Ethical rationale for the ebola "ring vaccination" trial design

American Journal of Public Health

Volumn 106, Issue 3, 2016, Pages 432-435

  Rid, Annette ^a   Miller, Franklin G ^b  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EBOLA VACCINE;

CLINICAL TRIAL (TOPIC); CONTACT EXAMINATION; ETHICS; HUMAN; METHODOLOGY; PROCEDURES;

CLINICAL TRIALS AS TOPIC; CONTACT TRACING; EBOLA VACCINES; HUMANS; RESEARCH DESIGN;

EID: 84959042223     PISSN: 00900036     EISSN: 15410048     Source Type: Journal    
DOI: 10.2105/AJPH.2015.302996     Document Type: Article

References (26)

1. Ebolaça Suffit Ring Vaccination Trial Consortium. The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola. BMJ. 2015;351: h3740.
2. Henao-Restrepo AM, Longini IM, Egger M, et al. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial. Lancet. 2015;386 (9996):857-866.
3. Kanapathipillai R, Henao Restrepo AM, Fast P, et al. Ebola vaccine-an ur gent international priority. N Engl J Med. 2014;371(24):2249-2251.
4. An Ebola vaccine: first results and promising opportunities. Lancet. 2015;386 (9996):830.
5. Fenner F, Henderson DA, Arita I, et al. Smallpox and Its Eradication. Geneva, Switzerland: World Health Organization; 1988.
6. Agnandji ST, Huttner A, Zinser ME, et al. Phase 1 trials of rVSV Ebola vaccine in Africa and Europe-preliminary report. N Engl J Med. 2015;Epub ahead of print.
7. Regules JA, Beigel JH, Paolino KM, et al. A recombinant vesicular stomatitis virus Ebola vaccine-preliminary report. N Engl J Med. 2015;Epub ahead of print.
8. Krause PR. Interim results from a phase 3 Ebola vaccine study in Guinea. Lancet 2015;386(9996):831-833.
9. World Health Organization. Ebola data and statistics: Guinea. Available at: http:// apps.who.int/gho/data/node.ebola-sitrep.ebola-country-GIN?lang=en. Accessed November 15, 2015.
10. Protocole d'étude: Essai de vaccination visant à évaluer l'efficacité et l'innocuité du vaccin contre le virus Ebola en Guinée, Afrique de l'Ouest. Available at: http://www.bmj.com/content/bmj/ suppl/2015/07/27/bmj.h3740.DC1/ cama026973.w1-default.pdf Accessed November 15, 2015.
11. Wellcome Trust and Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. Recommendations for Accelerating the Development of Ebola Vaccines: Report & Analysis. February 2015. Available at: http://www.cidrap.umn.edu/sites/ default/ files/public/downloads/ ebola-viru s-team-b-report- final-021615.pdf Accessed November 15,2015.
12. Philipp A, Larimer S, Achenbach J. Ebola vaccine appears to be highly effective, could be 'a game-changer.' Washington Post. July 31, 2015. Available at: http://www.washingtonpost.com/ news/to-your-health/wp/2015/07/31/ ebola-vaccine-appears-to-be-highly-effective-could-be-a-game-changer. Accessed November 15, 2015.
13. World Health Organization. Questions and Answers - Ebola ça suffit! - phase III vaccine trial in Guinea. July 31, 2015. Available at: http://www.who.int/ medicines/ebola-treatment/ q-a-phase3vaxtrial-guinea/en. Accessed November 15, 2015.
14. Farrar J. The Ebola vaccine we dared to dream of is here. Guardian. August 3, 2015. Available at: http://www. theguardian.com/commentisfree/2015/ aug/03/ebola-vaccine-trials-diseases? CMP=share-btn-link. Accessed November 15, 2015.
15. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283:2701-2711.
16. Lipsitch M, Eyal N, Halloran ME, et al. Vaccine testing: Ebola and beyond. Science. 2015;348:46-48.
17. Levine RJ. Ethics and Regulation of Clinical Research. 2nd ed. New Haven, CT: Yale University Press; 1986:202-207.
18. Hay M, Thomas DW, Craighead JL, et al. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32:40-51.
19. Røttingen JA. Ebola vaccine trial in Guinea. Lancet. 2015;385(9986): 2459-2460.
20. Shuchman M. Ebola vaccine trial in west Africa faces criticism. Lancet. 2015; 385(9981):1933-1934.
21. Joffe S, Miller FG. Bench to bedside: mapping the moral terrain of clinical research. Hastings Cent Rep. 2008;38(2):30-42.
22. Rid A, Wendler D. A framework for risk-benefit evaluations in biomedical research. Kennedy Inst Ethics J. 2011;21: 141-179.
23. Geisbert TW, Geisbert JB, Leung A, et al. Single-injection vaccine protects nonhuman primates against infection with Marburg virus and three species of Ebola virus. J Virol. 2009;83:7296-7304.
24. Berkley S. Ebola vaccine: the need to act now. New York Times. August 2, 2015. Available at: http://www.nytimes.com/ 2015/08/03/opinion/ebola-vaccine-the-need-to-act-now.html? emc=eta1&-r=0. Accessed November 15, 2015.
25. Haire BG, Folayan MO. Ebola: what it teaches us about medical ethics. A response to Angus Dawson. J Med Ethics. 2016;42(1):59-60.
26. Miller FG, Rosenstein DL. The therapeutic orientation to clinical trials. N Engl J Med. 2003;348:1383-1386.