Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseri… (NCT05294588) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae
United States65 participantsStarted 2022-04-18
Plain-language summary
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.
Who can participate
Age range
18 Years – 35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 his…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Infectivity of N. gonorrhoeae inoculum
Timeframe: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)