Participant Safety and Ethics

Uses

Risks & contraindications

Other

Highlighted claims

• Antibiotic treatment is triggered by participant request, purulent urethral discharge, or reaching day 10. — 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
• The study has independent DSMB oversight and follows major human-subjects and clinical research ethics standards. — 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
• A study physician is available 24 hours per day during challenge periods. — 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
• Participants are screened for complement deficiency because it is a risk factor for disseminated gonorrhea. — 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
• Women are excluded from the trial because of the risk of ascending infection. — 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