Literature DB >> 26794172

Ethical Rationale for the Ebola "Ring Vaccination" Trial Design.

Annette Rid1, Franklin G Miller1.   

Abstract

The 2014 Ebola virus epidemic is the largest and most severe ever recorded. With no approved vaccines or specific treatments for Ebola, clinical trials were launched within months of the epidemic in an unprecedented show of global partnership. One of these trials used a highly innovative "ring vaccination" design. The design was chosen for operational, scientific, and ethical reasons--in particular, it was regarded as ethically superior to individually randomized placebo-controlled trials. We scrutinize the ethical rationale for the ring vaccination design. We argue that the ring vaccination design is ethical but fundamentally equivalent to placebo-controlled designs with respect to withholding a potentially effective intervention from the control group. We discuss the implications for the ongoing ring vaccination trial and future research.

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Year:  2016        PMID: 26794172      PMCID: PMC4816142          DOI: 10.2105/AJPH.2015.302996

Source DB:  PubMed          Journal:  Am J Public Health        ISSN: 0090-0036            Impact factor:   9.308


  17 in total

1.  What makes clinical research ethical?

Authors:  E J Emanuel; D Wendler; C Grady
Journal:  JAMA       Date:  2000 May 24-31       Impact factor: 56.272

2.  The therapeutic orientation to clinical trials.

Authors:  Franklin G Miller; Donald L Rosenstein
Journal:  N Engl J Med       Date:  2003-04-03       Impact factor: 91.245

3.  Interim results from a phase 3 Ebola vaccine study in Guinea.

Authors:  Philip R Krause
Journal:  Lancet       Date:  2015-08-29       Impact factor: 79.321

4.  A Recombinant Vesicular Stomatitis Virus Ebola Vaccine.

Authors:  Jason A Regules; John H Beigel; Kristopher M Paolino; Jocelyn Voell; Amy R Castellano; Zonghui Hu; Paula Muñoz; James E Moon; Richard C Ruck; Jason W Bennett; Patrick S Twomey; Ramiro L Gutiérrez; Shon A Remich; Holly R Hack; Meagan L Wisniewski; Matthew D Josleyn; Steven A Kwilas; Nicole Van Deusen; Olivier Tshiani Mbaya; Yan Zhou; Daphne A Stanley; Wang Jing; Kirsten S Smith; Meng Shi; Julie E Ledgerwood; Barney S Graham; Nancy J Sullivan; Linda L Jagodzinski; Sheila A Peel; Judie B Alimonti; Jay W Hooper; Peter M Silvera; Brian K Martin; Thomas P Monath; W Jay Ramsey; Charles J Link; H Clifford Lane; Nelson L Michael; Richard T Davey; Stephen J Thomas
Journal:  N Engl J Med       Date:  2015-04-01       Impact factor: 91.245

5.  Vaccine testing. Ebola and beyond.

Authors:  Marc Lipsitch; Nir Eyal; M Elizabeth Halloran; Miguel A Hernán; Ira M Longini; Eli N Perencevich; Rebecca F Grais
Journal:  Science       Date:  2015-04-03       Impact factor: 47.728

Review 6.  Bench to bedside: mapping the moral terrain of clinical research.

Authors:  Steven Joffe; Franklin G Miller
Journal:  Hastings Cent Rep       Date:  2008 Mar-Apr       Impact factor: 2.683

7.  Ebola vaccine trial in west Africa faces criticism.

Authors:  Miriam Shuchman
Journal:  Lancet       Date:  2015-05-12       Impact factor: 79.321

8.  Ebola vaccine trial in Guinea.

Authors:  John-Arne Røttingen
Journal:  Lancet       Date:  2015-05-22       Impact factor: 79.321

9.  Clinical development success rates for investigational drugs.

Authors:  Michael Hay; David W Thomas; John L Craighead; Celia Economides; Jesse Rosenthal
Journal:  Nat Biotechnol       Date:  2014-01       Impact factor: 54.908

10.  Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial.

