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. 2015 Dec 15;61(12):1792-9.
doi: 10.1093/cid/civ872. Epub 2015 Oct 8.

Long-term Consistency in Rotavirus Vaccine Protection: RV5 and RV1 Vaccine Effectiveness in US Children, 2012-2013

Daniel C Payne  1 , Rangaraj Selvarangan  2 , Parvin H Azimi  3 , Julie A Boom  4 , Janet A Englund  5 , Mary Allen Staat  6 , Natasha B Halasa  7 , Geoffrey A Weinberg  8 , Peter G Szilagyi  9 , James Chappell  7 , Monica McNeal  6 , Eileen J Klein  5 , Leila C Sahni  10 , Samantha H Johnston  3 , Christopher J Harrison  2 , Carol J Baker  11 , David I Bernstein  6 , Mary E Moffatt  2 , Jacqueline E Tate  1 , Slavica Mijatovic-Rustempasic  1 , Mathew D Esona  1 , Mary E Wikswo  1 , Aaron T Curns  1 , Iddrisu Sulemana  1 , Michael D Bowen  1 , Jon R Gentsch  1 , Umesh D Parashar  1
Affiliations

Long-term Consistency in Rotavirus Vaccine Protection: RV5 and RV1 Vaccine Effectiveness in US Children, 2012-2013

Daniel C Payne et al. Clin Infect Dis. .

Abstract

Background: Using a multicenter, active surveillance network from 2 rotavirus seasons (2012 and 2013), we assessed the vaccine effectiveness of RV5 (RotaTeq) and RV1 (Rotarix) rotavirus vaccines in preventing rotavirus gastroenteritis hospitalizations and emergency department (ED) visits for numerous demographic and secular strata.

Methods: We enrolled children hospitalized or visiting the ED with acute gastroenteritis (AGE) for the 2012 and 2013 seasons at 7 medical institutions. Stool specimens were tested for rotavirus by enzyme immunoassay and genotyped, and rotavirus vaccination histories were compared for rotavirus-positive cases and rotavirus-negative AGE controls. We calculated the vaccine effectiveness (VE) for preventing rotavirus associated hospitalizations and ED visits for each vaccine, stratified by vaccine dose, season, clinical setting, age, predominant genotype, and ethnicity.

Results: RV5-specific VE analyses included 2961 subjects, 402 rotavirus cases (14%) and 2559 rotavirus-negative AGE controls. RV1-specific VE analyses included 904 subjects, 100 rotavirus cases (11%), and 804 rotavirus-negative AGE controls. Over the 2 rotavirus seasons, the VE for a complete 3-dose vaccination with RV5 was 80% (confidence interval [CI], 74%-84%), and VE for a complete 2-dose vaccination with RV1 was 80% (CI, 68%-88%).Statistically significant VE was observed for each year of life for which sufficient data allowed analysis (7 years for RV5 and 3 years for RV1). Both vaccines provided statistically significant genotype-specific protection against predominant circulating rotavirus strains.

Conclusions: In this large, geographically and demographically diverse sample of US children, we observed that RV5 and RV1 rotavirus vaccines each provided a lasting and broadly heterologous protection against rotavirus gastroenteritis.

Keywords: RV1-Rotarix; RV5-RotaTeq; acute gastroenteritis; rotavirus vaccine; surveillance.

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Conflict of interest statement

All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Potential conflicts of interest. M. A. S. received past research funding from Merck Research Laboratories, Inc., and current funding from GlaxoSmithKline, Inc., and served on the Rotavirus Advisory Board for Merck and Co. and for GlaxoSmithKline, Inc. D. I. B. received research funding from GlaxoSmithKline; Merck & Co., Inc., and Wyeth Laboratories; Patent on GlaxoSmithKline Rotavirus Vaccine (RV1).

Figures

Figure 1
Figure 1
RV5 and RV1 Analysis Subject Inclusion Flowchart. Abbreviations: AGE, acute gastroenteritis; ED, emergency department.
Figure 2
Figure 2
RV5 and RV1 vaccine effectiveness by predominant rotavirus strain, 2012–13 (hospitalizations and emergency department visits).
Figure 3
Figure 3
RV5 vaccine effectiveness 2007–2013. Amalgamated results from active surveillance studies using a similar research protocol for evaluating vaccine effectiveness. Notes: (2008) Boom JA, et al Pediatrics 2010. (2009) Boom JA, et al Pediatr Infect Dis J 2010. (2007–09) Staat MA, et al Pediatrics 2011. (2010) Payne DC, et al (1) Clin Infect Dis 2013. (2011) Payne DC, et al (1) Clin Infect Dis 2013. (2012) Payne DC, et al (2) Clin Infect Dis 2015. (2013) Payne DC, et al (2) Clin Infect Dis 2015.
See this image and copyright information in PMC

References

    1. Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354:11–22. - PubMed
    1. Linhares AC, Velázquez FR, Pérez-Schael I, et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastro-enteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet. 2008;371:1181–9. - PubMed
    1. Vesikari T, Karvonen A, Puustinen L, et al. Efficacy of RIX 4414 live attenuated human rotavirus vaccine in Finnish infants. Pediatr Infect Dis J. 2004;23:937–43. - PubMed
    1. Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomized, double-blind controlled study. Lancet. 2007;370:1757–63. - PubMed
    1. Centers for Disease Control and Prevention. Prevention of rotavirus gastroenteritis among infants and children: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR. 2009;58:1–26. - PubMed

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