Gonococcal InfectionPhase 2NCT04350138
Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
A Phase 2 study testing Meningococcal Group B Vaccine in people with Gonococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gonococcal Infection
- What is being tested?
- Meningococcal Group B Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,606 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 29 Dec 2020to 8 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;*
Show all 15Show fewer
- 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.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States10 sites
Emory University School of Medicine - The Ponce de Leon Center
Atlanta, Georgia, 30303
Emory University Hospital Midtown - Emory Clinic Infectious Diseases
Atlanta, Georgia, 30308
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of Alabama at Birmingham School of Medicine - Infectious Disease
Birmingham, Alabama, 35294
University of Illinois at Chicago College of Medicine - Division of Infectious Diseases
Chicago, Illinois, 60612
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90035
LSU - CrescentCare Sexual Health Center
New Orleans, Louisiana, 70119
Harlem Prevention Center, Columbia University, Mailman School of Public Health
New York, New York, 10027
University of Pennsylvania HIV/AIDS Prevention Research Division
Philadelphia, Pennsylvania, 19104
SFDPH Bridge HIV Center
San Francisco, California, 94102
Thailand2 sites
The Thai Red Cross AIDS Research Centre
Bangkok, 10330
Armed Forces Research Institute of Medical Sciences - Royal Thai Army Clinical Research Center
Bangkok, 10400
About this study
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
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.
Read the 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 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. Participants who consent to screening will have baseline clinical information collected at Visit 0, Screening (Day -14 [Window -45 to -7]). This information will consist of medical history, concomitant medications, physical exam, sexual history, and clinical and laboratory findings. Participants will undergo a physical exam and have blood drawn to establish baseline laboratory values for safety assessment. Urine or a vaginal swab, and a rectal swab will be collected for Nucleic Acid Amplification Test (NAAT) for gonorrhea and chlamydia. A pharyngeal swab will be collected for NAAT testing of gonorrhea. At the enrollment visit, Visit 1, participants who test negative for gonorrhea and who otherwise qualify will be enrolled and randomized in a 1:1 ratio to receive the initial intramuscular (IM) dose of study product. A phone call, Visit 2, will be held approximately 30 days after the initial study product dose was received and will be conducted with all participants to assess for safety events in the interim. At Visit 3, the participant will receive the second dose of study product. Visit 4 will be held 1 month after second dose. At 3-month intervals, through the final study follow-up visit, participants will have clinic study visits, Visit 5 thru Visit 8. The duration of the study for participants who are enrolled and randomized will be approximately 16 months. For those not enrolled, participation could end at their Visit 0, Screening; post Visit 0, Screening based on NAAT test results; or Visit 1, Enrollment. 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. The secondary objectives are to estimate efficacy of Bexsero in prevention of overall gonococcal infection and by anatomical site (urogenital, anorectal or pharyngeal) and to assess safety of Bexsero.
- Conditions
- Gonococcal Infection
- Being tested
- Meningococcal Group B Vaccine, Placebo
- Keywords
- Bexsero, Gonococcal infection, Meningococcal Group B Vaccine rMenB+OMV NZ, Observer-blind, Phase 2, Placebo-controlled study
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Group B VaccineBiological
A combination vaccine consisting of rMenB and OMV NZ.
PlaceboOther
150mM sodium chloride (0.9% saline solution).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants diagnosed with urogenital or anorectal gonococcal infection post second vaccination
Confirmed by Nucleic Acid Amplification Test (NAAT).
Measured: Day 91 to Day 451
Secondary outcomes (5)
Number of participants diagnosed with urogenital, anorectal, or pharyngeal gonococcal infection post second vaccination
Confirmed by Nucleic Acid Amplification Test (NAAT).
Measured: Day 91 to Day 451
Proportion of participants that experience at least one adverse event (AE) that results in withdrawal from study
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.
Measured: Day 1 to Day 451
Proportion of participants that experience at least one adverse event of special interest (AESI)
Adverse Event of Special Interest (AESI) are specific to the protocol: Arthritis, Potential immune-mediated diseases (pIMD).
Measured: Day 1 to Day 451
Proportion of participants that experience at least one serious adverse event (SAE)
Measured: Day 1 to Day 451
Proportion of participants with at least one medically attended adverse event (MAAE)
Measured: Day 1 to Day 451
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start29 Dec 2020
- Primary completion18 Feb 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonococcal InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,606 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350138
- Sponsor's protocol ID
- 19-0004
- Status last verified
- 30 Jan 2026
- First submitted
- 15 Apr 2020
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04350138
- Acronym / sponsor ID
- 19-0004
- Conditions
- Gonococcal Infection
- Keywords
- Bexsero, Gonococcal infection, Meningococcal Group B Vaccine rMenB+OMV NZ, Observer-blind, Phase 2, Placebo-controlled study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,606 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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. Participants who consent to screening will have baseline clinical information collected at Visit 0, Screening (Day -14 [Window -45 to -7]). This information will consist of medical history, concomitant medications, physical exam, sexual history, and clinical and laboratory findings. Participants will undergo a physical exam and have blood drawn to establish baseline laboratory values for safety assessment. Urine or a vaginal swab, and a rectal swab will be collected for Nucleic Acid Amplification Test (NAAT) for gonorrhea and chlamydia. A pharyngeal swab will be collected for NAAT testing of gonorrhea. At the enrollment visit, Visit 1, participants who test negative for gonorrhea and who otherwise qualify will be enrolled and randomized in a 1:1 ratio to receive the initial intramuscular (IM) dose of study product. A phone call, Visit 2, will be held approximately 30 days after the initial study product dose was received and will be conducted with all participants to assess for safety events in the interim. At Visit 3, the participant will receive the second dose of study product. Visit 4 will be held 1 month after second dose. At 3-month intervals, through the final study follow-up visit, participants will have clinic study visits, Visit 5 thru Visit 8. The duration of the study for participants who are enrolled and randomized will be approximately 16 months. For those not enrolled, participation could end at their Visit 0, Screening; post Visit 0, Screening based on NAAT test results; or Visit 1, Enrollment. 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. The secondary objectives are to estimate efficacy of Bexsero in prevention of overall gonococcal infection and by anatomical site (urogenital, anorectal or pharyngeal) and to assess safety of Bexsero.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Meningococcal Group B VaccineBexsero 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. |
| Group 2 | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningococcal Group B VaccineA combination vaccine consisting of rMenB and OMV NZ. | Biological | Group 1 |
| Placebo150mM sodium chloride (0.9% saline solution). | Other | Group 2 |
Primary outcome
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).
5 secondary outcomes
Number of participants diagnosed with urogenital, anorectal, or pharyngeal gonococcal infection post second vaccination
Time frame: Day 91 to Day 451
Proportion of participants that experience at least one adverse event (AE) that results in withdrawal from study
Time frame: Day 1 to Day 451
Proportion of participants that experience at least one adverse event of special interest (AESI)
Time frame: Day 1 to Day 451
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Related trials for Gonococcal Infection
Active, not recruitingPhase 4
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Gonorrhea Male, Chlamydia (Male)
Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
HIV, Syphilis
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
RecruitingPhase 4
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
Gonorrhea, Chlamydia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meningococcal Group B Vaccine in people with Gonococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Thailand, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants diagnosed with urogenital or anorectal gonococcal infection post second vaccination (time frame: Day 91 to Day 451). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.