作者
Arunee Sabchareon, Derek Wallace, Chukiat Sirivichayakul, Kriengsak Limkittikul, Pornthep Chanthavanich, Saravudh Suvannadabba, Vithaya Jiwariyavej, Wut Dulyachai, Krisana Pengsaa, T Anh Wartel, Annick Moureau, Melanie Saville, Alain Bouckenooghe, Simonetta Viviani, Nadia G Tornieporth, Jean Lang
发表日期
2012/11/3
期刊
The Lancet
卷号
380
期号
9853
页码范围
1559-1567
出版商
Elsevier
简介
Background
Roughly half the world's population live in dengue-endemic countries, but no vaccine is licensed. We investigated the efficacy of a recombinant, live, attenuated tetravalent dengue vaccine.
Methods
In this observer-masked, randomised, controlled, monocentre, phase 2b, proof-of-concept trial, healthy Thai schoolchildren aged 4–11 years were randomly assigned (2:1) to receive three injections of dengue vaccine or control (rabies vaccine or placebo) at months 0, 6, and 12. Randomisation was by computer-generated permuted blocks of six and participants were assigned with an interactive response system. Participants were actively followed up until month 25. All acute febrile illnesses were investigated. Dengue viraemia was confirmed by serotype-specific RT-PCR and non-structural protein 1 ELISA. The primary objective was to assess protective efficacy against virologically confirmed, symptomatic …
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A Sabchareon, D Wallace, C Sirivichayakul… - The Lancet, 2012