Efficacy of the human rotavirus vaccine RIX4414 in malnourished children.
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.


BACKGROUND
e-Track 444563-006, NCT00385320 (http://www.clinicaltrials.gov).
Perez-Schael
Irene
I
Instituto de Biomedicina-Fuvesin, Universidad Central de Venezuela, Ministerio de Salud, Caracas, Venezuela. ireneperezschael@cantv.net
Salinas
Belen
B
Tomat
Maria
M
Linhares
Alexandre C
AC
Guerrero
M Lourdes
ML
Ruiz-Palacios
Guillermo M
GM
Bouckenooghe
Alain
A
Yarzabal
Juan Pablo
JP
D000284:Administration, Oral; D001938:Brazil; D016001:Confidence Intervals; D003968:Diarrhea, Infantile / Q000150:complications / Q000517:prevention & control; D004306:Dose-Response Relationship, Immunologic; D005759:Gastroenteritis / Q000150:complications / Q000517:prevention & control; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D044342:Malnutrition / Q000150:complications*; D008800:Mexico; D012401:Rotavirus / Q000276:immunology*; D012400:Rotavirus Infections / Q000150:complications* / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage*; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000008:administration & dosage*; D014687:Venezuela
C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated