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An oropharyngeal gonorrhoea controlled human infection model: a provisional protocol using a novel Neisseria
Eloise Williams1,2,3, Georgina L Pollock1,4, David J Price1,5
1Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, 3000, Australia.
Introduction:
Gonorrhoea is a sexually transmissable infection caused by Neisseria gonorrhoeae that causes a significant global burden of disease. Urogenital infection can result in long-term impacts on reproductive, perinatal, and neonatal health. Little progress has been made in the public health control of gonorrhoea, and novel preventative strategies are urgently needed. Furthermore, future gonorrhoea management is threatened by increasing antimicrobial resistance (AMR). Oropharyngeal gonorrhoea is usually asymptomatic; likely plays an important role in development of AMR; and is a high-risk site for treatment failure. Here, we describe a protocol for an oropharyngeal gonorrhoea controlled human infection model (CHIM) that has been designed to maximize participant safety, with the aim of developing this as a platform to accelerate prevention and treatment strategies.
Methods And Analysis:
This dose-escalation CHIM study will enrol 20-35 healthy adult volunteers aged 18 to 50 years who were assigned male at birth and only have sex with people assigned male at birth. The primary objectives are to determine i) the safety and tolerability of an oropharyngeal gonorrhoea CHIM; and, ii) the minimum infectious dose of isolate AUSMDU00053933 required for 60-80% of participants to develop oropharyngeal N. gonorrhoeae infection. Secondary and exploratory endpoints include description of clinical, immunological, microbiological and pharmacometric responses. Participants will be monitored daily as outpatients during the five-day experimental infection phase. All participants will be treated with antibiotics, and followed up for three months. Statistical analysis and dose escalation/de-escalation decisions will follow a model-based continual reassessment method in a Bayesian statistical framework.
Ethics And Dissemination:
After scientific peer review of this provisional protocol, a detailed protocol will be submitted for human research ethics committee assessment. Protocol development was informed by feedback from community engagement. Study findings will be disseminated in peer-reviewed journals and at scientific meetings, with summaries provided to relevant stakeholders.
