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.