The Efficacy and Safety of Rotavirus Vaccine in Children under the Five Years of Age; Systematic Review and Meta-Analysis

Document Type : Review Article

Authors

1 Assistant Professor, Department of Community Medicine, School of Medical Education, Shahid Beheshti University of Medical Sciences, Tehran, Iran

2 Associate Professor, Department of Community Medicine, School of Medicine AND Gastro-Intestinal and Liver Disease Research Center, Iran University of Medical Sciences, Tehran, Iran

3 Associate Professor, Department of Pediatrics, Akbarabadi Hospital, Iran University of Medical Sciences, Tehran, Iran

4 Health Technology Assessment Office, Department of Standardization and Tariff, Deputy of Curative Affairs, Ministry of Health and Medical Education, Tehran, Iran

5 Research Center for Modeling in Health, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran

6 Clinical Knowledge Management Unit, Department of Community Medicine, School of Medicine, Iran University of Medical Sciences, Tehran, Iran

Abstract

Background: Rotavirus infection is a common cause of acute gastroenteritis among uner-5-years-old children, especially in those countries which has not implemented a rotavirus vaccination program. The aim of this study was to estimate the safety and efficacy of Rotarix® and Rotateq® vaccines.Methods: We performed a systematic literature review in randomized controlled trials and quasi-experimental studies on children of general population. We searched Medline, Ovid, ISI, Cochrane, Proquest, Scopus, DARE, HTA and NHSEED databases. Meta-analysis was performed and we assessed heterogeneity using Q test and used random model for pooling estimate of efficacy of rotavirus vaccines (Rotarix® and Rotateq®). Publication bias was assessed via Egger’s and Begg’s tests.Findings: Twelve eligible studies were included in meta-analysis. The pooled estimate of vaccine efficacy for Rotarix® and Rotateq® was 80% (95% CI: 0.68-0.87) and 70% (95% CI: 0.65-0.85), respectively. Relative risk of side effects in vaccinated versus no-vaccinated groups was in the range of 0.83 to 1.2.Conclusion: The results show that vaccination against rotavirus prevented sever and none-severe diarrhea in children and could reduce burden of the disease. It is necessary to perform cost-effectiveness studies for implementing rotavirus vaccination in Iran.

