Benefit of rotavirus vaccine against severe gastroenteritis in developing countries

January 01, 0001

Benefit of rotavirus vaccine against severe gastroenteritis in developing countries

Rotavirus vaccine has proved effective for prevention of severe rotavirus gastroenteritis in infants in developed countries, but no efficacy studies have been done in developing countries in Asia. The researchers from Bangladesh, Vietnam the USA, Korea and Switzerland assessed the clinical efficacy of live oral pentavalent rotavirus vaccine for prevention of severe rotavirus gastroenteritis in infants in Bangladesh and Vietnam. In this multicentre, double-blind, placebo-controlled trial, undertaken in rural Matlab, Bangladesh, and urban and periurban Nha Trang, Vietnam, infants aged 4—12 weeks without symptoms of gastrointestinal disorders were randomly assigned (1:1) to receive three oral doses of pentavalent rotavirus vaccine 2 mL or placebo at around 6 weeks, 10 weeks, and 14 weeks of age, in conjunction with routine infant vaccines including oral poliovirus vaccine. Episodes of gastroenteritis in infants who presented to study medical facilities were reported by clinical staff and from parent recollection. 2036 infants were randomly assigned to receive pentavalent rotavirus vaccine (n=1018) or placebo (n=1018). 991 infants assigned to pentavalent rotavirus vaccine and 978 assigned to placebo were included in the per-protocol analysis. Median follow up from 14 days after the third dose of placebo or vaccine until final disposition was 498 days.

38 cases of severe rotavirus gastroenteritis were reported during more than 1197 person-years of follow up in the vaccine group, compared with 71 cases in more than 1156 person years in the placebo group, resulting in a vaccine efficacy of 48.3% against severe disease during nearly 2 years of follow-up. 2.5% of 1017 infants assigned to receive vaccine and 2.0% of 1018 assigned to receive placebo had a serious adverse event within 14 days of any dose. The most frequent serious adverse event was pneumonia (vaccine 1.2%; placebo 1.5%).

The researchers concluded: "In infants in developing countries in Asia, pentavalent rotavirus vaccine is safe and efficacious against severe rotavirus gastroenteritis, and our results support expanded WHO recommendations to promote its global use."

This does appear to have had an important impact.

For the full abstract, click here.

The Lancet 376(9741):615-623, 21 August 2010 © 2010 Elsevier Limited
Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. K Zaman, Dang Duc Anh, John C Victor, et al. Correspondence to John C Victor: [email protected]

Category: Keywords: rotavirus, pentavalent, vaccine, efficacy, gastroenteritis, infants, developing countries, Asia, randomised, double-blind, placebo-controlled trial, journal watch.
Synopsis edited by Dr Stephen Wilkinson, Melbourne, Australia. Posted on Global Family Doctor 15 October 2010

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