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

Hdl Handle:
http://hdl.handle.net/10144/618874
Title:
Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger
Authors:
Isanaka, S; Guindo, O; Langendorf, C; Matar Seck, A; Plikaytis, BD; Sayinzoga-Makombe, N; McNeal, MM; Meyer, N; Adehossi, E; Djibo, A; Jochum, B; Grais, RF
Journal:
The New England Journal of Medicine
Abstract:
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 .).
Publisher:
Massachusetts Medical Society
Issue Date:
23-Mar-2017
URI:
http://hdl.handle.net/10144/618874
DOI:
10.1056/NEJMoa1609462
PubMed ID:
28328346
Submitted date:
2017-03-29
Language:
en
ISSN:
1533-4406
Appears in Collections:
Vaccination

Full metadata record

DC FieldValue Language
dc.contributor.authorIsanaka, Sen
dc.contributor.authorGuindo, Oen
dc.contributor.authorLangendorf, Cen
dc.contributor.authorMatar Seck, Aen
dc.contributor.authorPlikaytis, BDen
dc.contributor.authorSayinzoga-Makombe, Nen
dc.contributor.authorMcNeal, MMen
dc.contributor.authorMeyer, Nen
dc.contributor.authorAdehossi, Een
dc.contributor.authorDjibo, Aen
dc.contributor.authorJochum, Ben
dc.contributor.authorGrais, RFen
dc.date.accessioned2017-03-30T13:29:24Z-
dc.date.available2017-03-30T13:29:24Z-
dc.date.issued2017-03-23-
dc.date.submitted2017-03-29-
dc.identifier.citationEfficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger. 2017, 376 (12):1121-1130 N. Engl. J. Med.en
dc.identifier.issn1533-4406-
dc.identifier.pmid28328346-
dc.identifier.doi10.1056/NEJMoa1609462-
dc.identifier.urihttp://hdl.handle.net/10144/618874-
dc.description.abstractBackground 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 .).en
dc.language.isoenen
dc.publisherMassachusetts Medical Societyen
dc.rightsArchived with thanks to The New England Journal of Medicine.en
dc.titleEfficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Nigeren
dc.identifier.journalThe New England Journal of Medicineen

Related articles on PubMed

All Items in MSF are protected by copyright, with all rights reserved, unless otherwise indicated.