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一剂口服霍乱死疫苗在刚果民主共和国流行地区的有效性:一项匹配病例对照研究。

Effectiveness of one dose of killed oral cholera vaccine in an endemic community in the Democratic Republic of the Congo: a matched case-control study.

机构信息

Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA; Centre for Tropical Diseases and Global Health (CTDGH), Université Catholique de Bukavu, Bukavu, Democratic Republic of the Congo.

Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK.

出版信息

Lancet Infect Dis. 2024 May;24(5):514-522. doi: 10.1016/S1473-3099(23)00742-9. Epub 2024 Jan 18.

Abstract

BACKGROUND

A global shortage of cholera vaccines has increased the use of single-dose regimens, rather than the standard two-dose regimen. There is sparse evidence on single-dose protection, particularly in children. In 2020, a mass vaccination campaign was conducted in Uvira, an endemic urban setting in eastern Democratic Republic of the Congo, resulting in largely single-dose coverage. We examined the effectiveness of a single-dose of the oral cholera vaccine Euvichol-Plus in this high-burden setting.

METHODS

In this matched case-control study, we recruited individuals with medically attended confirmed cholera in the two cholera treatment facilities in the city of Uvira. The control group consisted of age-matched, sex-matched, and neighbourhood-matched community individuals. We recruited across two distinct periods: Oct 14, 2021, to March 10, 2022 (12-17 months after vaccination), and Nov 21, 2022, to Oct 18, 2023 (24-36 months after vaccination). Study staff administered structured questionnaires to all participants to capture demographics, household conditions, potential confounding variables, and vaccination status. The odds of vaccination for the case and control groups were contrasted in conditional logistic regression models to estimate unadjusted and adjusted vaccine effectiveness.

FINDINGS

We enrolled 658 individuals with confirmed cholera and 2274 matched individuals for the control group. 99 (15·1%) individuals in the case group were younger than 5 years at the time of vaccination. The adjusted single-dose vaccine effectiveness was 52·7% (95% CI 31·4 to 67·4) 12-17 months after vaccination and 44·7% (24·8 to 59·4) 24-36 months after vaccination. Although protection in the first 12-17 months after vaccination was similar for children aged 1-4 years and older individuals, the estimate of protection in children aged 1-4 years appeared to wane during the third year after vaccination (adjusted vaccine effectiveness 32·9%, 95% CI -30·7 to 65·5), with CIs spanning the null.

INTERPRETATION

A single dose of Euvichol-Plus provided substantial protection against medically attended cholera for at least 36 months after vaccination in this cholera-endemic setting. Although the evidence provides support for similar levels of protection in young children and others in the short term, protection among children younger than 5 years might wane significantly during the third year after vaccination.

FUNDING

Wellcome Trust and Gavi, the Vaccine Alliance.

摘要

背景

全球霍乱疫苗短缺,导致更多地使用单剂方案,而非标准的两剂方案。关于单剂保护的证据很少,尤其是在儿童中。2020 年,在刚果民主共和国东部的一个流行城市乌维拉进行了一次大规模疫苗接种运动,结果主要是单剂接种。我们在这个高负担地区检验了口服霍乱疫苗 Euvichol-Plus 的单剂效果。

方法

在这项匹配病例对照研究中,我们招募了乌维拉市两家霍乱治疗中心中患有经医学证实的霍乱的个体。对照组由年龄、性别和社区相匹配的个体组成。我们在两个不同的时期进行了招募:2021 年 10 月 14 日至 2022 年 3 月 10 日(接种后 12-17 个月),以及 2022 年 11 月 21 日至 2023 年 10 月 18 日(接种后 24-36 个月)。研究人员通过结构化问卷向所有参与者询问人口统计学、家庭条件、潜在混杂变量和疫苗接种情况。在条件逻辑回归模型中对比病例组和对照组的疫苗接种几率,以估计未调整和调整后的疫苗有效性。

结果

我们共纳入了 658 名经医学证实患有霍乱的个体和 2274 名对照组个体。病例组中有 99 名(15.1%)个体在接种时年龄小于 5 岁。接种后 12-17 个月,单剂疫苗的调整后有效性为 52.7%(95%CI 31.4-67.4),接种后 24-36 个月,调整后有效性为 44.7%(24.8-59.4)。虽然在接种后 12-17 个月内,1-4 岁儿童和年龄较大的个体的保护作用相似,但在接种后第三年,儿童(1-4 岁)的保护作用似乎减弱(调整后疫苗有效性 32.9%,95%CI-30.7-65.5),置信区间接近零。

结论

在这个霍乱流行地区,Euvichol-Plus 的单剂接种为至少 36 个月内的医学性霍乱提供了实质性保护。尽管这一证据表明在短期内在幼儿和其他人群中提供了类似水平的保护,但在接种后第三年,5 岁以下儿童的保护作用可能会显著减弱。

资金来源

惠康基金会和全球疫苗免疫联盟(Gavi)。

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