Design of vaccine efficacy trials during public health emergencies

Affiliations

¹ Department of Biostatistics, University of Florida, Gainesville, FL, USA. nataliedean@ufl.edu ilongini@ufl.edu.
² World Health Organization, Geneva, Switzerland.
³ Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA.
⁴ Department of Biostatistics, Harvard University, Boston, MA, USA.
⁵ Department of Statistics, University of Oxford, Oxford, UK.
⁶ MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, School of Public Health, Imperial College London, London, UK.
⁷ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
⁸ Department of Biostatistics, University of Washington, Seattle, WA, USA.
⁹ Medical Research Council, The Gambia at London School of Hygiene and Tropical Medicine, Fajara, The Gambia.
¹⁰ Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
¹¹ Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.

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

Review

Design of vaccine efficacy trials during public health emergencies

Natalie E Dean et al. Sci Transl Med. 2019.

. 2019 Jul 3;11(499):eaat0360.

doi: 10.1126/scitranslmed.aat0360.

Authors

Affiliations

¹ Department of Biostatistics, University of Florida, Gainesville, FL, USA. nataliedean@ufl.edu ilongini@ufl.edu.
² World Health Organization, Geneva, Switzerland.
³ Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA.
⁴ Department of Biostatistics, Harvard University, Boston, MA, USA.
⁵ Department of Statistics, University of Oxford, Oxford, UK.
⁶ MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, School of Public Health, Imperial College London, London, UK.
⁷ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
⁸ Department of Biostatistics, University of Washington, Seattle, WA, USA.
⁹ Medical Research Council, The Gambia at London School of Hygiene and Tropical Medicine, Fajara, The Gambia.
¹⁰ Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
¹¹ Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.

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

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.

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Figures

**Figure 1:**
Schematic of randomized trial designs

See this image and copyright information in PMC

References

1. Moon S, Sridhar D, Pate MA, Jha AK, Clinton C, Delaunay S, Edwin V, Fallah M, Fidler DP, Garrett L, Goosby E, Gostin LO, Heymann DL, Lee K, Leung GM, Morrison JS, Saavedra J, Tanner M, Leigh JA, Hawkins B, Woskie LR, Piot P, Will Ebola change the game? Ten essential reforms before the next pandemic. The report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola, Lancet 386, 2204–2221 (2015). - PMC - PubMed
1. Kieny P, Salama P, WHO R&D Blueprint: a global coordination mechanism for R&D preparedness, Lancet 389, 2469–2470 (2017). - PubMed
1. WHO, R&D Blueprint ∣ List of Blueprint priority diseases, (available at http://www.who.int/blueprint/priority-diseases/en/). - PubMed
1. Nason M, Statistics and logistics: Design of Ebola vaccine trials in West Africa, Clin. Trials 13, 87–91 (2016). - PubMed
1. Vandebosch A, Mogg R, Goeyvaerts N, Truyers C, Watson-Jones D, Herrera-Taracena G, Simulation-guided phase 3 trial design to evaluate vaccine effectiveness to prevent Ebola virus disease infection: Statistical considerations , design rationale , and challenges, Clin. Trials 13, 57–65 (2016). - PubMed

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Design of vaccine efficacy trials during public health emergencies

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Design of vaccine efficacy trials during public health emergencies

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