Gonorrhea MalePhase 2NCT05294588
Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae
A Phase 2 study testing Cefixime, Ceftriaxone and Ciprofloxacin in people with Gonorrhea Male, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gonorrhea Male
- What is being tested?
- Cefixime, Ceftriaxone and Ciprofloxacin
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 5 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
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
About this study
Official title: 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.
Read the detailed description
The study is a single-site, double-blind randomized controlled trial to test whether vaccination with 4C-MenB, BEXSERO™ (approved for protection against invasive disease with group B Neisseria meningitidis), according to the FDA-approved schedule , provides protection from urethral infection with Neisseria gonorrhoeae in the controlled human male gonococcal infection model. The study will be conducted in 3 phases: 1) initial vaccination phase, 2) Neisseria gonorrhoeae challenge phase, and 3) post-challenge vaccination phase.
The study intervention is vaccination with two doses of BEXSERO™ and two commercially available FDA-approved vaccines that do not have relevance to Neisseria gonorrhoeae: quadrivalent influenza (FLULAVAL™) and tetanus/diphtheria (TDVAX™). At enrollment, participants are randomized in a 1:1 ratio to the control vaccine arm or the experimental vaccine arm. All participants receive two immunizations prior to the bacterial challenge phase and two immunizations in the post-challenge phase. Individuals assigned to the experimental arm receive two doses of BEXSERO™ prior to Neisseria gonorrhoeae challenge and control vaccines in the post-challenge vaccination phase. Participants assigned to the control arm receive FLULAVAL™ and TDVAX™ prior to challenge and BEXSERO™ in the post-challenge vaccination phase. Primary and secondary outcomes are determined following bacterial challenge. This study design provides clinical equipoise, because all participants receive the known benefits associated with administration of BEXSERO™ for protection against meningococcal disease.
For bacterial challenge, all participants receive a suspension containing 10^6 colony-forming units of Neisseria gonorrhoeae strain FA1090 delivered to the anterior urethra. This dose has been shown to produce symptomatic gonococcal urethritis in 80-90% of unvaccinated, exposed participants within 5 days after bacterial inoculation. Participants are followed with daily visits to assess for development of urethritis and presence of Neisseria gonorrhoeae in their urine. Participants receive 100% effective antibiotic treatment when (1) requested by the participant regardless of signs, symptoms or positive cultures, (2) urethral discharge is observed by the examining clinician or reported by the participant, or (3) 10 days after urethral inoculation with bacterial product, regardless of infection status.
- Conditions
- Gonorrhea Male
- Being tested
- Cefixime, Ceftriaxone, Ciprofloxacin, Neisseria gonorrhoeae strain FA1090, Meningococcal Group B Vaccine
- Keywords
- 4CMenB, Bexsero, vaccine, controlled human infection model, Neisseria gonorrhoeae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefiximeDrug
Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of clinically apparent urethritis or on the 10th study day after inoculation.
CeftriaxoneDrug
Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of clinically apparent urethritis or on the 10th study day after inoculation.
CiprofloxacinDrug
Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the subject has a positive N. gonorrhoeae test within 1 week post initial antibiotic treatment
Neisseria gonorrhoeae strain FA1090Biological
0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
Meningococcal Group B VaccineBiological
Also called Bexsero, 4-component Neisseria meningitidis group B vaccine, 4CMenB
All participants will receive 2 doses of the 4CMenB vaccine, 0.5 mL intramuscularly
Influenza VaccineBiological
Also called Flulaval
All participants will receive the quadrivalent influenza vaccine, 0.5 mL intramuscularly.
Tetanus-diptheria VaccineBiological
Also called TDVAX
All participants will receive the Td vaccine, 0.5 mL intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | All participants receive two immunizations prior to the bacterial challenge phase and two immunizations after the challenge phase. Individuals assigned to the experimental arm receive the recommended two doses of BEXSERO™ prior to bacterial challenge and control vaccines (FLULAVAL™ and TDVAX™) in the post-challenge vaccination phase.
