title: A short report on highlights of world-wide development of RIX4414: a Latin American experience.
abstract: 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.
authors.affiliation: Instituto Evandro Chagas, Secretaria de Vigilância em Saúde, MS, Av. Almirante Barroso, 492, Marco CEP 66.090-000, Belém, Pará, Brazil. alexandrelinhares@iec.pa.gov.br
authors.forename: A C
authors.initials: AC
authors.lastname: Linhares
authors.forename: G M
authors.initials: GM
authors.lastname: Ruiz-Palacios
authors.forename: M L
authors.initials: ML
authors.lastname: Guerrero
authors.forename: B
authors.initials: B
authors.lastname: Salinas
authors.forename: I
authors.initials: I
authors.lastname: Perez-Schael
authors.forename: S A Costa
authors.initials: SA
authors.lastname: Clemens
authors.forename: B
authors.initials: B
authors.lastname: Innis
authors.forename: J P
authors.initials: JP
authors.lastname: Yarzabal
authors.forename: G
authors.initials: G
authors.lastname: Vespa
authors.forename: Y
authors.initials: Y
authors.lastname: Cervantes
authors.forename: K
authors.initials: K
authors.lastname: Hardt
authors.forename: B
authors.initials: B
authors.lastname: De Vos
mesh_terms: D000284:Administration, Oral; D001938:Brazil; D004311:Double-Blind Method; D005759:Gastroenteritis / Q000453:epidemiology / Q000517:prevention & control*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D015994:Incidence; D007223:Infant; D008800:Mexico; D012400:Rotavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014687:Venezuela
chemical_list: C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated