Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gono… (NCT04350138) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
United States, Malawi, Thailand2,606 participantsStarted 2020-12-29
Plain-language summary
This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 primary endpoints in the Per Protocol Population. Data will be collected in an observer-blind manner. Study product recipients and study staff responsible for the evaluation of any study endpoint will be unaware of whether Bexsero or placebo were administered. The duration of the study for participants who are enrolled and randomized will be approximately 16 months. Study participation is expected to be completed in approximately 36 months. The primary objective of the study is to demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection.
Who can participate
Age range
18 Years – 50 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
. Participants aged 18 to 50 years of age inclusive on the day of enrollment;
. If female, participant must be of non-childbearing potential\* or has a negative pregnancy test prior to each vaccination\*\*.
. Participant is in good health as determined by past medical history, medication use, and targeted physical examination (including vital signs), in opinion of investigator or their delegate;
. Has provided signed informed consent;
. Willing and likely to comply with the trial procedures;
. Is prepared to grant authorized persons access to the study's medical records.
Exclusion criteria
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
Number of participants diagnosed with urogenital or anorectal gonococcal infection post second vaccination
Timeframe: Day 91 to Day 451
Trial details
NCT IDNCT04350138
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Previous receipt of a Meningococcal Group B vaccine;
. Gonorrhea or chlamydia infection identified by a positive nucleic acid amplification test (NAAT) within 14 days prior to randomization;
. Receipt of antibiotics active against N. gonorrhoeae in the prior 14 days, including oral or parenteral antibiotics;
. Progressive, unstable, or uncontrolled disease including but not limited to cardiac, hepatic, renal, immunological, neurological or psychiatric conditions;
. Use of any investigational drug (with the exception of an authorized or approved COVID-19 vaccine) within 30 days prior to enrollment, or planned/anticipated use during study participation;
. Has received or plans to receive a live vaccine within +/- 30 days, an inactive vaccine within +/- 14 days, or an influenza vaccine within +/- 7 days from receipt of study product;\*
. Currently receiving immunosuppressive agent or systemic corticosteroid (dose \>/=5 mg/day of prednisone) for \> 14 consecutive days within 90 days prior to enrollment\*;
. Has received antineoplastic, or radiotherapy within 90 days prior to enrollment;