Rationale and Ethical Assessment of an Oropharyngeal Gonorrhea Controlled Human Infection Model.

Abstract

Infection with Neisseria gonorrhoeae, the causative agent of gonorrhea, causes significant morbidity worldwide and can have long-term impacts on reproductive health. The greatest global burden of gonorrhea occurs in low- and middle-income settings. Global public health significance is increasing due to rising antimicrobial resistance, which threatens future gonorrhea management. The oropharynx is an important asymptomatic reservoir for gonorrhea transmission and a high-risk site for development of antimicrobial resistance 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 gonorrhea urethritis CHIM has been used since the 1980s with no reported serious adverse events. Here, we describe the rationale for an oropharyngeal gonorrhea CHIM, including analysis of potential ethical issues that should inform the development of this novel study design.