Effectiveness of Monovalent and Pentavalent Rotavirus Vaccines in Guatemala

Clin Infect Dis. 2016 May 1:62 Suppl 2:S121-6. doi: 10.1093/cid/civ1208.

Abstract

Background: Concerns remain about lower effectiveness and waning immunity of rotavirus vaccines in resource-poor populations. We assessed vaccine effectiveness against rotavirus in Guatemala, where both the monovalent (RV1; 2-dose series) and pentavalent (RV5; 3-dose series) vaccines were introduced in 2010.

Methods: A case-control evaluation was conducted in 4 hospitals from January 2012 to August 2013. Vaccine status was compared between case patients (children with laboratory-confirmed rotavirus diarrhea) and 2 sets of controls: nondiarrhea "hospital" controls (matched by birth date and site) and nonrotavirus "test-negative" diarrhea controls (adjusted for age, birth month/year, and site). Vaccine effectiveness ([1 - odds ratio of vaccination] × 100%) was computed using logistic regression models.

Results: We evaluated 213 case patients, 657 hospital controls, and 334 test-negative controls. Effectiveness of 2-3 doses of a rotavirus vaccine against rotavirus requiring emergency department visit or hospitalization was 74% (95% confidence interval [CI], 58%-84%) with hospital controls, and 52% (95% CI, 26%-69%) with test-negative controls. Using hospital controls, no significant difference in effectiveness was observed between infants 6-11 months (74% [95% CI, 18%-92%]) and children ≥12 months of age (71% [95% CI, 44%-85%]) (P= .85), nor between complete courses of RV1 (63% [95% CI, 23%-82%]) and RV5 (69% [95% CI, 29%-87%]) (P= .96). An uncommon G12P[8] strain, partially heterotypic to strains in both vaccines, was identified in 89% of cases.

Conclusions: RV1 and RV5 were similarly effective against severe rotavirus diarrhea caused by a heterotypic strain in Guatemala. This supports broader implementation of rotavirus vaccination in low-income countries where >90% global deaths from rotavirus occur.

Keywords: Guatemala; gastroenteritis; rotavirus; vaccine effectiveness.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Case-Control Studies
  • Child, Preschool
  • Diarrhea / epidemiology
  • Diarrhea / virology
  • Emergency Service, Hospital
  • Female
  • Guatemala / epidemiology
  • Hospitalization
  • Humans
  • Infant
  • Logistic Models
  • Male
  • Odds Ratio
  • Poverty
  • Rotavirus / immunology
  • Rotavirus / isolation & purification
  • Rotavirus Infections / diagnosis
  • Rotavirus Infections / epidemiology
  • Rotavirus Infections / prevention & control*
  • Rotavirus Infections / virology
  • Rotavirus Vaccines / administration & dosage
  • Rotavirus Vaccines / immunology*
  • Vaccination
  • Vaccine Potency
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / immunology

Substances

  • RIX4414 vaccine
  • RotaTeq
  • Rotavirus Vaccines
  • Vaccines, Attenuated