Authors:  Ana Maria Henao-Restrepo; Ira M Longini; Matthias Egger; Natalie E Dean; W John Edmunds; Anton Camacho; Miles W Carroll; Moussa Doumbia; Bertrand Draguez; Sophie Duraffour; Godwin Enwere; Rebecca Grais; Stephan Gunther; Stefanie Hossmann; Mandy Kader Kondé; Souleymane Kone; Eeva Kuisma; Myron M Levine; Sema Mandal; Gunnstein Norheim; Ximena Riveros; Aboubacar Soumah; Sven Trelle; Andrea S Vicari; Conall H Watson; Sakoba Kéïta; Marie Paule Kieny; John-Arne Røttingen
Journal:  Lancet       Date:  2015-08-03       Impact factor: 79.321

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  15 in total

Review 1.  Improving vaccine trials in infectious disease emergencies.

Authors:  Marc Lipsitch; Nir Eyal
Journal:  Science       Date:  2017-07-14       Impact factor: 47.728

2.  Ebola "Ring" Vaccine Trial Was Ethically Innovative.

Authors:  Bridget G Haire; Morenike O Folayan
Journal:  Am J Public Health       Date:  2016-09       Impact factor: 9.308

3.  Rigorous Clinical Trial Design in Public Health Emergencies Is Essential.

Authors:  Susan S Ellenberg; Gerald T Keusch; Abdel G Babiker; Kathryn M Edwards; Roger J Lewis; Jens D Lundgren; Charles D Wells; Fred Wabwire-Mangen; Keith P W J McAdam
Journal:  Clin Infect Dis       Date:  2018-04-17       Impact factor: 9.079

4.  Vaccine testing for emerging infections: the case for individual randomisation.

Authors:  Nir Eyal; Marc Lipsitch
Journal:  J Med Ethics       Date:  2017-04-10       Impact factor: 2.903

5.  Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic.

Authors:  Emilie Alirol; Annette C Kuesel; Maria Magdalena Guraiib; Vânia de la Fuente-Núñez; Abha Saxena; Melba F Gomes
Journal:  BMC Med Ethics       Date:  2017-06-26       Impact factor: 2.652

6.  Using simulation to aid trial design: Ring-vaccination trials.

Authors:  Matt David Thomas Hitchings; Rebecca Freeman Grais; Marc Lipsitch
Journal:  PLoS Negl Trop Dis       Date:  2017-03-22

7.  [Ethics in clinical trials designs and alternative methods].

Authors:  Carla Saenz; Florencia Luna; Sofía P Salas; Julio Arturo Canario; Jackeline Bravo Chamorro; Ricardo Palacios; Estela Quiroz; Patricia Saidón; Bertha María Villela
Journal:  Rev Panam Salud Publica       Date:  2018-01

8.  Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review.

Authors:  Louise Sigfrid; Katherine Maskell; Peter G Bannister; Sharif A Ismail; Shelui Collinson; Sadie Regmi; Claire Blackmore; Eli Harriss; Kajsa-Stina Longuere; Nina Gobat; Peter Horby; Mike Clarke; Gail Carson
Journal:  BMC Med       Date:  2020-06-25       Impact factor: 8.775

Review 9.  So much at stake: Ethical tradeoffs in accelerating SARSCoV-2 vaccine development.

Authors:  Christine Grady; Seema Shah; Franklin Miller; Marion Danis; Marie Nicolini; Jorge Ochoa; Holly Taylor; Dave Wendler; Annette Rid
Journal:  Vaccine       Date:  2020-08-11       Impact factor: 3.641

10.  Choices in vaccine trial design in epidemics of emerging infections.

Authors:  Rebecca Kahn; Annette Rid; Peter G Smith; Nir Eyal; Marc Lipsitch
Journal:  PLoS Med       Date:  2018-08-07       Impact factor: 11.069

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