1. Rotavirus vaccine 116E was shown to have similar efficacy to current vaccines RotaTeq and Rotarix in developing countries and may prove more sustainable in low-resource settings.
2. Protection against rotavirus gastroenteritis with vaccine 116E demonstrated positive correlation with severity of infection, suggesting that it may be a fitting option in resource-limited settings with high-disease burden of severe rotavirus gastroenteritis.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Rotavirus is the most common cause of severely dehydrating diarrhea in the developing world. Though access to affordable and effective vaccination against this virus is a crucial public health concern, sustainability is often challenging with the high price of current vaccines. This study aimed to assess the safety and efficacy of the newly developed 116E vaccine against severe rotavirus gastroenteritis in low-resource settings in India. Findings demonstrated that the 116E vaccine protected against gastroenteritis of varying severity, with protection increasing with severity of infection. Additionally, the 116E vaccine provided protection across a large array of common rotavirus genotypes in India, strongly suggesting that it could provide broad protection throughout other regions of the world. The 116E vaccine was found to have a similar point estimate of efficacy as existing vaccines RotaTeq and Rotarix in developing countries, but this comparison could be limited due to differing protocols, attack rates, study procedures and populations.
In-Depth [randomized, double-blind, placebo-controlled trial]: This study enrolled 6799 infants in a multicenter trial at three sites (1500 each in Pune and Vellore, and 3799 in Delhi). 4532 were randomly assigned to receive three doses of 116E vaccine (oral human-bovine natural reassortant) and 2267 were assigned to receive placebo per standard schedule. Severe rotavirus gastroenteritis had an incidence of 1.5 per 100 person-years in the vaccine group and 3.2 in the placebo group, with an incidence rate ratio of 0.46 (95% CI 0.33-0.65). The efficacy of the 116E vaccine against severe rotavirus gastroenteritis was 53.6% (95% CI 35.0-66.9; p=0.0013) and 56.4% (36.6-70.1; p<0.0001) during the first year of life. Efficacy for severe gastroenteritis of any cause was found to be 18.6%, and 24.1% in the first year of life, which demonstrated the significance of rotavirus as a cause of severe gastroenteritis in infants in India. Solicited, immediate, and serious adverse events had similar prevalence in both the vaccine and placebo groups.
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