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

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 ethica...

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Published inClinical trials (London, England) Vol. 19; no. 1; pp. 116 - 118
Main 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
Format Journal Article
LanguageEnglish
Published London, England SAGE Publications 01.02.2022
Subjects
Host-Pathogen Interactions
Humans
Inpatients
enteric infection
vaccine
Controlled human infection models
diarrheal disease
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Summary: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.
ISSN:1740-7745
1740-7753
DOI:10.1177/17407745211052473