Could a meningitis shot also stop gonorrhea?
NCT ID NCT05294588
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a vaccine already approved for meningitis B (Bexsero) can also protect against gonorrhea infection. Healthy men aged 18–35 received either the meningitis vaccine or a placebo, then were exposed to the gonorrhea bacteria in a controlled setting. The goal was to see if the vaccine reduced infection rates. Results could help develop a new gonorrhea vaccine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 4C-MenB (Bexsero) vaccine
- What this could lead to
- If it works, this could point toward a vaccine that protects against gonorrhea, a common sexually transmitted infection.
- What could go wrong
- This is a small, early-phase trial in healthy men only. The vaccine is designed for meningitis, not gonorrhea, so it may not provide strong protection. Results may not apply to women or other populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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65 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 35 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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) Exclusion Criteria: Participants meeting any of the exclusion criteria at initial screening and screening prior to Ng challenge will be excluded from study participation. If the results of Complete blood count (CBC), serum alanine transaminase (ALT), serum creatinine, or urinalysis obtained at initial screening are outside acceptable limits, and the clinician judges the deviation unlikely to be clinically relevant, one-time repeat screening is permitted. Acceptable laboratory values are presented in Appendix B.15 * Student or employee under the direct supervision of any of the study investigators * Any known immunodeficiencies, including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection * A history of prior confirmed N. meningitidis infection * Hemophilia or other bleeding diatheses. * Autoimmune disorders; mild autoimmune disorders, such as eczema, are not exclusionary and will be determined by the study physician. * Unstable psychiatric condition (defined as receiving either \<3 months of the same medication (and dose) or a decompensating event during the previous 3 months) or psychiatric condition that, in the opinion of the investigator, will compromise the participant's ability to comply with protocol requirements * Known anatomic abnormality of the urethra or urethral meatus (granular hypospadias is not exclusionary if the study physician believes that the urethral location will not interfere with inoculation catheter insertion) * Any immunization in 28 days prior to enrollment * Self-reported treatment for cancer within the past year * Receipt of anticoagulants (aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) are acceptable) within 14 days prior to study entry. * Use of any systemic immunomodulatory treatment, systemic corticosteroids, (inhaled and topical corticosteroids acceptable), investigational products, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry. * Have donated blood or blood products within 28 days before study vaccination, plan to donate blood at any time during the study and up to 28 days after the last blood draw. * Allergy to penicillin, cephalosporins or ciprofloxacin or to lidocaine or any component of 4C-MenB vaccine or control vaccines (flu, Influenza vaccine (FLULAVALTM) and Td, TDVAXTM), including latex (confirmed delayed contact hypersensitivity to latex is not exclusionary) * Treatment with medications that are contraindicated with cefixime, ceftriaxone or ciprofloxacin and that cannot be withheld for the single doses given in this study * Serum creatinine level \> 1.1X upper limit of normal (ULN) and deemed clinically significant by the study physician * Serum ALT level \> 1.25X ULN and deemed clinically significant by the study physician * WBC count \< 2.5 or \> 15.0 x109/L and deemed clinically significant by the study physician * Absolute neutrophil count (ANC) \< 1.0 x 109/L and deemed clinically significant by the study physician * Hemoglobin level \< 11.0 g/dL or above ULN and deemed clinically significant by the study physician * Urinalysis: Qualitative protein level ≥ 1+ or Red blood cell (RBC) count≥ 6/hpf * Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial. Medications not permitted with cefixime or ceftriaxone: Warfarin Probenecid Aspirin Diuretics such as furosemide Aminoglycoside antibiotics Chloramphenicol Medications not permitted with ciprofloxacin: Tizanidine Theophylline Warfarin Glyburide Cyclosporine Probenecid Phenytoin Methotrexate Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc Caffeine-containing medications Sucralfate or didanosine chewable or buffered tablets
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical and Translational Research Center (CTRC) at University of North Carolina (UNC) Hospitals and/or at UNC Global Clinical Research North
Chapel Hill, North Carolina, 27599-7215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.