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

Controlled human infection models diarrheal disease enteric infection vaccine

Journal

Clinical trials (London, England)
ISSN: 1740-7753
Titre abrégé: Clin Trials
Pays: England
ID NLM: 101197451

Informations de publication

Date de publication:
02 2022
Historique:
pubmed: 29 10 2021
medline: 4 5 2022
entrez: 28 10 2021
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 34708664
doi: 10.1177/17407745211052473
doi:

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

116-118

Auteurs

Chad K Porter (CK)

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

Katherine J Detizio (KJ)

Enteric Diseases Department, Naval Medical Research Center, Silver Spring, MD, USA.
Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.

Nicole Maier (N)

PATH, Washington, DC, USA.

Kayla J Testa (KJ)

Enteric Diseases Department, Naval Medical Research Center, Silver Spring, MD, USA.
Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.

Kawsar R Talaat (KR)

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

Wilbur H Chen (WH)

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

Caroline E Lyon (CE)

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

Ramiro L Gutierrez (RL)

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

Robert Frenck (R)

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

Sandra D Isidean (SD)

Enteric Diseases Department, Naval Medical Research Center, Silver Spring, MD, USA.
Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.

Robert W Kaminski (RW)

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

Ashley N Alcala (AN)

Enteric Diseases Department, Naval Medical Research Center, Silver Spring, MD, USA.
Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.

Kurt Hanevik (K)

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

Frederick Sawe (F)

Kenya Medical Research Institute and United States Army Medical Research Directorate-Africa, Kericho, Kenya.
Henry M. Jackson Foundation Medical Research International, Bethesda, MD, USA.

Beth D Kirkpatrick (BD)

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

A Louis Bourgeois (A)

PATH, Washington, DC, USA.

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Classifications MeSH