Efficacy of a Low-Cost, Heat-Stable Rotavirus Vaccine

Efficacy of a Low-Cost, Heat-Stable Rotavirus Vaccine


Rotavirus is the leading cause of severe gastroenteritis
among young children. The two currently approved oral rotavirus
vaccines require refrigeration, which makes transportation and storage difficult, especially
in resource-constrained areas such as sub-Saharan Africa, which has the highest burden of rotavirus-related
mortality. BRV-PV is a live attenuated vaccine containing
5 rotavirus serotypes that is stable for two years at temperatures as high as 37 degrees
Celsius. In a double-blind, randomized, phase III trial
conducted in Niger, investigators randomized 4092 healthy infants to receive three doses
of either BRV-PV or placebo. In a per-protocol analysis of children who
received all three doses, the number of cases of severe rotavirus gastroenteritis was 2.14
per 100 person-years in the vaccine group versus 6.44 per 100 person-years in the placebo
group. Vaccination prevented 4.3 episodes of severe
rotavirus gastroenteritis per 100 person-years, a vaccine efficacy rate of 66.7%. Rates of severe adverse events, hospitalization and overall
mortality were not statistically different between the vaccine and placebo groups. No confirmed cases of intussusception were reported. The authors conclude that BRV-PV, a heat-stable
rotavirus vaccine, was protective against severe rotavirus gastroenteritis among infants
in Niger. Full trial results are available at NEJM.org.

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