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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 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 65 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05294588
The ClinicalTrials.gov registry entry for NCT05294588 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ciprofloxacin is the first listed.
NCT05294588 reports 0 study locations.
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.
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