Literature DB >> 31270270

Design of vaccine efficacy trials during public health emergencies.

Natalie E Dean1, Pierre-Stéphane Gsell2, Ron Brookmeyer3, Victor De Gruttola4, Christl A Donnelly5,6, M Elizabeth Halloran7,8, Momodou Jasseh9, Martha Nason10, Ximena Riveros2, Conall H Watson11, Ana Maria Henao-Restrepo2, Ira M Longini1.   

Abstract

Public health emergencies, such as an Ebola disease outbreak, provide a complex and challenging environment for the evaluation of candidate vaccines. Here, we outline the need for flexible and responsive vaccine trial designs to be used in public health emergencies, and we summarize recommendations for their use in this setting.
Copyright © 2019 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.

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Year:  2019        PMID： 31270270      PMCID： PMC6613811          DOI： 10.1126/scitranslmed.aat0360

Source DB:  PubMed          Journal:  Sci Transl Med        ISSN： 1946-6234            Impact factor:   17.956


  31 in total

Review 1.  Design and analysis issues in cluster-randomized trials of interventions against infectious diseases.

Authors:  R J Hayes; N D Alexander; S Bennett; S N Cousens
Journal:  Stat Methods Med Res       Date:  2000-04       Impact factor: 3.021

2.  Toward Causal Inference With Interference.

Authors:  Michael G Hudgens; M Elizabeth Halloran
Journal:  J Am Stat Assoc       Date:  2008-06       Impact factor: 5.033

3.  Simulation-guided phase 3 trial design to evaluate vaccine effectiveness to prevent Ebola virus disease infection: Statistical considerations, design rationale, and challenges.

Authors:  An Vandebosch; Robin Mogg; Nele Goeyvaerts; Carla Truyers; Brian Greenwood; Debby Watson-Jones; Guillermo Herrera-Taracena; Wim Parys; Tony Vangeneugden
Journal:  Clin Trials       Date:  2016-01-14       Impact factor: 2.486

4.  Field evaluation of vaccine efficacy.

Authors:  W A Orenstein; R H Bernier; T J Dondero; A R Hinman; J S Marks; K J Bart; B Sirotkin
Journal:  Bull World Health Organ       Date:  1985       Impact factor: 9.408

5.  DESIGN OF VACCINE TRIALS DURING OUTBREAKS WITH AND WITHOUT A DELAYED VACCINATION COMPARATOR.

Authors:  Natalie E Dean; M Elizabeth Halloran; Ira M Longini
Journal:  Ann Appl Stat       Date:  2018-03-09       Impact factor: 2.083

6.  Implementing an Ebola Vaccine Study - Sierra Leone.

Authors:  Marc-Alain Widdowson; Stephanie J Schrag; Rosalind J Carter; Wendy Carr; Jennifer Legardy-Williams; Laura Gibson; Durodami R Lisk; Mohamed I Jalloh; Donald A Bash-Taqi; Samuel A Sheku Kargbo; Ayesha Idriss; Gibrilla F Deen; James B W Russell; Wendi McDonald; Alison P Albert; Michelle Basket; Amy Callis; Victoria M Carter; Kelli R Clifton Ogunsanya; Julianne Gee; Robert Pinner; Barbara E Mahon; Susan T Goldstein; Jane F Seward; Mohamed Samai; Anne Schuchat
Journal:  MMWR Suppl       Date:  2016-07-08

7.  Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report.

Authors:  Pierre-Stéphane Gsell; Anton Camacho; Adam J Kucharski; Conall H Watson; Aminata Bagayoko; Séverine Danmadji Nadlaou; Natalie E Dean; Abdourahamane Diallo; Abdourahmane Diallo; Djidonou A Honora; Moussa Doumbia; Godwin Enwere; Elizabeth S Higgs; Thomas Mauget; Diakite Mory; Ximena Riveros; Fofana Thierno Oumar; Mosoka Fallah; Alhassane Toure; Andrea S Vicari; Ira M Longini; W J Edmunds; Ana Maria Henao-Restrepo; Marie Paule Kieny; Sakoba Kéïta
Journal:  Lancet Infect Dis       Date:  2017-10-09       Impact factor: 25.071

8.  CEPI-a new global R&D organisation for epidemic preparedness and response.

Authors:  Børge Brende; Jeremy Farrar; Diane Gashumba; Carlos Moedas; Trevor Mundel; Yasuhisa Shiozaki; Harsh Vardhan; Johanna Wanka; John-Arne Røttingen
Journal:  Lancet       Date:  2017-01-19       Impact factor: 79.321

9.  The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola.

Authors: 
Journal:  BMJ       Date:  2015-07-27

10.  Estimating the probability of demonstrating vaccine efficacy in the declining Ebola epidemic: a Bayesian modelling approach.

