A multi-country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: Rationale and design

Camilo J. Acosta, Claudia M. Galindo, Mohammad Ali, Remon Abu Elyazeed, R. Leon Ochiai, M. Carolina Danovaro-Holliday, Anne Laure Page, Vu Dinh Thiem, Yang Jin, Jin Kyung Park, Hyejon Lee, Mahesh K. Puri, Bernard Ivanoff, Magdarina D. Agtini, Rooswanti Soeharno, Cyrus H. Simanjuntak, Narain H. Punjabi, Do Gia Canh, Dipika Sur, Qamaruddin NizamiByomkesh Manna, Dong Bai-Qing, Dang Due Anh, Yang Honghui, Sujit Kumar Bhattacharya, Zulfikar Bhutta, Dang Duc Trach, Zhi Yi Xu, Tikki Pang, Allan Donner, John D. Clemens

Research output: Contribution to journalArticlepeer-review

Abstract

Phase-III vaccine efficacy trials typically employ individually randomized designs intended to ensure that measurements of vaccine protective efficacy reflect only direct vaccine effects. As a result, decisions about introducing newly licensed vaccines into public health programmes often fail to consider the substantially greater protection that may occur when a vaccine is deployed in public health programmes, due to the combination of direct plus indirect vaccine protective effects. Vaccine total protection can be better evaluated with cluster randomized trials. Such a design was considered to generate policy relevant data to accelerate the rationale introduction of the licensed typhoid fever Vi polysaccharide (PS) vaccine in Asia by the Diseases of the Most Impoverished (DOMI) typhoid fever programme. The DOMI's programme multi-country study is one of the largest cluster randomized vaccine trials ever mounted in Asia, which includes approximately 200 000 individuals. Its main objective is to determine the effectiveness of a licensed Vi PS vaccine. The rationale and design of this study are discussed. Preliminary results are presented that determined the final planning of the trial before immunization. Important methodological and practical issues regarding vaccine cluster randomized designs are illustrated.

Original languageEnglish (US)
Pages (from-to)1219-1228
Number of pages10
JournalTropical Medicine and International Health
Volume10
Issue number12
DOIs
StatePublished - Dec 2005

Keywords

  • Effectiveness trial
  • Typhoid fever
  • Vi polysaccharide vaccine

ASJC Scopus subject areas

  • Parasitology
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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