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. Armah, G. E, Kapikian, A. Z, Vesikari, T., Cunliffe, N., Jacobson, R. M, Burlington, D B., & Ruiz, J. The Journal of infectious diseases, 208(3):423–431, August, 2013.
doi  abstract   bibtex   
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 Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age.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.
@article{armah_efficacy_2013,
	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}},
	volume = {208},
	issn = {1537-6613},
	doi = {10.1093/infdis/jit174},
	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 Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age.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.},
	language = {eng},
	number = {3},
	journal = {The Journal of infectious diseases},
	author = {Armah, George E and Kapikian, Albert Z and Vesikari, Timo and Cunliffe, Nigel and Jacobson, Robert M and Burlington, D Bruce and Ruiz, Jr, Leonard P},
	month = aug,
	year = {2013},
	pmid = {23599316},
	pages = {423--431},
}

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