Efficacy of a bivalent killed whole-cell cholera vaccine over five years: a re-analysis of a cluster-randomized trial.
Efficacy of a bivalent killed whole-cell cholera vaccine over five years: a re-analysis of a cluster-randomized trial.
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DOI：
10.1186/s12879-018-2981-4
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发表时间：
2018-02-20
影响因子：
3.7
通讯作者：
Chao DL
中科院分区：
文献类型：
--
作者：
Fong Y;Halloran ME;Park JK;Marks F;Clemens JD;Chao DL
口服霍乱疫苗（OCV）是预防或减轻霍乱暴发的可行工具。更好地了解疫苗在不同年龄组中的有效性以及其保护作用减弱的速度可以帮助指导疫苗接种政策。为了估计OCV疗效的水平和持续时间，我们重新分析了先前发表的随机分组、双盲、安慰剂对照试验的数据，随访5年。我们使用了考克斯比例风险模型，并模拟了年龄类别对安慰剂组疫苗有效性和感染风险的潜在时间依赖性影响。此外，我们研究了爆发期对模型估计的影响。1岁至5岁以下儿童的疫苗有效性为38%（95% CI：-2%，62%），5岁至15岁以下儿童的疫苗有效性为85%（95% CI：67%，93%），15岁及以上儿童的疫苗有效性为69%（95% CI：49%，81%）。在成人疫苗接种者中，效力在试验期间似乎没有减弱，但没有足够的数据来评估儿童疫苗接种者中效力的减弱。通过该再分析，我们能够检测到5岁以下儿童接种疫苗与5岁及以上儿童接种疫苗时OCV疗效的统计学显著差异。与基于所有5年的分析相比，估计的有效性与先前发表的基于前2年随访的分析更相似。ClinicalTrials.gov标识符NCT 00289224本文的在线版本（10.1186/s12879-018-2981-4）包含补充材料，授权用户可以使用。
Oral cholera vaccine (OCV) is a feasible tool to prevent or mitigate cholera outbreaks. A better understanding of the vaccine’s efficacy among different age groups and how rapidly its protection wanes could help guide vaccination policy. To estimate the level and duration of OCV efficacy, we re-analyzed data from a previously published cluster-randomized, double-blind, placebo controlled trial with five years of follow-up. We used a Cox proportional hazards model and modeled the potentially time-dependent effect of age categories on both vaccine efficacy and risk of infection in the placebo group. In addition, we investigated the impact of an outbreak period on model estimation. Vaccine efficacy was 38% (95% CI: -2%,62%) for those vaccinated from ages 1 to under 5 years old, 85% (95% CI: 67%,93%) for those 5 to under 15 years, and 69% (95% CI: 49%,81%) for those vaccinated at ages 15 years and older. Among adult vaccinees, efficacy did not appear to wane during the trial, but there was insufficient data to assess the waning of efficacy among child vaccinees. Through this re-analysis we were able to detect a statistically significant difference in OCV efficacy when the vaccine was administered to children under 5 years old vs. children 5 years and older. The estimated efficacies are more similar to the previously published analysis based on the first two years of follow-up than the analysis based on all five years. ClinicalTrials.gov identifier NCT00289224 The online version of this article (10.1186/s12879-018-2981-4) contains supplementary material, which is available to authorized users.
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