For bacterial challenge, all participants receive a suspension containing 10^6 colony-forming units of N. gonorrhoeae strain FA1090 delivered to the anterior urethra. Participants receive 100% effective antibiotic treatment for N. gonorrhoeae strain FA1090 infection when (1) requested by the participant regardless of signs, symptoms or positive cultures, (2) urethral discharge is observed by the examining clinician or reported by the participant, or (3) 10 days afterurethral inoculation with bacterial product, regardless of infection status. Receives: Drug: Cefixime; Drug: Ceftriaxone; Drug: Ciprofloxacin; Biological: Neisseria gonorrhoeae strain FA1090; Biological: Meningococcal Group B Vaccine; Biological: Influenza Vaccine; Biological: Tetanus-diptheria Vaccine |
| Control arm | Other | All participants receive two immunizations prior to the bacterial challenge phase and two immunizations after the challenge phase. Individuals assigned to the control arm receive control vaccines that have no relevance to N. gonorrhoeae infection (FLULAVAL™ and TDVAX™) prior to bacterial challenge and then receive two doses of BEXSERO™ in the post-challenge vaccination phase.
For bacterial challenge, all participants receive a suspension containing 10^6 colony-forming units of N. gonorrhoeae strain FA1090 delivered to the anterior urethra. Participants receive 100% effective antibiotic treatment for N. gonorrhoeae strain FA1090 infection when (1) requested by the participant regardless of signs, symptoms or positive cultures, (2) urethral discharge is observed by the examining clinician or reported by the participant, or (3) 10 days afterurethral inoculation with bacterial product, regardless of infection status. Receives: Drug: Cefixime; Drug: Ceftriaxone; Drug: Ciprofloxacin; Biological: Neisseria gonorrhoeae strain FA1090; Biological: Meningococcal Group B Vaccine; Biological: Influenza Vaccine; Biological: Tetanus-diptheria Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectivity of N. gonorrhoeae inoculum
Infectivity is defined as the proportion of participants positive for N. gonorrhoeae by N. gonorrhoeae Nucleic acid amplification tests (NAAT) or urine culture or swab culture on the post-inoculation antibiotic treatment day in each study group (control and experimental).
Measured: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)
Secondary outcomes (3)
Proportion of participants that develop macroscopic urethritis
The proportion of participants with protocol defined macroscopic urethritis on the post-inoculation antibiotic treatment day in each study group (control and experimental).
Measured: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)
Proportion of participants that develop symptomatic microscopic urethritis
The proportion of participants with protocol defined symptomatic microscopic urethritis on the post-inoculation antibiotic treatment day in each study group (control and experimental).
Measured: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)
Time to develop macroscopic urethritis
The time to develop macroscopic urethritis is defined as the number of days after urethral inoculation with N. gonorrhoeae to the day that protocol defined macroscopic urethritis triggers antibiotic treatment will determined for each study group (control and experimental)
Measured: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start18 Apr 2022
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gonorrhea MaleStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study intervention is vaccination with two doses of BEXSERO™and with two commercially available FDA-approved vaccines that do not have relevance to Neisseria gonorrhoeae: quadrivalent influenza (FLULAVAL™) and tetanus/diphtheria (TDVAX™). At enrollment, participants are randomized in a 1:1 ratio to the control vaccine arm or the experimental vaccine arm. Participants assigned to the control arm of the study receive immunization with control vaccinations prior to Neisseria gonorrhoeae challenge and with BEXSERO™after Neisseria gonorrhoeae challenge. Participants assigned to the experimental arm of the study receive immunization with BEXSERO™ prior to Neisseria gonorrhoeae challenge and with after control vaccinations Neisseria gonorrhoeae challenge.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph A Duncan, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294588
- Sponsor's protocol ID
- 21-0498
- Other IDs
- DMID 21-0018, U01AI162457-01
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator/researcher who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Waltmann A, Kronk C, Lapple D, Motley MP, Lin FC, Sena AC, Hobbs MM, Duncan JA. 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. BMJ Open. 2026 Apr 28;16(4):e115296. doi: 10.1136/bmjopen-2025-115296.
