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基于 III 期个体化数据的贝叶斯生存分析揭示 CYD-TDV 登革热疫苗的疗效特征。

Efficacy profile of the CYD-TDV dengue vaccine revealed by Bayesian survival analysis of individual-level phase III data.

机构信息

MRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, Faculty of Medicine, London, United Kingdom.

Sanofi Pasteur, Lyon, France.

出版信息

Elife. 2021 Jul 2;10:e65131. doi: 10.7554/eLife.65131.

DOI:10.7554/eLife.65131
PMID:34219653
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8321579/
Abstract

BACKGROUND

Sanofi-Pasteur's CYD-TDV is the only licensed dengue vaccine. Two phase three trials showed higher efficacy in seropositive than seronegative recipients. Hospital follow-up revealed increased hospitalisation in 2-5- year-old vaccinees, where serostatus and age effects were unresolved.

METHODS

We fit a survival model to individual-level data from both trials, including year 1 of hospital follow-up. We determine efficacy by age, serostatus, serotype and severity, and examine efficacy duration and vaccine action mechanism.

RESULTS

Our modelling indicates that vaccine-induced immunity is long-lived in seropositive recipients, and therefore that vaccinating seropositives gives higher protection than two natural infections. Long-term increased hospitalisation risk outweighs short-lived immunity in seronegatives. Independently of serostatus, transient immunity increases with age, and is highest against serotype 4. Benefit is higher in seropositives, and risk enhancement is greater in seronegatives, against hospitalised disease than against febrile disease.

CONCLUSIONS

Our results support vaccinating seropositives only. Rapid diagnostic tests would enable viable 'screen-then-vaccinate' programs. Since CYD-TDV acts as a silent infection, long-term safety of other vaccine candidates must be closely monitored.

FUNDING

Bill & Melinda Gates Foundation, National Institute for Health Research, UK Medical Research Council, Wellcome Trust, Royal Society.

CLINICAL TRIAL NUMBER

NCT01373281 and NCT01374516.

摘要

背景

赛诺菲巴斯德的 CYD-TDV 是唯一获得许可的登革热疫苗。两项三期临床试验表明，在血清阳性者中的疗效高于血清阴性者。医院随访发现，2-5 岁疫苗接种者的住院率增加，而血清状态和年龄效应尚未得到解决。

方法

我们根据两项试验的个体水平数据拟合生存模型，包括医院随访的第 1 年。我们按年龄、血清状态、血清型和严重程度确定疗效，并检查疗效持续时间和疫苗作用机制。

结果

我们的模型表明，疫苗诱导的免疫在血清阳性者中具有长期持久性，因此接种血清阳性者比两次自然感染提供更高的保护。血清阴性者的长期住院风险增加超过了短暂的免疫力。与血清状态无关，短暂的免疫力随年龄增长而增加，对血清型 4 的免疫力最高。对住院疾病的益处高于发热疾病，对血清阳性者的益处更高，对血清阴性者的风险增强更大。

结论

我们的结果支持仅对血清阳性者进行接种。快速诊断测试将使可行的“筛查后接种”计划成为可能。由于 CYD-TDV 作为一种隐性感染，必须密切监测其他候选疫苗的长期安全性。

资金来源

比尔及梅林达·盖茨基金会、英国国家卫生研究院、英国医学研究理事会、惠康信托基金会、英国皇家学会。

临床试验编号

NCT01373281 和 NCT01374516。

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10
Global Advisory Committee on Vaccine Safety, 6–7 December 2017.全球疫苗安全咨询委员会，2017年12月6日至7日。
Wkly Epidemiol Rec. 2018 Jan 19;93(2):17-30.