, Guinea-Bissau; Bandim Health Project, Research Unit OPEN, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Bandim Health Project, Bissau, Guinea-Bissau.
J Infect. 2024 Dec;89(6):106302. doi: 10.1016/j.jinf.2024.106302. Epub 2024 Sep 30.
To investigate in a cluster-randomised trial whether a campaign with oral polio vaccine (C-OPV) reduced mortality and morbidity.
We randomised 222 village clusters under demographic surveillance to an intervention (health check and C-OPV) or control group (health check only). Children aged 0-8 months were eligible. In Cox proportional hazards models with age as the underlying timescale, we compared rates of non-accidental mortality/hospital admission (composite primary outcome) during 12 months of follow-up. Secondary analyses considered non-accidental admission and mortality as separate outcomes. Potential effect modifiers identified in prior studies including sex, season, and timing of the first routine OPV dose (OPV0, scheduled at birth) were assessed.
Among 10,175 children (5288 in 111 intervention clusters/4887 in 111 control clusters), we observed 265 deaths/admissions during 7616 person-years at risk (intervention: 129; control: 136). C-OPV did not reduce the composite endpoint, hazard ratio (HR): 0.87, 95%CI: 0.68-1.12 or its separate components. C-OPV reduced the risk in children receiving OPV0<15 days of birth (HR=0.66, 95%CI: 0.46-0.95), but not in other children (p for interaction: 0.03). Interactions for other potential effect modifiers were not statistically significant.
C-OPV had no overall effect on mortality/admissions, but the effect differed by early priming with OPV0.
在一项整群随机试验中研究口服脊髓灰质炎疫苗强化免疫活动（C-OPV）是否能降低死亡率和发病率。
我们将222个处于人口监测下的村庄整群随机分为干预组（健康检查和C-OPV）或对照组（仅健康检查）。0至8个月大的儿童符合条件。在以年龄为基本时间尺度的Cox比例风险模型中，我们比较了随访12个月期间非意外死亡率/住院率（复合主要结局）。次要分析将非意外住院和死亡视为单独结局。评估了先前研究中确定的潜在效应修饰因素，包括性别、季节和首剂常规口服脊髓灰质炎疫苗（OPV0，计划在出生时接种）的接种时间。
在10175名儿童中（111个干预组中的5288名/111个对照组中的4887名），在7616人年的风险期内我们观察到265例死亡/住院（干预组：129例；对照组：136例）。C-OPV未降低复合终点，风险比（HR）：0.87，95%CI：0.68 - 1.12，也未降低其单独的组成部分。C-OPV降低了出生后<15天接种OPV0的儿童的风险（HR = 0.66，95%CI：0.46 - 0.95），但未降低其他儿童的风险（交互作用p值：0.03）。其他潜在效应修饰因素的交互作用无统计学意义。
C-OPV对死亡率/住院率无总体影响，但根据OPV0的早期启动情况其效果有所不同。
