Efficacy of the serogroup B Neisseria meningitidis vaccine (4CMenB) in preventing experimental Neisseria gonorrhoeae urethral infection: a double-blind randomised controlled human challenge study protocol.

INTRODUCTION: using the human male urethral challenge model. METHODS AND ANALYSIS: infection in each study group to determine the efficacy of standard immunisation with 4CMenB in preventing experimental gonococcal infection. The secondary objective is to determine whether 4CMenB vaccinations change or delay the onset of urethritis symptoms. ETHICS AND DISSEMINATION: All participants enrolled in the study provided informed consent twice. This study has been reviewed and approved by the University of North Carolina at Chapel Hill Institutional Review Board (#21-0498). Data collection for this study is ongoing. TRIAL REGISTRATION NUMBER: NCT05294588.