Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trialArchived
These article published in The Lancet provide new data for the efficacy of oral pentavalent rotavirus vaccine for prevention of severe rotavirus – related gastroenteritis in infant in developing countries. Armah GE et al. The Lancet 2010 (376); 9741: 606-614 Zaman K et al. The Lancet 2010 (376); 9741: 615-623
Armah GE et al. The Lancet 2010 (376); 9741: 606-614; Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial
Zaman K et al. The Lancet 2010 (376); 9741: 615-62; Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial
Description: In 2006, WHO advocated use of currently licensed rotavirus vaccines in European and Americas regions, where efficacy data had been generated, and recommended that rotavirus efficacy trials be done in Africa and Asia. These two articles published in The Lancet provide new data on the efficacy of oral pentavalent rotavirus vaccine for prevention of severe rotavirus – related gastroenteritis in infant in developing countries. These randomised, double-blind, placebo-controlled trials, undertaken in Ghana, Kenya, Mali, Bangladesh and Vietnam, enrolled over 7000 eligible infants between 4 weeks and 12 weeks of age, in urban and rural settings. Three oral doses of pentavalent rotavirus vaccine 2 mL or placebo were given at 6 weeks, 10 weeks and 14 weeks of age. Study design and analysis was identical in both studies. Over two years, vaccine efficacy against severe rotavirus gastroenteritis was lower in the African countries (39.3%, 95% CI 19.1-54.7) than in the Asian countries (48.3%, 95% CI 22.3-66.1). Both studies reported that estimates of efficacy were lower than that reported in developed countries. Decline in efficacy from the first to the second year of life was noted. This decline of efficacy should not detract from the benefit of the rotavirus vaccine implementation in countries with high mortality from diarrhoea. Further research are needed to understand why the efficacy of live oral rotavirus vaccines is lower among children in low-income countries than high-income countries.
Disclosure statement: In both studies, funding was provided by PATH (GAVI Alliance grant) and Merck. Several authors are employees of Merck. All other authors declared no conflict of interest.