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.authorArmah, G.E.
dc.contributor.authorKapikian, A.Z.
dc.contributor.authorVesikari, T.
dc.contributor.authorCunliffe, N.
dc.contributor.authorJacobson, R.M.
dc.contributor.authorBurlington, D.B.
dc.contributor.authorRuiz, Jr. L.P.
dc.date.accessioned2018-12-11T15:02:39Z
dc.date.available2018-12-11T15:02:39Z
dc.date.issued2013-08
dc.description.abstractBackground. Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age.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.otherhttps://doi.org/10.1093/infdis/jit174
dc.identifier.otherVol. 208(3): pp 423-431
dc.identifier.urihttp://ugspace.ug.edu.gh/handle/123456789/26331
dc.language.isoenen_US
dc.publisherJournal of Infectious Diseasesen_US
dc.subjectattenuateden_US
dc.subjectdiarrheaen_US
dc.subjectgastroenteritisen_US
dc.subjectGhanaen_US
dc.subjecthumansen_US
dc.subjectinfanten_US
dc.subjectinfantileen_US
dc.subjectrandomized controlled trialen_US
dc.subjectrotavirusen_US
dc.subjectrotavirus infectionsen_US
dc.subjectrotavirus vaccinesen_US
dc.subjectvaccinesen_US
dc.titleEfficacy, immunogenicity, and safety of two doses of a tetravalent rotavirus vaccine RRV-TV in Ghana with the first dose administered during the neonatal perioden_US
dc.typeArticleen_US

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