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

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.

• Authors: Miguel W Tregnaghi, 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
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 30 Issue 6 Pg. e103-8 (Jun 2011) ISSN: 1532-0987 [Electronic] United States
• PMID: 21378594 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Poliovirus Vaccine, Oral
• RIX4414 vaccine
• Rotavirus Vaccines
• Vaccines, Attenuated

Topics

• Double-Blind Method
• Female
• Gastroenteritis (prevention & control)
• Humans
• Immunization (adverse effects, methods)
• Immunization Schedule
• Infant
• Latin America
• Male
• Placebos (administration & dosage)
• Poliovirus Vaccine, Oral (administration & dosage)
• Rotavirus Infections (prevention & control)
• Rotavirus Vaccines (administration & dosage, adverse effects, immunology)
• Vaccines, Attenuated (administration & dosage, adverse effects, immunology)