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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Human rotavirus vaccine Rotarix™ provides protection against diverse circulating rotavirus strains in African infants: a randomized controlled trial
BMC Infectious Diseases, Volume 12, Article 213, Year 2012
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Description
Background: Rotaviruses are the most important cause of severe acute gastroenteritis worldwide in children <5 years of age. The human, G1P[8] rotavirus vaccine Rotarix™ significantly reduced severe rotavirus gastroenteritis episodes in a Phase III clinical trial conducted in infants in South Africa and Malawi. This paper examines rotavirus vaccine efficacy in preventing severe rotavirus gastroenteritis, during infancy, caused by the various G and P rotavirus types encountered during the first rotavirus-season.Methods: Healthy infants aged 5-10 weeks were enrolled and randomized into three groups to receive either two (10 and 14 weeks) or three doses of Rotarix™ (together forming the pooled Rotarix™ group) or three doses of placebo at a 6,10,14-week schedule. Weekly home visits were conducted to identify gastroenteritis episodes. Rotaviruses were detected by ELISA and genotyped by RT-PCR and nucleotide sequencing. The percentage of infants with severe rotavirus gastroenteritis caused by the circulating G and P types from 2 weeks post-last dose until one year of age and the corresponding vaccine efficacy was calculated with 95% CI.Results: Overall, 4939 infants were vaccinated and 4417 (pooled Rotarix™ = 2974; placebo = 1443) were included in the per protocol efficacy cohort. G1 wild-type was detected in 23 (1.6%) severe rotavirus gastroenteritis episodes from the placebo group. This was followed in order of detection by G12 (15 [1%] in placebo) and G8 types (15 [1%] in placebo). Vaccine efficacy against G1 wild-type, G12 and G8 types were 64.1% (95% CI: 29.9%; 82%), 51.5% (95% CI:-6.5%; 77.9%) and 64.4% (95% CI: 17.1%; 85.2%), respectively. Genotype P[8] was the predominant circulating P type and was detected in 38 (2.6%) severe rotavirus gastroenteritis cases in placebo group. The remaining circulating P types comprised of P[4] (20 [1.4%] in placebo) and P[6] (13 [0.9%] in placebo). Vaccine efficacy against P[8] was 59.1% (95% CI: 32.8%; 75.3%), P[4] was 70.9% (95% CI: 37.5%; 87.0%) and P[6] was 55.2% (95% CI: -6.5%; 81.3%). Conclusions: Rotarix™ vaccine demonstrated efficacy against severe gastroenteritis caused by diverse circulating rotavirus types. These data add to a growing body of evidence supporting heterotypic protection provided by Rotarix™.Trial registration number: NCT00241644. © 2012 Steele et al.; licensee BioMed Central Ltd.
Authors & Co-Authors
Steele, Andrew Duncan
United States, Seattle
Path Seattle
Switzerland, Geneva
Organisation Mondiale de la Santé
Neuzil, Kathleen Maletic
United States, Seattle
Path Seattle
Cunliffe, Nigel A.
United Kingdom, Liverpool
University of Liverpool
Madhi, Shabir A.
South Africa, Johannesburg
National Institute for Communicable Diseases
South Africa, Johannesburg
University of the Witwatersrand
Bos, Pieter
South Africa, Sovenga
University of Limpopo
Ngwira, Bagrey M.M.
Malawi, Zomba
University of Malawi
Witte, Desirée
United Kingdom, Liverpool
University of Liverpool
Malawi, Zomba
University of Malawi
Todd, Stacy
United Kingdom, Liverpool
University of Liverpool
Louw, Cheryl Emily
South Africa, Brits
Madibeng Centre for Research
Kirsten, Mari
South Africa, Pretoria
University of Pretoria
Aspinall, Sanette
South Africa, Pretoria
Synexus Clinical Research Sa/rota Consortium
van Doorn, Leen Jan
Netherlands, Voorburg
Ddl Diagnostic Laboratory
Bouckenooghe, Alain R.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Suryakiran, Pemmaraju Venkata
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Han, Htay Htay
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Statistics
Citations: 131
Authors: 15
Affiliations: 12
Identifiers
Doi:
10.1186/1471-2334-12-213
e-ISSN:
14712334
Research Areas
Genetics And Genomics
Maternal And Child Health
Study Design
Cohort Study
Study Approach
Quantitative
Study Locations
Malawi
South Africa