Effectiveness of Monovalent and Pentavalent Rotavirus Vaccines in Guatemala

Clinical Infectious Diseases, Apr 2016

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.

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Effectiveness of Monovalent and Pentavalent Rotavirus Vaccines in Guatemala

CID Effectiveness of Monovalent and Pentavalent Rotavirus Vaccines in Guatemala Paul A. Gastañaduy 1 2 3 Ingrid Contreras-Roldán 0 2 Chris Bernart 0 2 Beatriz López 0 2 Stephen R. Benoit 2 5 Marvin Xuya 0 2 Fredy Muñoz 0 2 Rishi Desai 1 2 3 Osbourne Quaye 1 2 4 Ka Ian Tam 1 2 Diana K. Evans-Bowen 1 2 Umesh D. Parashar 2 3 Manish Patel 2 3 John P. McCracken 0 2 0 Center for Health Studies, Universidad del Valle de Guatemala 1 National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia 2 tion and Respiratory Diseases, Centers for Disease Control and Prevention , 1600 Clifton Rd NE, MS A-34, Atlanta, GA 30333 3 Epidemic Intelligence Service 4 West African Center for Cell Biology of Infectious Pathogens, Department of Biochemistry, Cell and Molecular Biology, University of Ghana , Legon 5 International Emerging Infections Program, Centers for Disease Control and Prevention , Guatemala City 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. - To help control the large burden of childhood deaths and hospitalizations associated with rotavirus disease, the World Health Organization (WHO) recommends all infants receive 1 of 2 live oral rotavirus vaccines, a monovalent human vaccine (Rotarix [RV1], GlaxoSmithKline Biologicals, Rixensart, Belgium), or a pentavalent bovine-derived vaccine (RotaTeq [RV5], Merck and Co, Whitehouse Station, New Jersey) [ 1 ]. Although both vaccines were found to perform well in prelicensure studies in middle- and high-income countries, where efficacy ranged from 77% to 98% [ 2–4 ], the efficacy of these vaccines was lower (18%–64%) in low-income settings of Africa and Asia [ 5–7 ]. The lower efficacy in low-income populations may be related to host and environmental factors (eg, enteric coinfections, concurrent oral polio vaccine administration, micronutrient malnutrition, transplacental maternal antibodies, and human immunodeficiency virus infection) that could impede initial immune responses and adversely affect vaccine performance [ 8, 9 ]. Accordingly, evaluating vaccine effectiveness (VE) under routine conditions in resource-limited settings remains a public health priority. Although >25 middle- and high-income countries have adopted rotavirus vaccines for routine childhood immunization, and several of these countries have documented large declines in rotavirus disease burden, fewer low-income countries are currently using rotavirus vaccines [ 10 ]. As a result, there are limited data on the field performance of these vaccines in developing countries, and WHO has emphasized the need for additional VE data from these settings [ 1 ]. In addition, previous field assessments in low-income settings in Latin America [ 11, 12 ], as well as recent clinical trials in Africa and Asia [ 5, 7 ], have shown a decline in protection in children aged >1 year, suggesting waning immunity in resource-limited settings. Moreover, given the differences in strain makeup between RV1 and RV5, and the constant evolution of new strains in resource-poor settings [ 13, 14 ], measuring RV1 and RV5 effectiveness during contemporaneous use in the same population is important. In parti (...truncated)


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Paul A. Gastañaduy, Ingrid Contreras-Roldán, Chris Bernart, Beatriz López, Stephen R. Benoit, Marvin Xuya, Fredy Muñoz, Rishi Desai, Osbourne Quaye, Ka Ian Tam, Diana K. Evans-Bowen, Umesh D. Parashar, Manish Patel, John P. McCracken. Effectiveness of Monovalent and Pentavalent Rotavirus Vaccines in Guatemala, Clinical Infectious Diseases, 2016, pp. S121-S126, 62/suppl 2, DOI: 10.1093/cid/civ1208