Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04350138|
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : March 24, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Gonococcal Infection||Biological: Meningococcal Group B Vaccine Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection|
|Actual Study Start Date :||December 29, 2020|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||September 30, 2023|
Experimental: Group 1
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.
Biological: Meningococcal Group B Vaccine
A combination vaccine consisting of rMenB and OMV NZ.
Placebo Comparator: Group 2
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.
150mM sodium chloride (0.9% saline solution).
- Number of participants diagnosed with urogenital or anorectal gonococcal infection post second vaccination [ Time Frame: Day 91 to Day 451 ]Confirmed by Nucleic Acid Amplification Test (NAAT).
- Number of participants diagnosed with urogenital, anorectal, or pharyngeal gonococcal infection post second vaccination [ Time Frame: Day 91 to Day 451 ]Confirmed by Nucleic Acid Amplification Test (NAAT).
- Proportion of participants that experience at least one adverse event (AE) that results in withdrawal from study [ Time Frame: Day 1 to Day 451 ]Disease or medical condition, or new clinical finding(s) for which continued participation, in the opinion of the investigator might compromise the safety of the participant, interfere with the participant's successful completion of this study, or interfere with the evaluation of study endpoints.
- Proportion of participants that experience at least one adverse event of special interest (AESI) [ Time Frame: Day 1 to Day 451 ]Adverse Event of Special Interest (AESI) are specific to the protocol: Arthritis, Potential immune-mediated diseases (pIMD).
- Proportion of participants that experience at least one serious adverse event (SAE) [ Time Frame: Day 1 to Day 451 ]
- Proportion of participants with at least one medically attended adverse event (MAAE) [ Time Frame: Day 1 to Day 451 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350138
|Contact: Jeanne M. Marrazzoemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham School of Medicine - Infectious Disease||Recruiting|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|UCLA Clinical AIDS Research and Education (CARE) Center||Recruiting|
|Los Angeles, California, United States, 90035|
|SFDPH Bridge HIV Center||Not yet recruiting|
|San Francisco, California, United States, 94102|
|United States, Georgia|
|Emory University Hospital Midtown - Emory Clinic Infectious Diseases||Recruiting|
|Atlanta, Georgia, United States, 30308|
|United States, Illinois|
|Cook County Health and Hospitals System - Ruth M Rothstein CORE Center||Not yet recruiting|
|Chicago, Illinois, United States, 60612|
|United States, Indiana|
|Indiana University School of Medicine - Infectious Diseases||Not yet recruiting|
|Indianapolis, Indiana, United States, 46202|
|United States, Louisiana|
|LSU - CrescentCare Sexual Health Center||Recruiting|
|New Orleans, Louisiana, United States, 70119|
|United States, Maryland|
|Walter Reed National Military Medical Center||Recruiting|
|Bethesda, Maryland, United States, 20889|
|United States, New York|
|Harlem Prevention Center, Columbia University, Mailman School of Public Health||Not yet recruiting|
|New York, New York, United States, 10027|
|United States, Pennsylvania|
|University of Pennsylvania HIV/AIDS Prevention Research Division||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|The Thai Red Cross AIDS Research Centre||Recruiting|
|Bangkok, Thailand, 10330|
|Armed Forces Research Institute of Medical Sciences - Royal Thai Army Clinical Research Center||Recruiting|
|Bangkok, Thailand, 10400|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||April 16, 2020 Key Record Dates|
|Last Update Posted:||March 24, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Meningococcal Group B Vaccine rMenB+OMV NZ
Gram-Negative Bacterial Infections
Bacterial Infections and Mycoses
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases