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一剂口服霍乱疫苗对疫情的有效性:病例对照研究。

Effectiveness of one dose of oral cholera vaccine in response to an outbreak: a case-cohort study.

机构信息

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Médecins Sans Frontières, Geneva, Switzerland.

Médecins Sans Frontières, Geneva, Switzerland; CIBER Epidemiología y Salud Pública, Universidad Miguel Hernández, Alicante, Spain.

出版信息

Lancet Glob Health. 2016 Nov;4(11):e856-e863. doi: 10.1016/S2214-109X(16)30211-X.

Abstract

BACKGROUND

Oral cholera vaccines represent a new effective tool to fight cholera and are licensed as two-dose regimens with 2-4 weeks between doses. Evidence from previous studies suggests that a single dose of oral cholera vaccine might provide substantial direct protection against cholera. During a cholera outbreak in May, 2015, in Juba, South Sudan, the Ministry of Health, Médecins Sans Frontières, and partners engaged in the first field deployment of a single dose of oral cholera vaccine to enhance the outbreak response. We did a vaccine effectiveness study in conjunction with this large public health intervention.

METHODS

We did a case-cohort study, combining information on the vaccination status and disease outcomes from a random cohort recruited from throughout the city of Juba with that from all the cases detected. Eligible cases were those aged 1 year or older on the first day of the vaccination campaign who sought care for diarrhoea at all three cholera treatment centres and seven rehydration posts throughout Juba. Confirmed cases were suspected cases who tested positive to PCR for Vibrio cholerae O1. We estimated the short-term protection (direct and indirect) conferred by one dose of cholera vaccine (Shanchol, Shantha Biotechnics, Hyderabad, India).

FINDINGS

Between Aug 9, 2015, and Sept 29, 2015, we enrolled 87 individuals with suspected cholera, and an 898-person cohort from throughout Juba. Of the 87 individuals with suspected cholera, 34 were classified as cholera positive, 52 as cholera negative, and one had indeterminate results. Of the 858 cohort members who completed a follow-up visit, none developed clinical cholera during follow-up. The unadjusted single-dose vaccine effectiveness was 80·2% (95% CI 61·5-100·0) and after adjusting for potential confounders was 87·3% (70·2-100·0).

INTERPRETATION

One dose of Shanchol was effective in preventing medically attended cholera in this study. These results support the use of a single-dose strategy in outbreaks in similar epidemiological settings.

FUNDING

Médecins Sans Frontières.

摘要

背景

口服霍乱疫苗是一种新的有效抗击霍乱的工具,已被批准作为两剂方案使用,两剂之间间隔 2-4 周。先前研究的证据表明,一剂口服霍乱疫苗可能会对霍乱提供实质性的直接保护。在 2015 年 5 月南苏丹朱巴的一次霍乱疫情中,卫生部、无国界医生组织和合作伙伴首次在现场部署了一剂口服霍乱疫苗,以加强疫情应对。我们结合这项大规模公共卫生干预措施开展了疫苗效力研究。

方法

我们进行了病例对照研究,将随机从朱巴全市招募的一个对照人群的疫苗接种情况和疾病结果信息与所有在朱巴发现的病例相结合。合格病例是指在疫苗接种活动的第一天年龄在 1 岁或以上、在朱巴的所有三个霍乱治疗中心和七个补液站因腹泻寻求治疗的人。确诊病例是指 PCR 检测霍乱弧菌 O1 阳性的疑似病例。我们估计了一剂霍乱疫苗(印度海得拉巴的 Shantha Biotechnics 公司生产的 Shanchol)带来的短期保护(直接和间接)。

结果

2015 年 8 月 9 日至 9 月 29 日,我们纳入了 87 名疑似霍乱患者和 898 名来自朱巴各地的对照人群。在 87 名疑似霍乱患者中,34 名被分类为霍乱阳性,52 名被分类为霍乱阴性,1 名结果不确定。在完成随访的 858 名对照人群成员中,无人在随访期间出现临床霍乱。未经调整的一剂疫苗效力为 80.2%(95%CI 61.5-100.0),调整潜在混杂因素后为 87.3%(70.2-100.0)。

解释

在这项研究中,一剂 Shanchol 对预防有医疗记录的霍乱是有效的。这些结果支持在类似流行病学环境下的疫情中使用一剂策略。

资助

无国界医生组织。

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