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Randomized Controlled Trial
. 2011 Jun;30(6):e103-8.
doi: 10.1097/INF.0b013e3182138278.

Human rotavirus vaccine is highly efficacious when coadministered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America

Miguel W Tregnaghi  1 , Héctor J Abate, Alejandra Valencia, Pio Lopez, Themis Reverbel Da Silveira, Luis Rivera, Doris Maribel Rivera Medina, Xavier Saez-Llorens, Silvia Elena Gonzalez Ayala, Tirza De León, Leen-Jan Van Doorn, Maria Del Pilar Rubio, Pemmaraju Venkata Suryakiran, Javier M Casellas, Eduardo Ortega-Barria, Igor V Smolenov, Htay-Htay Han; Rota-024 Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Human rotavirus vaccine is highly efficacious when coadministered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America

Miguel W Tregnaghi et al. Pediatr Infect Dis J. 2011 Jun.

Abstract

Background: The efficacy of a rotavirus vaccine against severe rotavirus gastroenteritis when coadministered with routine Expanded Program on Immunization (EPI) vaccines including oral polio vaccine (OPV) was evaluated in this study.

Methods: Double-blind, randomized (2:1), placebo-controlled study conducted across 6 Latin American countries. Healthy infants (N = 6568) 6 to 12 weeks of age received 2 doses of RIX4414 vaccine or placebo following a 0, 1- to 2-month schedule. Routine vaccines including OPV were coadministered according to local EPI schedule. Vaccine efficacy (VE) against severe rotavirus gastroenteritis caused by circulating wild-type rotavirus from 2 weeks post-Dose 2 until 1 year of age was calculated with 95% confidence interval [CI]. Safety was assessed during the entire study period. Immunogenicity of RIX4414 and OPV was also assessed.

Results: During the efficacy follow-up period (mean duration = 7.4 months), 7 and 19 cases of severe rotavirus gastroenteritis were reported in the vaccine and placebo groups, respectively, with a VE of 81.6% (95% CI: 54.4-93.5). VE against severe rotavirus gastroenteritis caused by G1 type was 100% (95% CI: <0-100) and 80.6% (95% CI: 51.4-93.2) against the pooled non-G1 rotavirus types, respectively. There was no difference (P = 0.514) in the incidence of serious adverse events reported in the 2 groups. Antirotavirus IgA seropositivity rate at 1 to 2 months post-Dose 2 was 61.4% (95% CI: 53.7-68.6) in the RIX4414 group; similar seroprotection rates (≥96.0%) against the 3 antipoliovirus types was observed 1 month post-Dose 3 of OPV in both groups.

Conclusion: RIX4414 was highly efficacious against severe rotavirus gastroenteritis caused by the circulating wild-type rotavirus (G1 and non-G1) when coadministered with routine EPI vaccines including OPV.

Trial registration: ClinicalTrials.gov NCT00139347.

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