A short report on highlights of world-wide development of RIX4414: a latin american experience

• Autor(a) principal: Linhares, Alexandre da Costa
• Data de Publicação: 2006
• Outros Autores: Ruiz-Palacios, G. M, Guerrero, M. L, Salinas, B, Perez-Schael, I, Clemens, S. A. Costa, Innis, B, Yarzabal, J. P, Vespa, G, Cervantes, Y, Hardt, K, De Vos, B
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Digital do Instituto Evandro Chagas (Patuá)
• DOI: 10.1016/j.vaccine.2005.07.027
• Texto Completo: https://patua.iec.gov.br/handle/iec/1073
• topic: Rotavirus; Vacinas contra Rotavirus / análise; Vacinas contra Rotavirus / uso terapêutico; América Latina

An oral, human-derived monovalent (G1P1A) rotavirus vaccine, strain RIX4414, has been developed by GlaxoSmithKline, Rixensart, Belgium. The safety, immunogenicity and efficacy of this vaccine were evaluated in a randomized, double-blind, placebo-controlled, phase IIb trial conducted in Brazil, Mexico and Venezuela. Healthy infants were given two doses of vaccine (104.7, 105.2 or 105.8 ffu) or placebo at age 2 and 4 months, with routine DTPw-HBV and Hib vaccines. OPV was given separately, at least 2 weeks before or after administration of the study vaccine. A total of 2155 infants were enrolled, of whom 1618 received one of the three vaccine viral concentrations and 537 were given placebo. Analysis of efficacy included diarrheal episodes occurring from 2 weeks after second dose until one year of age. Efficacy rates against any rotavirus gastroenteritis, severe rotavirus gastroenteritis and hospitalizations for rotavirus disease were as high as 70% (46–84%; 95%CI), 86% (63–96%; 95%CI), and 93% (54–100%; 95%CI), respectively. For non-G1 (mainly G9) serotypes, RIX4414 vaccine conferred protection as high as 83% (40–97%; 95%CI) against severe gastroenteritis. A decrease was noted in the incidence of severe rotavirus-related gastroenteritis after first dose. It is demonstrated that two doses of RIX4414 are highly efficacious against severe rotavirus gastroenteritis and hospitalization, including disease caused by non-G1 strains, namely G9 serotypes.