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Published on: January 28, 2019
Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger
Sheila Isanaka1, Ousmane Guindo1, Celine Langendorf1
1From the Department of Research, Epicentre, Paris (S.I., C.L., R.F.G.); the Departments of Nutrition and Global Health and Population, Harvard T.H. Chan School of Public Health, Boston (S.I.); Epicentre (O.G., A.M.S., N.S.-M.), National Hospital (E.A.), and University of Niamey (A.D.), Niamey, Niger; BioStat Consulting, Jasper, GA (B.D.P.); Laboratory of Specialized Clinical Studies, Cincinnati Children's Hospital Medical Center, Cincinnati (M.M.M., N.M.); and Médecins sans Frontières Operational Center, Geneva (B.J.).
Insights
A rotavirus vaccine (BRV-PV) demonstrated 66.7% efficacy in preventing severe rotavirus gastroenteritis in infants in Niger. This oral vaccine offers a promising new tool to reduce child mortality from diarrhea in vulnerable regions.
Area of Science:
- Clinical Trials
- Vaccinology
- Pediatric Gastroenterology
Background:
- Rotavirus gastroenteritis causes significant mortality in children under 5 globally.
- Sub-Saharan Africa bears a disproportionate burden of rotavirus-related deaths.
Purpose of the Study:
- To evaluate the efficacy of a live, oral bovine rotavirus pentavalent vaccine (BRV-PV) against severe rotavirus gastroenteritis in infants.
- To assess the safety and tolerability of the BRV-PV vaccine in a randomized, placebo-controlled trial.
Main Methods:
- A randomized, placebo-controlled trial was conducted in Niger involving healthy infants.
- Infants received three doses of BRV-PV or placebo at 6, 10, and 14 weeks of age.
- Disease severity was assessed using the Vesikari scale, with severe gastroenteritis defined as a score of ≥11.
Main Results:
- Vaccine efficacy against severe rotavirus gastroenteritis was 66.7% (95% CI, 49.9 to 77.9) in the per-protocol analysis.
- Intention-to-treat analyses showed similar efficacy (69.1%; 95% CI, 55.0 to 78.7).
- Adverse event rates and serious adverse event rates were comparable between the vaccine and placebo groups; no intussusception was confirmed.
Conclusions:
- Three doses of the oral rotavirus vaccine BRV-PV demonstrated significant efficacy in preventing severe rotavirus gastroenteritis in infants in Niger.
- The vaccine was well-tolerated, with no significant safety concerns identified compared to placebo.
- BRV-PV represents a potentially crucial intervention for reducing rotavirus disease burden in low-resource settings.
Background:
Each year, rotavirus gastroenteritis is responsible for about 37% of deaths from diarrhea among children younger than 5 years of age worldwide, with a disproportionate effect in sub-Saharan Africa.
Methods:
We conducted a randomized, placebo-controlled trial in Niger to evaluate the efficacy of a live, oral bovine rotavirus pentavalent vaccine (BRV-PV, Serum Institute of India) to prevent severe rotavirus gastroenteritis. Healthy infants received three doses of the vaccine or placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis were assessed through active and passive surveillance and were graded on the basis of the score on the Vesikari scale (which ranges from 0 to 20, with higher scores indicating more severe disease). The primary end point was the efficacy of three doses of vaccine as compared with placebo against a first episode of laboratory-confirmed severe rotavirus gastroenteritis (Vesikari score, ≥11) beginning 28 days after dose 3.
Results:
Among the 3508 infants who were included in the per-protocol efficacy analysis, there were 31 cases of severe rotavirus gastroenteritis in the vaccine group and 87 cases in the placebo group (2.14 and 6.44 cases per 100 person-years, respectively), for a vaccine efficacy of 66.7% (95% confidence interval [CI], 49.9 to 77.9). Similar efficacy was seen in the intention-to-treat analyses, which showed a vaccine efficacy of 69.1% (95% CI, 55.0 to 78.7). There was no significant between-group difference in the risk of adverse events, which were reported in 68.7% of the infants in the vaccine group and in 67.2% of those in the placebo group, or in the risk of serious adverse events (in 8.3% in the vaccine group and in 9.1% in the placebo group); there were 27 deaths in the vaccine group and 22 in the placebo group. None of the infants had confirmed intussusception.
Conclusions:
Three doses of BRV-PV, an oral rotavirus vaccine, had an efficacy of 66.7% against severe rotavirus gastroenteritis among infants in Niger. (Funded by Médecins sans Frontières Operational Center and the Kavli Foundation; ClinicalTrials.gov number, NCT02145000 .).
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