Authors:  Anton Camacho; Rosalind M Eggo; Sebastian Funk; Conall H Watson; Adam J Kucharski; W John Edmunds
Journal:  BMJ Open       Date:  2015-12-15       Impact factor: 2.692
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  22 in total

1.  Statistical Properties of Stepped Wedge Cluster-Randomized Trials in Infectious Disease Outbreaks.

Authors:  Lee Kennedy-Shaffer; Marc Lipsitch
Journal:  Am J Epidemiol       Date:  2020-11-02       Impact factor: 4.897

2.  Potential test-negative design study bias in outbreak settings: application to Ebola vaccination in Democratic Republic of Congo.

Authors:  Carl A B Pearson; W John Edmunds; Thomas J Hladish; Rosalind M Eggo
Journal:  Int J Epidemiol       Date:  2022-02-18       Impact factor: 7.196

3.  Quantifying Efficiency Gains of Innovative Designs of Two-Arm Vaccine Trials for COVID-19 Using an Epidemic Simulation Model.

Authors:  Rob Johnson; Chris Jackson; Anne Presanis; Sofia S Villar; Daniela De Angelis
Journal:  Stat Biopharm Res       Date:  2021-07-30       Impact factor: 1.452

4.  Commentary on the role of statisticians in pandemics.

Authors:  Ron Brookmeyer
Journal:  Stat Med       Date:  2021-05-20       Impact factor: 2.373

5.  Acceptance of COVID-19 vaccine and associated factors among health professionals working in Hospitals of South Gondar Zone, Northwest Ethiopia.

Authors:  Alemu Degu Ayele; Netsanet Temesgen Ayenew; Lebeza Alemu Tenaw; Bekalu Getnet Kassa; Enyew Dagnew Yehuala; Eden Workneh Aychew; Gedefaye Nibret Mihretie; Habtamu Gebrehana Belay
Journal:  Hum Vaccin Immunother       Date:  2022-02-04       Impact factor: 3.452

6.  The ring vaccination trial design for the estimation of vaccine efficacy and effectiveness during infectious disease outbreaks.

Authors:  Natalie E Dean; Ira M Longini
Journal:  Clin Trials       Date:  2022-01-21       Impact factor: 2.599

7.  An online decision tree for vaccine efficacy trial design during infectious disease epidemics: The InterVax-Tool.

Authors:  Steven E Bellan; Rosalind M Eggo; Pierre-Stéphane Gsell; Adam J Kucharski; Natalie E Dean; Richard Donohue; Matt Zook; W John Edmunds; Frank Odhiambo; Ira M Longini; Marc Brisson; Barbara E Mahon; Ana Maria Henao-Restrepo
Journal:  Vaccine       Date:  2019-06-24       Impact factor: 3.641

Review 8.  Vaccines for Perinatal and Congenital Infections-How Close Are We?

Authors:  Tulika Singh; Claire E Otero; Katherine Li; Sarah M Valencia; Ashley N Nelson; Sallie R Permar
Journal:  Front Pediatr       Date:  2020-12-15       Impact factor: 3.418

9.  Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks.

Authors:  Natalie E Dean; Pierre-Stéphane Gsell; Ron Brookmeyer; Forrest W Crawford; Christl A Donnelly; Susan S Ellenberg; Thomas R Fleming; M Elizabeth Halloran; Peter Horby; Thomas Jaki; Philip R Krause; Ira M Longini; Sabue Mulangu; Jean-Jacques Muyembe-Tamfum; Martha C Nason; Peter G Smith; Rui Wang; Ana M Henao-Restrepo; Victor De Gruttola
Journal:  N Engl J Med       Date:  2020-04-02       Impact factor: 176.079

10.  Ensemble forecast modeling for the design of COVID-19 vaccine efficacy trials.

Authors:  Natalie E Dean; Ana Pastore Y Piontti; Zachary J Madewell; Derek A T Cummings; Matthew D T Hitchings; Keya Joshi; Rebecca Kahn; Alessandro Vespignani; M Elizabeth Halloran; Ira M Longini
Journal:  Vaccine       Date:  2020-09-15       Impact factor: 3.641
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