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Effect of human rotavirus vaccine on severe diarrhea in African infants
Shabir A Madhi1, Nigel A Cunliffe2, Duncan Steele3
1Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa.
Insights
The rotavirus vaccine significantly reduced severe gastroenteritis in African infants. This live, oral vaccine demonstrated 61.2% efficacy against rotavirus gastroenteritis in a trial across South Africa and Malawi.
Area of Science:
- Pediatrics
- Vaccinology
- Infectious Diseases
Background:
- Rotavirus is a leading cause of severe gastroenteritis in young children globally.
- There is a need for data on rotavirus vaccine efficacy in African infants.
Purpose of the Study:
- To evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis in African infants.
- To assess vaccine efficacy in South Africa and Malawi.
Main Methods:
- A randomized, placebo-controlled, multicenter trial was conducted in South Africa and Malawi.
- 4939 infants were assigned to receive two vaccine doses, three vaccine doses, or placebo.
- Infants were followed for one year, with gastroenteritis episodes graded using the Vesikari scale.
Main Results:
- The pooled vaccine group showed 61.2% efficacy against severe rotavirus gastroenteritis (95% CI, 44.0 to 73.2).
- Vaccine efficacy varied between countries (76.9% in South Africa, 49.4% in Malawi), but more cases were prevented per capita in Malawi.
- Efficacy against all-cause severe gastroenteritis was 30.2%; serious adverse events were similar between groups.
Conclusions:
- The human rotavirus vaccine significantly reduced severe rotavirus gastroenteritis incidence in African infants.
- The findings support the use of rotavirus vaccination programs in African countries to reduce childhood gastroenteritis.
Background:
Rotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children.
Methods:
We conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.1% of the total) and Malawi (1773 infants; 35.9% of the total) to evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis. Healthy infants were randomly assigned in a 1:1:1 ratio to receive two doses of vaccine (in addition to one dose of placebo) or three doses of vaccine - the pooled vaccine group - or three doses of placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were graded with the use of the Vesikari scale.
Results:
A total of 4939 infants were enrolled and randomly assigned to one of the three groups; 1647 infants received two doses of the vaccine, 1651 infants received three doses of the vaccine, and 1641 received placebo. Of the 4417 infants included in the per-protocol efficacy analysis, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group and in 1.9% of those in the pooled vaccine group (vaccine efficacy, 61.2%; 95% confidence interval, 44.0 to 73.2). Vaccine efficacy was lower in Malawi than in South Africa (49.4% vs. 76.9%); however, the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa (6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year). Efficacy against all-cause severe gastroenteritis was 30.2%. At least one serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group.
Conclusions:
Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life. (ClinicalTrials.gov number, NCT00241644.).
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