PubMed 42049314Firth C, Emary K, Stuart A, Browne R, Williamson M, Francis E, Vanderslott S, Hodgson SH. Acceptability of the gonorrhoea human challenge model to accelerate vaccine development in UK men. Vaccine. 2025 Apr 30;54:127013. doi: 10.1016/j.vaccine.2025.127013. Epub 2025 Mar 13.
PubMed 40086037
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Division of Microbiology and Infectious Diseases, (DMID) 21-0018: Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae
- ClinicalTrials.gov ID
- NCT05294588
- Acronym / sponsor ID
- 21-0498
- Conditions
- Gonorrhea Male
- Keywords
- 4CMenB, Bexsero, vaccine, controlled human infection model, Neisseria gonorrhoeae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a single-site, double-blind randomized controlled trial to test whether vaccination with 4C-MenB, BEXSERO™ (approved for protection against invasive disease with group B Neisseria meningitidis), according to the FDA-approved schedule , provides protection from urethral infection with Neisseria gonorrhoeae in the controlled human male gonococcal infection model. The study will be conducted in 3 phases: 1) initial vaccination phase, 2) Neisseria gonorrhoeae challenge phase, and 3) post-challenge vaccination phase.
The study intervention is vaccination with two doses of BEXSERO™ and two commercially available FDA-approved vaccines that do not have relevance to Neisseria gonorrhoeae: quadrivalent influenza (FLULAVAL™) and tetanus/diphtheria (TDVAX™). At enrollment, participants are randomized in a 1:1 ratio to the control vaccine arm or the experimental vaccine arm. All participants receive two immunizations prior to the bacterial challenge phase and two immunizations in the post-challenge phase. Individuals assigned to the experimental arm receive two doses of BEXSERO™ prior to Neisseria gonorrhoeae challenge and control vaccines in the post-challenge vaccination phase. Participants assigned to the control arm receive FLULAVAL™ and TDVAX™ prior to challenge and BEXSERO™ in the post-challenge vaccination phase. Primary and secondary outcomes are determined following bacterial challenge. This study design provides clinical equipoise, because all participants receive the known benefits associated with administration of BEXSERO™ for protection against meningococcal disease.
For bacterial challenge, all participants receive a suspension containing 10^6 colony-forming units of Neisseria gonorrhoeae strain FA1090 delivered to the anterior urethra. This dose has been shown to produce symptomatic gonococcal urethritis in 80-90% of unvaccinated, exposed participants within 5 days after bacterial inoculation. Participants are followed with daily visits to assess for development of urethritis and presence of Neisseria gonorrhoeae in their urine. Participants receive 100% effective antibiotic treatment when (1) requested by the participant regardless of signs, symptoms or positive cultures, (2) urethral discharge is observed by the examining clinician or reported by the participant, or (3) 10 days after urethral inoculation with bacterial product, regardless of infection status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The study intervention is vaccination with two doses of BEXSERO™and with two commercially available FDA-approved vaccines that do not have relevance to Neisseria gonorrhoeae: quadrivalent influenza (FLULAVAL™) and tetanus/diphtheria (TDVAX™). At enrollment, participants are randomized in a 1:1 ratio to the control vaccine arm or the experimental vaccine arm. Participants assigned to the control arm of the study receive immunization with control vaccinations prior to Neisseria gonorrhoeae challenge and with BEXSERO™after Neisseria gonorrhoeae challenge. Participants assigned to the experimental arm of the study receive immunization with BEXSERO™ prior to Neisseria gonorrhoeae challenge and with after control vaccinations Neisseria gonorrhoeae challenge.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Cefixime, Drug: Ceftriaxone, Drug: Ciprofloxacin, Biological: Neisseria gonorrhoeae strain FA1090, Biological: Meningococcal Group B Vaccine, Biological: Influenza Vaccine, Biological: Tetanus-diptheria VaccineAll participants receive two immunizations prior to the bacterial challenge phase and two immunizations after the challenge phase. Individuals assigned to the experimental arm receive the recommended two doses of BEXSERO™ prior to bacterial challenge and control vaccines (FLULAVAL™ and TDVAX™) in the post-challenge vaccination phase. For bacterial challenge, all participants receive a suspension containing 10^6 colony-forming units of N. gonorrhoeae strain FA1090 delivered to the anterior urethra. Participants receive 100% effective antibiotic treatment for N. gonorrhoeae strain FA1090 infection when (1) requested by the participant regardless of signs, symptoms or positive cultures, (2) urethral discharge is observed by the examining clinician or reported by the participant, or (3) 10 days afterurethral inoculation with bacterial product, regardless of infection status. |
