Open AccessA Rotavirus Vaccine for Prophylaxis of Infants Against Rotavirus Gastroenteritis
Author(s) -
Béatrice De Vos,
Timo Vesikari,
Alexandre C. Linhares,
Beatriz Salinas,
Irene PérezSchael,
Guillermo RuizPalacios,
María de Lourdes Guerrero,
Kong Boo Phua,
A. Delem,
Karin Hardt
Publication year - 2004
Publication title -
the pediatric infectious disease journal/the pediatric infectious disease journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.028
H-Index - 140
eISSN - 1532-0987
pISSN - 0891-3668
DOI - 10.1097/01.inf.0000142370.16514.4a
Subject(s) - rotavirus , rotavirus vaccine , immunogenicity , medicine , rotavirus gastroenteritis , virology , pediatrics , placebo , vaccination , immunology , virus , antibody , alternative medicine , pathology
The need for safe and effective vaccines to reduce morbidity and mortality caused by rotavirus gastroenteritis in children is well-known. A live attenuated monovalent rotavirus vaccine (Rotarix) containing human rotavirus strain RIX4414 of G1P1A P[8] specificity is being developed to meet the global need. An overview of RIX4414 trials in developed and developing settings is presented for 3 selected trials conducted in Finland (pilot study), Latin America (Brazil, Mexico and Venezuela) and Singapore involving 5024 infants. The vaccine was well-tolerated, with no increase in any solicited symptoms as compared with the placebo. After 2 doses, 61-91% of vaccinated infants developed rotavirus-specific IgA antibodies. There was no interference with immunogenicity of coadministered routine pediatric vaccines. Rotarix significantly reduced rotavirus gastroenteritis episodes and rotavirus-related hospitalizations in vaccinated infants compared with placebo recipients (P < 0.05). Vaccine efficacy was observed against severe rotavirus gastroenteritis caused by G1 and non-G1 types including the emerging G9 type (P < 0.05) in Latin America. These results show prospects for widespread use of Rotarix to reduce rotavirus disease burden and warrant continued worldwide evaluation.