Efficacy of the human rotavirus vaccine RIX4414 in malnourished children.

Author(s): Perez-Schael I, Salinas B, Tomat M, Linhares AC, Guerrero ML, Ruiz-Palacios GM, Bouckenooghe A, Yarzabal JP

Affiliation(s): Instituto de Biomedicina-Fuvesin, Universidad Central de Venezuela, Ministerio de Salud, Caracas, Venezuela. ireneperezschael@cantv.net

Publication date & source: 2007-08-15, J Infect Dis., 196(4):537-40. Epub 2007 Jun 29.

Publication type: Clinical Trial; Clinical Trial, Phase II; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

The effect of nutritional status on protective efficacy of a live attenuated human rotavirus vaccine (RIX4414) was studied. Vaccine protection was evaluated through a secondary analysis of data from an efficacy study conducted in Brazil, Mexico, and Venezuela. Vaccine efficacy against rotavirus gastroenteritis (RVGE) was similar in well-nourished and malnourished infants: 74.1% (95% confidence interval [CI], 52.2%-86.2%) and 73% (95% CI, 11.2%-92.3%) for severe RVGE and 60.9% (95% CI, 37.4%-75.4%) and 61.2% (95% CI, 10.4%-83.1%) for RVGE of any severity, respectively. RIX4414 significantly decreased the rate of RVGE regardless of nutritional status, which suggests that this patient group can also benefit from rotavirus vaccination. CLINICAL TRIALS REGISTRY: e-Track 444563-006, NCT00385320 (http://www.clinicaltrials.gov).