Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination (NCT04722003) | Clinical Trial Compass
CompletedPhase 2
Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
United States52 participantsStarted 2021-11-01
Plain-language 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.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be aged 18-49 years old (inclusive) at the time of vaccination.
. Must be able to provide written informed consent.
. Must have a body mass index (BMI) \>/= 18.5 and \< 35.0 kg/m2
. Must be in good health based on physical examination, vital signs\*, medical history, safety labs\*\* (as applicable to the rectal biopsy and no biopsy cohorts) and the investigator's clinical judgment.
. For female subjects only: If a female participant is of childbearing potential\*, she must use contraception\*\* from 30 days before study product administration through the end of study participation.
. Must be available and willing to participate for the duration of this trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Timeframe: Day 1 through Day 181
2
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Timeframe: Day 1 through day 181
Trial details
NCT IDNCT04722003
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Willing to provide mucosal samples: vaginal secretions for women and oropharyngeal and rectal secretions for men and women.
. For the rectal biopsy cohort only, willing to provide rectal biopsies.
Exclusion criteria
. Has ever been diagnosed with meningococcal infection or gonococcal infection at any anatomic site.
. Has ever received any serogroup B meningococcal vaccine.
. Any positive test result for STI (including Neisseria gonorrhoeae (GC) Chlamydia trachomatis (CT), Rapid Plasma Reagin (RPR) and Human Immunodeficiency Virus (HIV)) at screening\*.
. Any history of Chlamydia trachomatis or syphilis infection at any body site in the preceding 12 months
. Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products.
. Has severe allergy or anaphylaxis to latex.
. Has an acute illness or temperature \>/= 38.0 degrees Celsius on Day 1\*.
. Has a history of a bleeding disorder, or is taking chronic anti-coagulant (e.g. warfarin, direct thrombin inhibitors, heparin products, etc.), anti-platelet, or non-steroidal anti-inflammatory drugs (NSAID) therapy.