Published online July 2, 2007
PEDIATRICS Vol. 120 No. 2 August 2007, pp. e253-e261 (doi:10.1542/peds.2006-2630)
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ARTICLE

Dose Response and Efficacy of a Live, Attenuated Human Rotavirus Vaccine in Mexican Infants

Guillermo M. Ruiz-Palacios, MDa, M. Lourdes Guerrero, MDa, Aurora Bautista-Márquez, MDa, Hilda Ortega-Gallegos, BAa, Fernando Tuz-Dzib, BSa, Leticia Reyes-González, BSa, Gustavo Rosales-Pedraza, BSa, Julia Martínez-López, BSa, Erika Castañón-Acosta, BSa, Yolanda Cervantes, MDb, SueAnn Costa-Clemens, MDc and Beatrice DeVos, MDd

a Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
b GlaxoSmithKline Mexico, Mexico City, Mexico
c GlaxoSmithKline Latin America and Caribbean, Rio de Janeiro, Brazil
d GlaxoSmithKline Biologicals, Rixensart, Belgium

OBJECTIVE. Immunization against rotavirus has been proposed as the most cost-effective intervention to reduce the disease burden associated with this infection worldwide. The objective of this study was to determine the dose response, immunogenicity, and efficacy of 2 doses of an oral, attenuated monovalent G1[P8] human rotavirus vaccine in children from the same setting in Mexico, where the natural protection against rotavirus infection was studied.

METHODS. From June 2001 through May 2003, 405 healthy infants were randomly assigned to 1 of 3 vaccine groups (virus concentrations 104.7, 105.2, and 105.8 infectious units) and to a placebo group and were monitored to the age of 2 years. The vaccine/placebo was administered concurrently with diphtheria-tetanus toxoid-pertussis/hepatitis B/Haemophilus influenzae type b vaccine at 2 and 4 months of age. After the administration of the first vaccine/placebo dose, weekly home visits to collect information regarding infant health were conducted. Stool samples were collected during each gastroenteritis episode and tested for rotavirus antigen and serotype.

RESULTS. The vaccine was well tolerated and induced a greater rate of seroconversion than observed in infants who received placebo. For the pooled vaccine groups, efficacy after 2 oral doses was 80% and 95% against any and severe rotavirus gastroenteritis, respectively. Efficacy was 100% against severe rotavirus gastroenteritis and 70% against severe gastroenteritis of any cause with the vaccine at the highest virus concentration (105.8 infectious units). The predominant infecting rotavirus serotype in this cohort was wild-type G1 (85%). Adverse events, including fever, irritability, loss of appetite, cough, diarrhea, and vomiting, were similar among vaccinees and placebo recipients.

CONCLUSION. This new oral, live, attenuated human rotavirus vaccine was safe, immunogenic, and highly efficacious in preventing any and, more importantly, severe rotavirus gastroenteritis in healthy infants. This vaccine produced comparable protection to natural infection.

Key Words: vaccines • rotavirus diarrhea • viral gastroenteritis • immunization

Abbreviations: HRV—human rotavirus vaccine • IU—infectious units • CI—confidence interval • IgA—immunoglobulin A • ELISA—enzyme-linked immunosorbent assay • ITT—intention-to-treat • ATP—according-to-protocol

Accepted Jan 26, 2007.