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Research

Effectiveness of monovalent rotavirus vaccine in Bolivia: case-control study

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f3726 (Published 19 June 2013) Cite this as: BMJ 2013;346:f3726
  1. Manish M Patel, epidemiologist1,
  2. Maritza Patzi, epidemiologist2,
  3. Desiree Pastor, epidemiologist3,
  4. Aleida Nina, microbiologist4,
  5. Yelin Roca, microbiologist5,
  6. Leovigildo Alvarez, microbiologist6,
  7. Volga Iniguez, research microbiologist7,
  8. Rosario Rivera, microbiologist7,
  9. Ka Ian Tam, microbiologist1,
  10. Osbourne Quaye, microbiologist1,
  11. Michael Bowen, research microbiologist1,
  12. Umesh Parashar, epidemiologist1,
  13. Lucia Helena De Oliveira, epidemiologist8
  1. 1Viral Gastroenteritis Team, DVD, NCIRD, MS-A34, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333, USA
  2. 2Ministerio de Salud, La Paz, Bolivia
  3. 3PanAmerican Health Organization, La Paz, Bolivia
  4. 4Laboratorio de Virologia, INLASA, Ministerio de Salud y Deportes, La Paz, Bolivia
  5. 5National Reference Laboratory, CENETROP, Santa Cruz, Bolivia
  6. 6Laboratorio de Virologia, Cochababma, Bolivia
  7. 7Instituto de Biologia Molecular y Biotecnologia, Universidad Mayor de San Andres, La Paz, Bolivia
  8. 8PanAmerican Health Organization, Washington DC, USA
  1. Correspondence to: M Patel Aul3{at}CDC.GOV
  • Accepted 28 May 2013

Abstract

Objective To evaluate the effectiveness of two doses of a monovalent rotavirus vaccine (RV1) against hospital admission for rotavirus in Bolivia.

Design Case-control study.

Setting Six hospitals in Bolivia, between March 2010 and June 2011.

Participants 400 hospital admissions for rotavirus, 1200 non-diarrhea hospital controls, and 718 rotavirus negative hospital controls.

Main outcome measures Odds of antecedent vaccination between case patients and controls; effectiveness of vaccination ((1–adjusted odds ratio)×100), adjusted for age and other confounders; and stratified effectiveness by dose, disease severity, age group, and serotype.

Results In comparison with non-diarrhea controls, case patients were more likely to be male and attend day care but less likely to have chronic underlying illness, higher level maternal education, and telephones and computers in their home. Rotavirus negative controls were somewhat more similar to case patients but also were more likely to be male and attend day care and less likely to have higher level maternal education and computers in their homes. The adjusted effectiveness of RV1 against hospital admission for rotavirus was 69% (95% confidence interval 54% to 79%) with rotavirus negative controls and 77% (65% to 84%) with non-diarrhea controls. The effectiveness of one dose of RV1 was 36% and 56%, respectively. With both control groups, protection was sustained through two years of life, with similar efficacy against hospital admission among children under 1 year (64% and 77%) and over 1 year of age (72% and 76%). RV1 provided significant protection against diverse serotypes, partially and fully heterotypic to the G1P[8] vaccine. Effectiveness using the two control groups was 80% and 85% against G9P[8], 74% and 93%% against G3P[8], 59% and 69% against G2P[4], and 80% and 87% against G9P[6] strains.

Conclusion The monovalent rotavirus vaccine conferred high protection against hospital admission for diarrhea due to rotavirus in Bolivian children. Protection was sustained through two years of life against diverse serotypes different from the vaccine strain.

Footnotes

  • We thank the sentinel hospital rotavirus surveillance team in Bolivia for their efforts in the enrollment of the participants for the rotavirus vaccine effectiveness evaluation.

  • Contributors: MMP, UP, DP, VI, and LHDO created and designed the study. DP, MP, AN, RR, and YR collected the data. AN, YR, VI, RR, KIT, OQ, and MP did the specimen analysis. MMP did the data analysis. MP, DP, VI, MB, UP, and LHDO interpreted the data. MMP drafted the report. DP, MP, AN, YR, VI, RR, KIT, OQ, MB, UP, and LHDO critically revised the report.

  • Funding: Support for this project was provided by the Program for Appropriate Technology in Health (PATH) through funding from the Global Alliance for Vaccines and Immunisation (GAVI). The views expressed by the authors do not necessarily reflect the views of GAVI or PATH. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: support for this project was provided by PATH through funding from GAVI; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This case-control evaluation was approved by human subjects’ offices at the Centers for Disease Control and Prevention, the Pan American Health Organization, and the Bolivian National Bioethics Committee. Surveillance coordinators obtained informed consent from parents or legal guardian of the child.

  • Data sharing: No additional data available.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

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