Design of vaccine efficacy trials during public health emergencies

Author:

Dean Natalie E.1,Gsell Pierre-Stéphane2,Brookmeyer Ron3ORCID,De Gruttola Victor4,Donnelly Christl A.56,Halloran M. Elizabeth78ORCID,Jasseh Momodou9,Nason Martha10ORCID,Riveros Ximena2,Watson Conall H.11ORCID,Henao-Restrepo Ana Maria2,Longini Ira M.1ORCID

Affiliation:

1. Department of Biostatistics, University of Florida, Gainesville, FL, USA.

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.

Abstract

This Perspective describes key considerations for the design and analysis of candidate vaccine trials during public health emergencies.

Funder

National Institutes of Health

Medical Research Council

National Institute of Allergy and Infectious Diseases

National Institute for Health Research

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference40 articles.

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2. WHO R&D Blueprint: a global coordination mechanism for R&D preparedness

3. WHO R&D Blueprint: List of Blueprint priority diseases; www.who.int/blueprint/priority-diseases/en/.

4. Statistics and logistics: Design of Ebola vaccine trials in West Africa

5. National Academies of Sciences Engineering and Medicine Integrating Clinical Research into Epidemic Response: The Ebola Experience (National Academies Press 2017).

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