A site assessment tool for inpatient controlled human infection models for enteric disease pathogens

Author:

Porter Chad K1ORCID,Detizio Katherine J12,Maier Nicole3,Testa Kayla J12,Talaat Kawsar R4,Chen Wilbur H5,Lyon Caroline E6,Gutierrez Ramiro L1,Frenck Robert7,Isidean Sandra D12,Kaminski Robert W8,Alcala Ashley N12ORCID,Hanevik Kurt910,Sawe Frederick1112,Kirkpatrick Beth D6,Louis Bourgeois A3

Affiliation:

1. Enteric Diseases Department, Naval Medical Research Center, Silver Spring, MD, USA

2. Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA

3. PATH, Washington, DC, USA

4. Center for Immunization Research, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA

5. Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA

6. Vaccine Testing Center, Larner College of Medicine, The University of Vermont, Burlington, VT, USA

7. Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA

8. Bacterial Disease Branch, Walter Reed Army Institute of Research, Silver Spring, MD, USA

9. Norwegian National Advisory Unit on Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway

10. Department of Clinical Science, University of Bergen, Bergen, Norway

11. Kenya Medical Research Institute and United States Army Medical Research Directorate-Africa, Kericho, Kenya

12. Henry M. Jackson Foundation Medical Research International, Bethesda, MD, USA

Abstract

The use of the controlled human infection model to facilitate product development and to advance understanding of host-pathogen interactions is of increasing interest. While administering a virulent (or infective) organism to a susceptible host necessitates an ongoing evaluation of safety and ethical considerations, a central theme in conducting these studies in a safe and ethical manner that yields actionable data is their conduct in facilities well-suited to address their unique attributes. To that end, we have developed a framework for evaluating potential sites in which to conduct inpatient enteric controlled human infection model to ensure consistency and increase the likelihood of success.

Funder

Bill & Melinda Gates Foundation

Publisher

SAGE Publications

Subject

Pharmacology,General Medicine

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