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

Chad K Porter; Katherine J Detizio; Nicole Maier; Kayla J Testa; Kawsar R Talaat; Wilbur H Chen; Caroline E Lyon; Ramiro L Gutierrez; Robert Frenck; Sandra D Isidean; Robert W Kaminski; Ashley N Alcala; Kurt Hanevik; Frederick Sawe; Beth D Kirkpatrick; A Louis Bourgeois

doi:10.1177/17407745211052473

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

Clin Trials. 2022 Feb;19(1):116-118. doi: 10.1177/17407745211052473. Epub 2021 Oct 28.

Authors

Chad K Porter¹, Katherine J Detizio^{1

2}, Nicole Maier³, Kayla J Testa^{1

2}, Kawsar R Talaat⁴, Wilbur H Chen⁵, Caroline E Lyon⁶, Ramiro L Gutierrez¹, Robert Frenck⁷, Sandra D Isidean^{1

2}, Robert W Kaminski⁸, Ashley N Alcala^{1

2}, Kurt Hanevik^{9

10}, Frederick Sawe^{11

12}, Beth D Kirkpatrick⁶, A Louis Bourgeois³

Affiliations

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.

PMID: 34708664
DOI: 10.1177/17407745211052473

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.

Keywords: Controlled human infection models; diarrheal disease; enteric infection; vaccine.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Host-Pathogen Interactions*
Humans
Inpatients*