Rationale and ethical assessment of an oropharyngeal gonorrhoea controlled human infection model

Eloise Williams; Jane S Hocking; Christopher K Fairley; Marcus Y Chen; Deborah A Williamson; James S McCarthy; Euzebiusz Jamrozik

doi:10.1093/infdis/jiaf029

Rationale and ethical assessment of an oropharyngeal gonorrhoea controlled human infection model

Eloise Williams^*, Jane S Hocking, Christopher K Fairley, Marcus Y Chen, Deborah A Williamson, James S McCarthy, Euzebiusz Jamrozik

^*Corresponding author for this work

School of Medicine

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

Abstract

Infection with Neisseria gonorrhoeae, the causative agent of gonorrhoea, causes significant morbidity worldwide and can have long-term impacts on reproductive health. The greatest global burden of gonorrhoea occurs in low- and middle-income settings. Global public health significance is increasing due to rising antimicrobial resistance (AMR), which threatens future gonorrhoea management. The oropharynx is an important asymptomatic reservoir for gonorrhoea transmission and a high-risk site for development of AMR and treatment failure. Controlled human infection model (CHIM) studies using N. gonorrhoeae may provide a means to accelerate the development of urgently needed therapeutics, vaccines and other biomedical prevention strategies. A gonorrhoea urethritis CHIM has been used since the 1980s with no reported serious adverse events. Here, we describe the rationale for an oropharyngeal gonorrhoea CHIM, including analysis of potential ethical issues that should inform the development of this novel study design.

Original language	English
Article number	jiaf029
Pages (from-to)	841-848
Number of pages	8
Journal	Journal of Infectious Diseases
Volume	231
Issue number	4
Early online date	18 Jan 2025
DOIs	https://doi.org/10.1093/infdis/jiaf029
Publication status	Published - 15 Apr 2025

Keywords

Controlled human infection model
Ethics
Gonorrhea
Sexually transmitted infection
Antimicrobial resistance

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Williams-2025-Rationale-and-ethical-JID-231-841-CCBYNCND
Copyright © The Author(s) 2025. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited.
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title = "Rationale and ethical assessment of an oropharyngeal gonorrhoea controlled human infection model",

abstract = "Infection with Neisseria gonorrhoeae, the causative agent of gonorrhoea, causes significant morbidity worldwide and can have long-term impacts on reproductive health. The greatest global burden of gonorrhoea occurs in low- and middle-income settings. Global public health significance is increasing due to rising antimicrobial resistance (AMR), which threatens future gonorrhoea management. The oropharynx is an important asymptomatic reservoir for gonorrhoea transmission and a high-risk site for development of AMR and treatment failure. Controlled human infection model (CHIM) studies using N. gonorrhoeae may provide a means to accelerate the development of urgently needed therapeutics, vaccines and other biomedical prevention strategies. A gonorrhoea urethritis CHIM has been used since the 1980s with no reported serious adverse events. Here, we describe the rationale for an oropharyngeal gonorrhoea CHIM, including analysis of potential ethical issues that should inform the development of this novel study design.",

keywords = "Controlled human infection model, Ethics, Gonorrhea, Sexually transmitted infection, Antimicrobial resistance",

author = "Eloise Williams and Hocking, {Jane S} and Fairley, {Christopher K} and Chen, {Marcus Y} and Williamson, {Deborah A} and McCarthy, {James S} and Euzebiusz Jamrozik",

note = "Funding: This work was supported by a Clinician Researchers: Applied Research in Health Grant from the Medical Research Future Fund (MRFAR000354); a postgraduate scholarship from the National Health and Medical Research Council (GNT2005380 to E. W.); Investigator Grants from the National Health and Medical Research Council (GNT2025960 to J. S. H., GNT2025840 to M. Y. C., GNT1174555 to D. A. W.); and Leadership Investigator Grants from the National Health and Medical Research Council (GNT1172900 to C. K. F., GNT2016396 to J. S. M.).",

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AU - McCarthy, James S

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N2 - Infection with Neisseria gonorrhoeae, the causative agent of gonorrhoea, causes significant morbidity worldwide and can have long-term impacts on reproductive health. The greatest global burden of gonorrhoea occurs in low- and middle-income settings. Global public health significance is increasing due to rising antimicrobial resistance (AMR), which threatens future gonorrhoea management. The oropharynx is an important asymptomatic reservoir for gonorrhoea transmission and a high-risk site for development of AMR and treatment failure. Controlled human infection model (CHIM) studies using N. gonorrhoeae may provide a means to accelerate the development of urgently needed therapeutics, vaccines and other biomedical prevention strategies. A gonorrhoea urethritis CHIM has been used since the 1980s with no reported serious adverse events. Here, we describe the rationale for an oropharyngeal gonorrhoea CHIM, including analysis of potential ethical issues that should inform the development of this novel study design.

AB - Infection with Neisseria gonorrhoeae, the causative agent of gonorrhoea, causes significant morbidity worldwide and can have long-term impacts on reproductive health. The greatest global burden of gonorrhoea occurs in low- and middle-income settings. Global public health significance is increasing due to rising antimicrobial resistance (AMR), which threatens future gonorrhoea management. The oropharynx is an important asymptomatic reservoir for gonorrhoea transmission and a high-risk site for development of AMR and treatment failure. Controlled human infection model (CHIM) studies using N. gonorrhoeae may provide a means to accelerate the development of urgently needed therapeutics, vaccines and other biomedical prevention strategies. A gonorrhoea urethritis CHIM has been used since the 1980s with no reported serious adverse events. Here, we describe the rationale for an oropharyngeal gonorrhoea CHIM, including analysis of potential ethical issues that should inform the development of this novel study design.

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Rationale and ethical assessment of an oropharyngeal gonorrhoea controlled human infection model

Abstract

Keywords

UN SDGs

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