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NCT05294588 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT05294588: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT05294588 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05294588, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Ciprofloxacin
- DRUG Ceftriaxone
- BIOLOGICAL Meningococcal Group B Vaccine
- DRUG Cefixime
- BIOLOGICAL Neisseria gonorrhoeae strain FA1090
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2022-04-18 |
| Est. Completion | 2026-02-05 |
| Phase | Phase 2 |
What the finished NCT05294588 record still lists
NCT05294588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 5 interventions - of which Ciprofloxacin is the first listed.
NCT05294588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05294588 about?
NCT05294588 is a clinical study titled "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 ...
What is the current status of trial NCT05294588?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2022-04-18. Estimated completion is 2026-02-05.
What interventions are being tested in trial NCT05294588?
The interventions under investigation include: Ciprofloxacin (DRUG), Ceftriaxone (DRUG), Meningococcal Group B Vaccine (BIOLOGICAL), Cefixime (DRUG), Neisseria gonorrhoeae strain FA1090 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05294588?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05294588's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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