A site assessment tool for inpatient controlled human infection models for enteric disease pathogens. (February 2022)

• Record Type: Journal Article
• Authors: Porter, Chad K; Detizio, Katherine J; Maier, Nicole; Testa, Kayla J; Talaat, Kawsar R; Chen, Wilbur H; Lyon, Caroline E; Gutierrez, Ramiro L; Frenck, Robert; Isidean, Sandra D; Kaminski, Robert W; Alcala, Ashley N; Hanevik, Kurt; Sawe, Frederick; Kirkpatrick, Beth D; Louis Bourgeois, A
• Is Part Of: Clinical trials. Volume 19:Number 1(2022)
• Page Start: 116
• Page End: 118
• Publication Date: 2022-02
• Subjects: Controlled human infection models -- enteric infection -- diarrheal disease -- vaccine; 615.5072405
• DOI: 10.1177/17407745211052473
• Languages: English
• ISSNs: 1740-7745

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.