advanced search

<< Back To Home

WHAT'S NEW THIS SUNDAY ON WWW.CHILDSURVIVAL.NET: EFFICACY, IMMUNOGENICITY, AND SAFETY OF TWO DOSES OF A TETRAVALENT ROTAVIRUS VACCINE RRV-TV IN GHANA

Friday, 26th of April 2013

.

•   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

1. George E. Armah1, Albert Z. Kapikian2, Timo Vesikari3, Nigel Cunliffe4, Robert M. Jacobson5, D. Bruce Burlington6 and Leonard P. Ruiz Jr7

+ Author Affiliations

1. ¹College of Health Sciences, University of Ghana, Legon, Ghana
2. ²Epidemiology Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
3. ³Vaccine Research Center, University of Tampere , Finland
4. ⁴Department of Clinical Infection, Microbiology and Immunology, University of Liverpool, Liverpool, United Kingdom
5. ⁵Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, Minnesota
6. ⁶Gaithersburg, Maryland
7. ⁷International Medica Foundation, Rochester, Minnesota

1. Correspondence: Robert M. Jacobson, M.D. Mayo Clinic—Desk Ba3b, 200 First St SW, Rochester, MN 55905-0001, Tel: 507-538-1642, Fax: 507-284-9744, Email: jacobson.robert@mayo.edu

Abstract below; full text available to JID subscribers

Background. Oral rhesus/rhesus-human reassortant rotavirus tetravalent (RRV-TV) vaccine was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age.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 of two 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 two 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 four serotypes represented in the vaccine and 60.7% against RV-GE associated with any rotavirus serotype.

Conclusions. RRV-TV in a two-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 two most widely marketed, licensed, live virus, oral rotavirus vaccines.