Keywords

References

  1. Serotyping of group A rotaviruses in children less than 7 years old in Tehran. Pajouhesh Dar Pezeshki 2004; 28(3): 211-4. [In Persian].
  2. Rotavirus [Online]. [cited 2014 Jan]; Available from:http://sites.path.org/rotavirusvaccine/about-rotavirus/
  3. Khoury H, Ogilvie I, El Khoury AC, Duan Y, Goetghebeur MM. Burden of rotavirus gastroenteritis in the Middle Eastern and North African pediatric population. BMC Infect Dis 2011; 11: 9.
  4. Moradi Lakeh M, Shakerian S, Yaghoubi M, Esteghamati A, Shokraneh E, Baradaran HR, et al. Rotavirus infection in children with acute gastroenteritis in Iran, a systematic review and meta-analysis. Int J Prev Med 2014; 5(10): 1215-23.
  5. Centers for Disease Control and Prevention. Rotavirus [Online]. [cited 2013 Jun 20]; Available from: URL:http://www.cdc.gov/rotavirus/index.html?s_cid=cs_281
  6. World Health Organization. Rotavirus infections [Online]. [cited 2014 Jan]; Available from: URL:http://www.who.int/topics/rotavirus_infections/en/
  7. Parashar UD, Gibson CJ, Bresee JS, Glass RI. Rotavirus and severe childhood diarrhea. Emerg Infect Dis 2006; 12(2): 304-6.
  8. Malek MA, Teleb N, Abu-Elyazeed R, Riddle MS, Sherif ME, Steele AD, et al. The epidemiology of rotavirus diarrhea in countries in the Eastern Mediterranean Region. J Infect Dis 2010; 202)Suppl): S12-S22.
  9. Munos MK, Walker CL, Black RE. The effect of rotavirus vaccine on diarrhoea mortality. Int J Epidemiol 2010; 39(Suppl 1): i56-i62.
  10. Ruuska T, Vesikari T. Rotavirus disease in Finnish children: use of numerical scores for clinical severity of diarrhoeal episodes. Scand J Infect Dis 1990; 22(3): 259-67.
  11. Critical Appraisal Skills Programme (CASP) [Online]. [cited 2014 Jan]; Available from: URL: http://www.casp-uk.net/find-appraise-act/appraising-the-evidence/
  12. Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006; 354(1): 11-22.
  13. Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet 2010; 376(9741): 606-14.
  14. Phua KB, Lim FS, Lau YL, Nelson EA, Huang LM, Quak SH, et al. Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: randomised, double-blind, controlled study. Vaccine 2009; 27(43): 5936-41.
  15. Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, et al. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics 2007; 119(1): 11-8.
  16. Vesikari T, Itzler R, Matson DO, Santosham M, Christie CD, Coia M, et al. Efficacy of a pentavalent rotavirus vaccine in reducing rotavirus-associated health care utilization across three regions (11 countries). Int J Infect Dis 2007; 11(Suppl 2): S29-S35.
  17. Vesikari T, Matson DO, Dennehy P, Van DP, Santosham M, Rodriguez Z, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006; 354(1): 23-33.
  18. Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet 2010; 376(9741): 615-23.
  19. Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet 2007; 370(9601): 1757-63.
  20. Ruiz-Palacios GM, Guerrero ML, Bautista-Marquez A, Ortega-Gallegos H, Tuz-Dzib F, Reyes-Gonzalez L, et al. Dose response and efficacy of a live, attenuated human rotavirus vaccine in Mexican infants. Pediatrics 2007; 120(2): e253-e261.
  21. Araujo EC, Clemens SA, Oliveira CS, Justino MC, Rubio P, Gabbay YB, et al. Safety, immunogenicity, and protective efficacy of two doses of RIX4414 live attenuated human rotavirus vaccine in healthy infants. J Pediatr (Rio J) 2007; 83(3): 217-24.
  22. Vesikari T, Clark HF, Offit PA, Dallas MJ, DiStefano DJ, Goveia MG, et al. Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. Vaccine 2006; 24(22): 4821-9.
  23. Linhares AC, Velazquez FR, Perez-Schael I, Saez-Llorens X, Abate H, Espinoza F, et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet 2008; 371(9619): 1181-9.
  24. Chang CC, Chang MH, Lin TY, Lee HC, Hsieh WS, Lee PI. Experience of pentavalent human-bovine reassortant rotavirus vaccine among healthy infants in Taiwan. J Formos Med Assoc 2009; 108(4): 280-5.
  25. Dennehy PH, Goveia MG, Dallas MJ, Heaton PM. The integrated phase III safety profile of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine. Int J Infect Dis 2007; 11(Suppl 2): S36-S42.
  26. Breiman RF, Zaman K, Armah G, Sow SO, Anh DD, Victor JC, et al. Analyses of health outcomes from the 5 sites participating in the Africa and Asia clinical efficacy trials of the oral pentavalent rotavirus vaccine. Vaccine 2012; 30(Suppl 1): A24-A29.
  27. Enhance Reviews. Systematic review for the World Health Organization on Rotavirus vaccine schedules [Online]. [cited Jan 2014]; Available from: URL: http://enhance-reviews.com/systematic-review-for-the-world-health-organization-on-rotavirus-vaccine-schedules/
  28. Eesteghamati A, Gouya M, Keshtkar A, Najafi L, Zali MR, Sanaei M, et al. Sentinel hospital-based surveillance of rotavirus diarrhea in iran. J Infect Dis 2009; 200(Suppl 1): S244-S247.
  29. Rheingans RD, Antil L, Dreibelbis R, Podewils LJ, Bresee JS, Parashar UD. Economic costs of rotavirus gastroenteritis and cost-effectiveness of vaccination in developing countries. J Infect Dis 2009; 200(Suppl 1): S16-S27.
  30. Podewils LJ, Antil L, Hummelman E, Bresee J, Parashar UD, Rheingans R. Projected cost-effectiveness of rotavirus vaccination for children in Asia. J Infect Dis 2005; 192(Suppl 1): S133-S145.
  31. World Health Organization. Detailed review paper on rotavirus vaccines to be presented to the WHO Strategic Advisory Group of Experts (SAGE) on immunization, April 2009 [Online]. [cited 2009 Mar 17]; Available from: URL: http://www.who.int/immunization/sage/3_Detailed_Review_Paper_on_Rota_Vaccines_17_3_2009.pdf
  32. World Health Organization Global Advisory Committee on Vaccine Safety, 17-18 December 2008. Wkly Epidemiol Rec 2009; 84(5): 37-40.
Journal of Isfahan Medical School
Volume 32, Issue 303 - Serial Number 303
July and August 2014
Pages 1605-1622

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History

  • Receive Date: 08 February 2014
  • Revise Date: 30 April 2024
  • Accept Date: 06 April 2022

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