Efficacy, immunogenicity, and safety of two doses of a tetravalent rotavirus vaccine RRV-TV in Ghana with the first dose administered during the neonatal period
dc.contributor.author | Armah, G.E. | |
dc.contributor.author | Kapikian, A.Z. | |
dc.contributor.author | Vesikari, T. | |
dc.contributor.author | Cunliffe, N. | |
dc.contributor.author | Jacobson, R.M. | |
dc.contributor.author | Burlington, D.B. | |
dc.contributor.author | Ruiz, Jr. L.P. | |
dc.date.accessioned | 2018-12-11T15:02:39Z | |
dc.date.available | 2018-12-11T15:02:39Z | |
dc.date.issued | 2013-08 | |
dc.description.abstract | Background. Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age. This study examined RRV-TV for the prevention of rotavirus gastroenteritis (RV-GE) in Ghana, West Africa, with infants receiving the first dose during the neonatal period and the second before 60 days of age.Methods. In a double-blinded, randomized, placebo-controlled trial in Navrongo, Ghana, we recruited neonates to receive 2 doses of RRV-TV or placebo and followed them to age 12 months.Results. In the intention-to-treat population of 998 infants, we measured a vaccine efficacy of 63.1% against RV-GE of any severity associated with any of the 4 serotypes represented in the vaccine and 60.7% against RV-GE associated with any rotavirus serotype.Conclusions. RRV-TV in a 2-dose schedule with the first dose during the neonatal period is efficacious in preventing RV-GE in rural Ghana. Neonatal dosing results in early protection and may be the optimum schedule to avoid or significantly reduce intussusception, now reported to be associated in international settings with the 2 most widely marketed, licensed, live virus, oral rotavirus vaccines. © 2013 The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. | en_US |
dc.identifier.other | https://doi.org/10.1093/infdis/jit174 | |
dc.identifier.other | Vol. 208(3): pp 423-431 | |
dc.identifier.uri | http://ugspace.ug.edu.gh/handle/123456789/26331 | |
dc.language.iso | en | en_US |
dc.publisher | Journal of Infectious Diseases | en_US |
dc.subject | attenuated | en_US |
dc.subject | diarrhea | en_US |
dc.subject | gastroenteritis | en_US |
dc.subject | Ghana | en_US |
dc.subject | humans | en_US |
dc.subject | infant | en_US |
dc.subject | infantile | en_US |
dc.subject | randomized controlled trial | en_US |
dc.subject | rotavirus | en_US |
dc.subject | rotavirus infections | en_US |
dc.subject | rotavirus vaccines | en_US |
dc.subject | vaccines | en_US |
dc.title | Efficacy, immunogenicity, and safety of two doses of a tetravalent rotavirus vaccine RRV-TV in Ghana with the first dose administered during the neonatal period | en_US |
dc.type | Article | en_US |
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