Effect of a campaign with oral polio vaccine on general health: A cluster-randomised trial in rural Guinea-Bissau

IF 14.3 1区 医学 Q1 INFECTIOUS DISEASES Journal of Infection Pub Date : 2024-09-30 DOI:10.1016/j.jinf.2024.106302
Line M. Nanque , Anshu Varma , Sanne M. Thysen , Christine S. Benn , Justiniano SD Martins , Aksel KG Jensen , Claudino Correia , Sören Möller , Anita Van den Biggelaar , Peter Aaby , Ane B. Fisker
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Abstract

Objectives

To investigate in a cluster-randomised trial whether a campaign with oral polio vaccine (C-OPV) reduced mortality and morbidity.

Methods

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.

Results

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.

Conclusions

C-OPV had no overall effect on mortality/admissions, but the effect differed by early priming with OPV0.
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口服脊髓灰质炎疫苗运动对总体健康的影响:几内亚比绍农村地区的分组随机试验。
目的通过分组随机试验调查口服脊髓灰质炎疫苗(C-OPV)是否能降低死亡率和发病率:我们将 222 个接受人口监测的村庄集群随机分为干预组(健康检查和 C-OPV)或对照组(仅健康检查)。0-8个月大的儿童均符合条件。在以年龄为基本时间尺度的 Cox 比例危险模型中,我们比较了 12 个月随访期间的非意外死亡率/入院率(综合主要结果)。二次分析将非意外入院率和死亡率作为单独的结果。我们还评估了先前研究中发现的潜在影响因素,包括性别、季节和首次常规接种 OPV 的时间(OPV0,计划在出生时接种):在 10,175 名儿童(111 个干预群组中的 5,288 人/111 个对照群组中的 4,887 人)中,我们观察到在 7,616 个风险年中有 265 人死亡/入院(干预群组:129 人;对照群组:136 人)。C-OPV 没有降低综合终点(危险比 (HR):0.87,95%CI:0.68-1.12)或其单独组成部分。结论:C-OPV降低了接受OPV的儿童的风险:结论:C-OPV对死亡率/入院率没有总体影响,但效果因早期接种OPV0而异。
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来源期刊
Journal of Infection
Journal of Infection 医学-传染病学
CiteScore
45.90
自引率
3.20%
发文量
475
审稿时长
16 days
期刊介绍: The Journal of Infection publishes original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in the ever-changing field of infection. Each issue brings you Editorials that describe current or controversial topics of interest, high quality Reviews to keep you in touch with the latest developments in specific fields of interest, an Epidemiology section reporting studies in the hospital and the general community, and a lively correspondence section.
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