| Control arm | Other | Drug: Cefixime, Drug: Ceftriaxone, Drug: Ciprofloxacin, Biological: Neisseria gonorrhoeae strain FA1090, Biological: Meningococcal Group B Vaccine, Biological: Influenza Vaccine, Biological: Tetanus-diptheria VaccineAll participants receive two immunizations prior to the bacterial challenge phase and two immunizations after the challenge phase. Individuals assigned to the control arm receive control vaccines that have no relevance to N. gonorrhoeae infection (FLULAVAL™ and TDVAX™) prior to bacterial challenge and then receive two doses of BEXSERO™ in the post-challenge vaccination phase. For bacterial challenge, all participants receive a suspension containing 10^6 colony-forming units of N. gonorrhoeae strain FA1090 delivered to the anterior urethra. Participants receive 100% effective antibiotic treatment for N. gonorrhoeae strain FA1090 infection when (1) requested by the participant regardless of signs, symptoms or positive cultures, (2) urethral discharge is observed by the examining clinician or reported by the participant, or (3) 10 days afterurethral inoculation with bacterial product, regardless of infection status. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefiximeMandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of clinically apparent urethritis or on the 10th study day after inoculation. | Drug | Control arm, Experimental arm |
| CeftriaxoneMandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of clinically apparent urethritis or on the 10th study day after inoculation. | Drug | Control arm, Experimental arm |
| CiprofloxacinMandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the subject has a positive N. gonorrhoeae test within 1 week post initial antibiotic treatment | Drug | Control arm, Experimental arm |
| Neisseria gonorrhoeae strain FA10900.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter. | Biological | Control arm, Experimental arm |
| Meningococcal Group B VaccineAlso: Bexsero, 4-component Neisseria meningitidis group B vaccine, 4CMenBAll participants will receive 2 doses of the 4CMenB vaccine, 0.5 mL intramuscularly | Biological | Control arm, Experimental arm |
| Influenza VaccineAlso: FlulavalAll participants will receive the quadrivalent influenza vaccine, 0.5 mL intramuscularly. | Biological | Control arm, Experimental arm |
| Tetanus-diptheria VaccineAlso: TDVAXAll participants will receive the Td vaccine, 0.5 mL intramuscularly. | Biological | Control arm, Experimental arm |
Primary outcome
Infectivity of N. gonorrhoeae inoculum
Time frame: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)
Infectivity is defined as the proportion of participants positive for N. gonorrhoeae by N. gonorrhoeae Nucleic acid amplification tests (NAAT) or urine culture or swab culture on the post-inoculation antibiotic treatment day in each study group (control and experimental).
3 secondary outcomes
Proportion of participants that develop macroscopic urethritis
Time frame: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)
Proportion of participants that develop symptomatic microscopic urethritis
Time frame: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)
Time to develop macroscopic urethritis
Time frame: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Derived from this study: PubMed 42049314Waltmann A, Kronk C, Lapple D, Motley MP, Lin FC, Sena AC, Hobbs MM, Duncan JA. 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. BMJ Open. 2026 Apr 28;16(4):e115296. doi: 10.1136/bmjopen-2025-115296.
- Derived from this study: PubMed 40086037Firth C, Emary K, Stuart A, Browne R, Williamson M, Francis E, Vanderslott S, Hodgson SH. Acceptability of the gonorrhoea human challenge model to accelerate vaccine development in UK men. Vaccine. 2025 Apr 30;54:127013. doi: 10.1016/j.vaccine.2025.127013. Epub 2025 Mar 13.
- Individual participant dataSharing planned: Yes. De-identified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator/researcher who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Duncan, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefixime, Ceftriaxone and Ciprofloxacin in people with Gonorrhea Male, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectivity of N. gonorrhoeae inoculum (time frame: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294588, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.