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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Effect of human rotavirus vaccine on severe diarrhea in African infants
New England Journal of Medicine, Volume 362, No. 4, Year 2010
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Description
BACKGROUND: Rotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children. METHODS: We conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.1% of the total) and Malawi (1773 infants; 35.9% of the total) to evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis. Healthy infants were randomly assigned in a 1:1:1 ratio to receive two doses of vaccine (in addition to one dose of placebo) or three doses of vaccine - the pooled vaccine group - or three doses of placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were graded with the use of the Vesikari scale. RESULTS: A total of 4939 infants were enrolled and randomly assigned to one of the three groups; 1647 infants received two doses of the vaccine, 1651 infants received three doses of the vaccine, and 1641 received placebo. Of the 4417 infants included in the per-protocol efficacy analysis, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group and in 1.9% of those in the pooled vaccine group (vaccine efficacy, 61.2%; 95% confidence interval, 44.0 to 73.2). Vaccine efficacy was lower in Malawi than in South Africa (49.4% vs. 76.9%); however, the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa (6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year). Efficacy against all-cause severe gastroenteritis was 30.2%. At least one serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group. CONCLUSIONS: Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life. (ClinicalTrials.gov number, NCT00241644.) Copyright © 2010 Massachusetts Medical Society.
Authors & Co-Authors
Madhi, Shabir A.
South Africa, Johannesburg
University of the Witwatersrand
Cunliffe, Nigel A.
United Kingdom, Liverpool
University of Liverpool
Steele, Duncan A.
Switzerland, Geneva
Organisation Mondiale de la Santé
Witte, Desirée
United Kingdom, Liverpool
University of Liverpool
Malawi, Zomba
University of Malawi
Kirsten, Mari
South Africa, Pretoria
University of Pretoria
Louw, Cheryl Emily
South Africa
Madibeng Center for Research
South Africa, Sovenga
University of Limpopo
Ngwira, Bagrey M.M.
Malawi, Zomba
University of Malawi
Victor, John C.
United States, Seattle
Path Seattle
Gillard, P. H.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Cheuvart, Brigitte B.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Han, Htay Htay
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Neuzil, Kathleen Maletic
United States, Seattle
Path Seattle
Statistics
Citations: 215
Authors: 12
Affiliations: 9
Identifiers
Doi:
10.1056/NEJMoa0904797
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Health System And Policy
Maternal And Child Health
Study Design
Cohort Study
Study Locations
Malawi
South Africa