Flashtalk 25th International Pathogenic Neisseria Conference 2026

Controlled Human Infection Studies for Gonorrhoea: Current Status and Future Directions: Outputs from the Inaugural Gonococcal Challenge Network Meeting (#035)

Susanne H Hodgson 1 , Joseph Duncan 2 , James S McCarthy 3 , Eloise Williams 3 , Scott Gray-Owen Scott Gray-Owen 4 , Sanjay Ram 5 , Kate L Seib 6 , Eric PF Chow 7
  1. University of Oxford, Oxford, United Kingdom
  2. Department of Medicine, The University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA
  3. Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
  4. Department of Molecular Genetics, University of Toronto, Toronto, Canada
  5. Division of Infectious Diseases and Immunology, University of Massachusetts Chan Medical School, Worcester, USA
  6. Institute for Biomedicine and Glycomics, Griffith University, Gold Coast, QLD, Australia
  7. Melbourne Sexual Health Centre, Alfred Health, Melbourne, Australia

Background: Gonorrhoea, a bacterial sexually transmitted infection caused by Neisseria gonorrhoeae, is a major global public health concern due to rising incidence and increasing antimicrobial resistance (AMR). The absence of a licensed vaccine and limitations of animal models have impeded progress in the understanding of pathogenesis, immunity and development of novel therapeutics and vaccines. Controlled human infection studies (CHIS) offer a powerful experimental approach to accelerate vaccine and antimicrobial development and improve understanding of host–pathogen interactions.

Methods: An international, multidisciplinary stakeholder workshop was convened in Oxford, UK in March 2025 to review current gonorrhoea CHIS activity, define research priorities and establish consensus standards for future studies. Representatives from academia, industry, non-governmental organisations and participant advocacy groups reviewed evidence and developed consensus statements through structured discussion.

Results: Existing urogenital gonorrhoea CHIS in men have demonstrated safety and generated key insights into pathogenesis and immune responses but remain limited in scale and scope. Consensus highlighted the continued value of CHIS with well-characterised strains such as FA1090, while supporting careful selection and characterisation of novel strains. Standardised, risk-based approaches to inoculum manufacture and quality assurance were recommended to enhance reproducibility and scalability. Expansion of CHIS to include additional anatomical sites and novel populations, including individuals with female reproductive anatomy, was identified as scientifically valuable but requiring careful ethical and safety evaluation. CHIS were recognised as uniquely positioned to advance vaccine and antimicrobial development by enabling early efficacy assessment, identification of correlates of protection and optimisation of treatment and prevention strategies.

Conclusions: Gonorrhoea CHIS are an underutilised but valuable research tool with potential to accelerate progress against gonorrhoea and AMR. With robust ethical oversight, community engagement and international collaboration, expanded and harmonised CHIS could substantially advance prevention and treatment strategies.