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NCT04722003 · ClinicalTrials.gov registry record · Phase 2
Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT04722003: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04722003 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04722003, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal immunogenicity of the multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero (R)) (group 1, 40 subjects) against Neisseria gonorrhoeae, using a placebo vaccine (normal saline) as a comparator (group 2, 10 subjects). There will be approximately 50 participants, ages 18-49, both male and non-pregnant female subjects, enrolled at 1 site in the US. The goal will be to ensure adequate representation of subjects by sex in both treatment groups. The enrollment will be stratified by both sex and treatment arm. During enrollment of the "biopsy cohort" male and non-pregnant female subjects will be randomized 4:1 to either 4CMenB or placebo, up to a maximum of 10 male and 10 non-pregnant female subjects. Group 1 (approximate N=40) will receive two doses of 4CMenB on Day 1 and Day 29. Group 2 (approximate N=10) will receive two placebo injections on Day 1 and Day 29. Both groups will receive a single-dose prefilled syringe that is administered intramuscularly (0.5-mililiter each). The duration of each subject's participation is approximately 8 months, from recruitment through the last study visit, and the length of the study is estimated for 14 months. The primary objective is to characterize the rectal mucosal Immunoglobulin G IgG antibody response to Neisseria gonorrhoeae (GC) elicited by the 4CMenB vaccine as compared with the placebo vaccine (normal saline) in healthy adult subjects.
Primary Outcome
Rectal mucosal IgG concentrations (geometric mean titers, GMT) against GC OMV antigen Ng1291 by ELISA at Day 1, 29, 43, 57, and 181 in each treatment group
Interventions
- OTHER Placebo
- BIOLOGICAL Meningococcal Group B Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-10-02 |
| Phase | Phase 2 |
What the finished NCT04722003 record still lists
NCT04722003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04722003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04722003 about?
NCT04722003 is a clinical study titled "Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination". This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal immunogenicity of the multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero (R)) (group 1, 40 subjects) against Neisseria gonorrhoeae, using a placebo vaccine (normal saline) as a comparator (group 2, 10 su...
What is the current status of trial NCT04722003?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2021-11-01. Estimated completion is 2023-10-02.
What interventions are being tested in trial NCT04722003?
The interventions under investigation include: Placebo (OTHER), Meningococcal Group B Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04722003?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04722003's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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