A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis

• Published in: The Pediatric infectious disease journal Vol. 23; no. 10 Suppl; p. S179
• Main Authors: De Vos, Beatrice, Vesikari, Timo, Linhares, Alexandre C, Salinas, Belén, Pérez-Schael, Irene, Ruiz-Palacios, Guillermo M, Guerrero, Maria de Lourdes, Phua, Kong Boo, Delem, Andrée, Hardt, Karin
• Format: Journal Article
• Language: English
• Published: United States 01.10.2004
• Subjects: Clinical Trials as Topic; Gastroenteritis - prevention & control; Gastroenteritis - virology; Humans; Infant; Rotavirus Infections - prevention & control; Rotavirus Vaccines - immunology
• ISSN: 0891-3668
• DOI: 10.1097/01.inf.0000142370.16514.4a

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.