A short report on highlights of world-wide development of RIX4414: A Latin American experience

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, Mexic...

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Bibliographic Details
Published in:	Vaccine Vol. 24; no. 18; pp. 3784 - 3785
Main Authors:	Linhares, A.C., 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., Vos, B. De
Format:	Journal Article Conference Proceeding
Language:	English
Published:	Oxford Elsevier Ltd 01-05-2006 Elsevier Elsevier Limited
Subjects:	Administration, Oral Applied microbiology Biological and medical sciences Brazil Children & youth Diarrhea Double-Blind Method Efficacy Fundamental and applied biological sciences. Psychology Gastroenteritis Gastroenteritis - epidemiology Gastroenteritis - prevention & control Hospitalization Hospitalization - statistics & numerical data Humans Immunogenicity Incidence Infant Infants Latin America Mexico Microbiology Miscellaneous Rotavirus Rotavirus Infections - epidemiology Rotavirus Infections - prevention & control Rotavirus Vaccines - administration & dosage Rotavirus Vaccines - adverse effects Rotavirus Vaccines - immunology Studies Vaccine Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Attenuated - administration & dosage Vaccines, Attenuated - adverse effects Vaccines, Attenuated - immunology Venezuela Virology Viruses World America Latin America Brazil Venezuela Mexico Efficacy Vaccine Rotavirus Latin America Virus American Efficiency Reoviridae
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Article-2 ObjectType-Feature-1 ObjectType-News-3
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2005.07.027