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Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger

Thursday, 25th of May 2017

Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger

Sheila Isanaka, Sc.D., Ousmane Guindo, M.D., Celine Langendorf, Pharm.D., M.P.H., Amadou Matar Seck, M.D., Brian D. Plikaytis, M.Sc., Nathan Sayinzoga-Makombe, M.P.H., Monica M. McNeal, M.Sc., Nicole Meyer, M.Sc., Eric Adehossi, M.D., Ali Djibo, M.D., Bruno Jochum, M.S., and Rebecca F. Grais, Ph.D.

N Engl J Med 2017; 376:1121-1130March 23, 2017DOI: 10.1056/NEJMoa1609462

Abstract below; full text is at http://www.nejm.org/doi/full/10.1056/NEJMoa1609462#t=article

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.)