Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection

NCT04350138 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 19-0004
• Study Type: interventional
• Target: 2,606
• Locations: 3 countries
• Sites: 13

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 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.

Conditions

Gonococcal Infection

Keywords

Bexsero; Gonococcal infection; Meningococcal Group B Vaccine rMenB+OMV NZ; Observer-blind; Phase 2; Placebo-controlled study

Outcome Measures

Primary Outcomes (1)

• Number of participants diagnosed with urogenital or anorectal gonococcal infection post second vaccination

  Confirmed by Nucleic Acid Amplification Test (NAAT).

  Day 91 to Day 451

Secondary Outcomes (5)

• Number of participants diagnosed with urogenital, anorectal, or pharyngeal gonococcal infection post second vaccination

  Day 91 to Day 451

• Proportion of participants that experience at least one adverse event (AE) that results in withdrawal from study

  Day 1 to Day 451

• Proportion of participants that experience at least one adverse event of special interest (AESI)

  Day 1 to Day 451

• Proportion of participants that experience at least one serious adverse event (SAE)

  Day 1 to Day 451

• Proportion of participants with at least one medically attended adverse event (MAAE)

  Day 1 to Day 451

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Meningococcal Group B Vaccine BIOLOGICAL

A combination vaccine consisting of rMenB and OMV NZ.

Group 1

Placebo OTHER

150mM sodium chloride (0.9% saline solution).

Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (13)

University of Alabama at Birmingham School of Medicine - Infectious Disease

Birmingham, Alabama, 35294, United States

Location

UCLA Clinical AIDS Research and Education (CARE) Center

Los Angeles, California, 90035, United States

Location

SFDPH Bridge HIV Center

San Francisco, California, 94102, United States

Location

Emory University School of Medicine - The Ponce de Leon Center

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown - Emory Clinic Infectious Diseases

Atlanta, Georgia, 30308, United States

Location

University of Illinois at Chicago College of Medicine - Division of Infectious Diseases

Chicago, Illinois, 60612, United States

Location

LSU - CrescentCare Sexual Health Center

New Orleans, Louisiana, 70119, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Harlem Prevention Center, Columbia University, Mailman School of Public Health

New York, New York, 10027, United States

Location

University of Pennsylvania HIV/AIDS Prevention Research Division

Philadelphia, Pennsylvania, 19104, United States

Location

Malawi Clinical Research Site, Lilongwe

Lilongwe, Central Region, Malawi

Location

The Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

Armed Forces Research Institute of Medical Sciences - Royal Thai Army Clinical Research Center

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Gonorrhea

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 16, 2020
• Study Start: December 29, 2020
• Primary Completion: February 18, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2025-07-18

Locations

MA (1); TH (2); US (10)