Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
Gonococcal Infection
About this trial
This is an interventional prevention trial for Gonococcal Infection focused on measuring Bexsero, Gonococcal infection, Meningococcal Group B Vaccine rMenB+OMV NZ, Observer-blind, Phase 2, Placebo-controlled study
Eligibility Criteria
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**.
*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 Criteria:
- 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, latex, 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.
Sites / Locations
- University of Alabama at Birmingham School of Medicine - Infectious DiseaseRecruiting
- UCLA Clinical AIDS Research and Education (CARE) CenterRecruiting
- SFDPH Bridge HIV Center
- Emory University Hospital Midtown - Emory Clinic Infectious DiseasesRecruiting
- Cook County Health and Hospitals System - Ruth M Rothstein CORE Center
- Indiana University School of Medicine - Infectious Diseases
- LSU - CrescentCare Sexual Health CenterRecruiting
- Walter Reed National Military Medical CenterRecruiting
- Harlem Prevention Center, Columbia University, Mailman School of Public Health
- University of Pennsylvania HIV/AIDS Prevention Research Division
- The Thai Red Cross AIDS Research CentreRecruiting
- Armed Forces Research Institute of Medical Sciences - Royal Thai Army Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group 1
Group 2
Bexsero vaccine will be administered as an intramuscular injection in 1 mL single-dose prefilled syringe in two doses with a two-month apart (at enrollment/Visit 1 and Visit 3). N=1100.
Placebo will be administered as an intramuscular injection in single-dose prefilled syringe in two doses with a two-month apart (at enrollment/Visit 1 and Visit 3). N=1100.