Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Gonococcal Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 ag...
Detailed Description
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 ag...
Eligibility Criteria
Inclusion
- 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\*\*.
- \*Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopausal (no menses for at least 12 months);
- \*\*Note: Although contraceptive methods are not mandated since Bexsero is a marketed product and will be used according to the label, it is anticipated that contraceptive counselling will be provided according to local standard of care.
- 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
- 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;\*
- \*Authorized or approved, inactivated COVID-19 vaccines may be given more than 7 days +/- receipt of study product for all study participants.
- Currently receiving immunosuppressive agent or systemic corticosteroid (dose \>/=5 mg/day of prednisone) for \> 14 consecutive days within 90 days prior to enrollment\*;
- \*Topical or inhaled steroids allowed, unless applied to study project injection site.
- Has received antineoplastic, or radiotherapy within 90 days prior to enrollment;
- Has received immunoglobulins and/or any blood products within 180 days prior to enrollment;
- Known or confirmed hypersensitivity to any of the vaccine constituents, medical products, or medical equipment whose use is foreseen in this study;
- HIV-infected participants with CD4 cell count \< 300 cells/mm3 in the last year;
- Has a condition which in the opinion of the investigator is not suitable for intramuscular vaccination, blood draws, or participation in the trial;
- Participant is breastfeeding.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2026
Estimated Enrollment :
2606 Patients enrolled
Trial Details
Trial ID
NCT04350138
Start Date
December 29 2020
End Date
February 26 2026
Last Update
January 2 2026
Active Locations (13)
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1
University of Alabama at Birmingham School of Medicine - Infectious Disease
Birmingham, Alabama, United States, 35294
2
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90035
3
SFDPH Bridge HIV Center
San Francisco, California, United States, 94102
4
Emory University School of Medicine - The Ponce de Leon Center
Atlanta, Georgia, United States, 30303