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Could a meningitis shot stop the spread of gonorrhea?

NCT ID NCT04350138

Prevention Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests whether the meningitis vaccine Bexsero can also prevent gonorrhea, a common sexually transmitted infection. About 2,600 adults aged 18-50 who are at higher risk for gonorrhea will receive either the vaccine or a placebo. Researchers will track how many get infected over 16 months to see if the vaccine offers protection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

2,606 people

The number who actually took part.

Started

Dec 2020

Finished

Jul 2026

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants aged 18 to 50 years of age inclusive on the day of enrollment; 2. 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. 3. 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; 4. Has provided signed informed consent; 5. Willing and likely to comply with the trial procedures; 6. Is prepared to grant authorized persons access to the study's medical records. Exclusion Criteria: 1. Previous receipt of a Meningococcal Group B vaccine; 2. Gonorrhea or chlamydia infection identified by a positive nucleic acid amplification test (NAAT) within 14 days prior to randomization; 3. Receipt of antibiotics active against N. gonorrhoeae in the prior 14 days, including oral or parenteral antibiotics; 4. Progressive, unstable, or uncontrolled disease including but not limited to cardiac, hepatic, renal, immunological, neurological or psychiatric conditions; 5. 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; 6. 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. 7. 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. 8. Has received antineoplastic, or radiotherapy within 90 days prior to enrollment; 9. Has received immunoglobulins and/or any blood products within 180 days prior to enrollment; 10. Known or confirmed hypersensitivity to any of the vaccine constituents, medical products, or medical equipment whose use is foreseen in this study; 11. HIV-infected participants with CD4 cell count \< 300 cells/mm3 in the last year; 12. Has a condition which in the opinion of the investigator is not suitable for intramuscular vaccination, blood draws, or participation in the trial; 13. Participant is breastfeeding.

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Conditions

The condition(s) this trial relates to.

gonorrhea prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gonococcal infection

Contacts and locations

Locations

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

    Bangkok, 10400, Thailand

  • Emory University Hospital Midtown - Emory Clinic Infectious Diseases

    Atlanta, Georgia, 30308, United States

  • Emory University School of Medicine - The Ponce de Leon Center

    Atlanta, Georgia, 30303, United States

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

    New York, New York, 10027, United States

  • LSU - CrescentCare Sexual Health Center

    New Orleans, Louisiana, 70119, United States

  • Malawi Clinical Research Site, Lilongwe

    Lilongwe, Central Region, Malawi

  • SFDPH Bridge HIV Center

    San Francisco, California, 94102, United States

  • The Thai Red Cross AIDS Research Centre

    Bangkok, 10330, Thailand

  • UCLA Clinical AIDS Research and Education (CARE) Center

    Los Angeles, California, 90035, United States

  • University of Alabama at Birmingham School of Medicine - Infectious Disease

    Birmingham, Alabama, 35294, United States

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

    Chicago, Illinois, 60612, United States

  • University of Pennsylvania HIV/AIDS Prevention Research Division

    Philadelphia, Pennsylvania, 19104, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States