Division of Microbiology and Infectious Diseases, (DMID) 21-0018: Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae
This is a double-blind randomized controlled trial to test whether the group B meningitis vaccine 4 component Neisseria meningitidis serogroup B vaccine (BEXSEROTM) (4C-MenB), trade name Bexsero™), currently approved for use by the United States Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC) for protection from Neisseria meningitidis infections, also protects from Neisseria gonorrhoeae infection using controlled human experimental infection to test protection. The information the investigator learn by doing this study may also help to develop a vaccine that protects individuals from having gonorrhea infection. The study population will consist of male participants \> 18 and \< 36 years old, living in central North Carolina, in general good health without a history of 4C-MenB vaccination. Approximately 120-140 participants will be enrolled. Participants will receive 2 doses of vaccine (2 doses of 4C-MenB or 2 comparator vaccines- seasonal influenza and tetanus/diptheria booster) as intramuscular injections, and then one intraurethral challenge with Neisseria gonorrhoeae. Following the challenge, participants will cross-over and receive two doses of vaccines not received prior to challenge (2 doses of 4CMenB or the 2 comparator vaccines- seasonal influenza and tetanus/diptheria booster) All participants receive all vaccinations by the end of the study and all vaccines used in this study are licensed and FDA-approved.
⁃ Participants must meet all the inclusion criteria to participate in the study.
• Assigned male at birth and now ≥ 18 and \< 36 years old
• No history of prior Neisseria meningitidis serogroup B (MenB) vaccination
• Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number)
• Willingness to provide written informed consent
• Informed consent obtained and signed
• Able and willing to attend all study visits
• Able and willing to abstain from all sexual activity involving contact with the participant's penis, urine, or semen and a person other than the participant during experimental gonococcal infection phase until the follow-up test for gonorrhea is negative
• Able and willing to abstain from scheduled immunizations other than those provided through the study, between enrollment and completion of Ng challenge.
• No clinically significant abnormalities on physical exam
• Urinalysis: leukocyte esterase and WBC values within normal limits
• 50% complement hemolytic activity (CH50) within normal limits (WNL)
• Negative HIV and syphilis test results at the screening visit
• Denies history of bleeding diathesis
• Denies history of seizures (due to reports of seizures with ciprofloxacin), history of childhood febrile seizure acceptable
• Denies history of cancer, except basal cell carcinoma of the skin \>5 years ago
• Denies current drug abuse that would interfere with study activities
• Denies history of penile, urethral, prostate, testis and associated structures surgery (varicocele repair, vasectomy, and vasectomy repair are acceptable if greater than 1 year prior to enrollment)