Robert S. Baltimore, MD reviewing Isanaka S et al. N Engl J Med 2017 Mar 23. Santosham M and Steele D. N Engl J Med 2017 Mar 23.

Vaccine efficacy was 66.7% at preventing first-episode rotavirus gastroenteritis in Nigerian infants.

Prior to the development of current oral rotavirus vaccines, rotavirus was the leading cause of severe gastroenteritis in young children worldwide. It is still a major cause of severe gastroenteritis in the developing world, and sub-Saharan Africa has the highest rate of death associated with rotavirus infection. Barriers to the use of existing oral rotavirus vaccines in the developing world are the high cost of the vaccines and the difficulty of maintaining the cold chain from production to vaccination.

Now, international investigators have conducted a double-blind, placebo-controlled, randomized, phase III trial of a pentavalent live oral rotavirus vaccine. The bovine-human reassortant vaccine contains rotavirus serotypes G1–G4 and G9 and is stable for 2 years at 37°C and for 6 months at 40°C. The editorial states that at $3.00 per course, it undercuts currently approved vaccines. A total of 3508 Nigerian infants were randomized approximately 1:1 to receive the vaccine or placebo. The primary endpoint was occurrence of a first episode of laboratory-confirmed rotavirus gastroenteritis in the 28 days following the third vaccine dose.

Fewer cases of severe rotavirus gastroenteritis occurred in the vaccine group than in the placebo group (31 vs. 87), for a vaccine efficacy of 66.7%, which is good, considering that trials of existing rotavirus vaccines in the developing world show lower efficacy than in wealthy countries. Efficacy was also higher with the vaccine for prevention of more severe gastroenteritis. No safety issues or cases of intussusception were observed in either group.

CITATION(S):

Isanaka S et al. Efficacy of a low-cost, heat-stable oral rotavirus vaccine in Niger. N Engl J Med 2017 Mar 23; 376:1121.

Santosham M and Steele D.Rotavirus vaccines — A new hope. N Engl J Med 2017 Mar 23; 376:1170. 

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