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

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

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.

Original language	English
Pages (from-to)	116-118
Number of pages	3
Journal	Clinical Trials
Volume	19
Issue number	1
DOIs	https://doi.org/10.1177/17407745211052473
State	Published - Feb 2022
Externally published	Yes

Keywords

Controlled human infection models
diarrheal disease
enteric infection
vaccine

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Porter, C. K., Detizio, K. J., Maier, N., Testa, K. J., Talaat, K. R., Chen, W. H., Lyon, C. E., Gutierrez, R. L., Frenck, R., Isidean, S. D., Kaminski, R. W., Alcala, A. N., Hanevik, K., Sawe, F., Kirkpatrick, B. D., & Louis Bourgeois, A. (2022). A site assessment tool for inpatient controlled human infection models for enteric disease pathogens. Clinical Trials, 19(1), 116-118. https://doi.org/10.1177/17407745211052473

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title = "A site assessment tool for inpatient controlled human infection models for enteric disease pathogens",

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",

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

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year = "2022",

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doi = "10.1177/17407745211052473",

language = "English",

volume = "19",

pages = "116--118",

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Porter, CK, Detizio, KJ, Maier, N, Testa, KJ, Talaat, KR, Chen, WH, Lyon, CE, Gutierrez, RL, Frenck, R, Isidean, SD, Kaminski, RW, Alcala, AN, Hanevik, K, Sawe, F, Kirkpatrick, BD & Louis Bourgeois, A 2022, 'A site assessment tool for inpatient controlled human infection models for enteric disease pathogens', Clinical Trials, vol. 19, no. 1, pp. 116-118. https://doi.org/10.1177/17407745211052473

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AU - Porter, Chad K.

AU - Detizio, Katherine J.

AU - Maier, Nicole

AU - Testa, Kayla J.

AU - Talaat, Kawsar R.

AU - Chen, Wilbur H.

AU - Lyon, Caroline E.

AU - Gutierrez, Ramiro L.

AU - Frenck, Robert

AU - Isidean, Sandra D.

AU - Kaminski, Robert W.

AU - Alcala, Ashley N.

AU - Hanevik, Kurt

AU - Sawe, Frederick

AU - Kirkpatrick, Beth D.

AU - Louis Bourgeois, A.

PY - 2022/2

Y1 - 2022/2

N2 - 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.

AB - 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.

KW - Controlled human infection models

KW - diarrheal disease

KW - enteric infection

KW - vaccine

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VL - 19

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JO - Clinical Trials

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ER -

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

Abstract

Keywords

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