Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger
| Autor: | Ali Djibo, Ousmane Guindo, Sheila Isanaka, Brian D. Plikaytis, Nathan Sayinzoga-Makombe, Monica M. McNeal, Bruno Jochum, Nicole Meyer, Eric Adehossi, Amadou Matar Seck, Rebecca F. Grais, Céline Langendorf |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Male
Rotavirus 0301 basic medicine Pediatrics medicine.medical_specialty Administration Oral Kaplan-Meier Estimate Vaccines Attenuated medicine.disease_cause Placebo Rotavirus Infections law.invention Pentavalent vaccine Feces 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law medicine Animals Humans Niger 030212 general & internal medicine First episode business.industry Incidence Incidence (epidemiology) Rotavirus Vaccines Infant General Medicine Rotavirus vaccine Gastroenteritis Diarrhea 030104 developmental biology Immunology Cattle Female medicine.symptom business |
| Zdroj: | New England Journal of Medicine. 376:1121-1130 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa1609462 |
| Popis: | 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.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.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.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 .). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|