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.
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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
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