Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men (GoGoVax)

March 19, 2025 updated by: Kirby Institute

A Multi-centre Randomised Controlled Trial Evaluating the Efficacy of the Four-component Meningococcal B Vaccine, 4CMenB (Bexsero®), in the Prevention of Neisseria Gonorrhoeae Infection in Gay and Bisexual Men

This is a Phase 3, double-blinded, randomised placebo-controlled, multi-centred trial evaluating the efficacy of the four-component meningococcal B vaccine, 4CMenB (Bexsero®), in the prevention of Neisseria gonorrhoeae infection.The targeted population is 18-50 years-old men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as Gay Bisexual Men+ [GBM+], either HIV-negative and taking pre-exposure prophylaxis [PrEP], or HIV-positive with undetectable viral load <200copies/ml and a cluster of differentiation 4 [CD4] count >350 cells/cmm) who have high N. gonorrhoeae incidence and are recommended by Australian guidelines to have regular, comprehensive sexual health screening. 730 participants will be enrolled and randomised 1:1 and stratified by clinical sites to receive two doses of 4CMenB vaccine or a matching placebo at 0 and 3 months by intramuscular injection. Recruitment is for 12 months and all participants will be follow-up 3-monthly for a period of 2 years. The trial aims to evaluate the efficacy of 4CMenB in the prevention of N. gonorrhoeae infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 3, double-blinded, randomised placebo-controlled, multi-centred trial evaluating the efficacy of the four-component meningococcal B vaccine, 4CMenB (Bexsero®), in the prevention of Neisseria gonorrhoeae infection.The target population for this trial is GBM+, either HIV-negative and on PrEP or HIV-positive, who had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with greater gonorrhoea risk). This population has the highest known gonococcal incidence and are recommended under Australian guidelines to attend clinics 3-monthly for comprehensive sexual health screening, including Nuclei acid amplification test (NAAT)-based screening of urine, and pharyngeal and anal specimens for N. gonorrhoeae infection. 730 participants will be enrolled and randomised 1:1 and stratified by clinical sites to receive two doses of 4CMenB vaccine or a matching placebo at 0 and 3 months by intramuscular injection. Recruitment will occur over a 12-month period and all participants will be followed up 3-monthly over a period of 2 years. Participants, their study clinicians and study researchers assessing the outcomes will be blinded to the treatment arm (vaccine or placebo). Participants will be required to attend approximately 10 study visits. Participants may attend additional visits if they have been diagnosed with gonorrhoea infection (symptomatic or asymptomatic) or have a postitive gonorrhoea NAAT test when they return for test of cure. Potentially eligible individuals will be screened within 14 days of baseline (the visit when the first dose of study treatment is administered). Randomisation can be conducted any time between screening and baseline. Screening, randomisation and baseline can occur on the same day if the required HIV result(s) and drug kit (containing 4CMenB or placebo) are available for a participant in the clinic. At screening, study clinicians will conduct the informed consent process with a participant and the informed consent will be signed by both the study clinician and the participant. Eligibility criteria will be checked and a review of medical history (including vaccination history for 4CMenB, prior known meningococcal disease, recent history of sexually transmitted infections [STIs], history of taking PrEP [for HIV negative individuals] as well as antibiotic use in the last 3 months) will be conducted. Routine blood, urine and swabs will be collected, and urine pregnancy test will be performed in participants with child-bearing potential. Symptoms of urethritis, proctitis, epididymitis, and cervicitis/vaginitis will be documented. At randomisation (which can occur anytime within screening an baseline), participants will be randomised to receive either the 4CMenB vaccine or the placebo. At the baseline visit, research blood specimen and an oral mucosal exudate swab for immune responses testing will be collected before the administration of the first dose of the study treatment. A 10-minute study questionnaire will be completed by the participants. Participants will return to their study site 3 months after the first dose of study treatment to receive the second dose. Prior to the treatment administration, urine pregnancy test (in participants with child-bearing potential) will be conducted. Symptoms of urethritis, proctitis, epididymitis, and cervicitis/vaginitis will be documented. History of antibiotic use in the last 3 months will also be collected. If a participant has tested positive for gonorrhoea infection, routinely collected culture isolates and NAAT samples will be stored in a study research laboratory for phenotypic antimicrobial resistance (AMR) testing and genotyping. Routine blood, urine and swabs will also be collected. Adverse events and serious adverse events (SAEs) will be recorded but only SAEs will be entered into the study electronic data capture system, and reported to the Sponsor in real time. Three-monthly visits will be conducted over a period of 2 years. The study aims to evaluate the efficacy of 4CMenB in the prevention of N. gonorrhoeae infection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
650

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Parramatta, New South Wales, Australia, 2150
        • Western Sydney Sexual Health Centre
      • Sydney, New South Wales, Australia, 2010
        • Taylor Square Private Clinic
      • Sydney, New South Wales, Australia, 2000
        • Sydney Sexual Health Centre
      • Sydney, New South Wales, Australia, 2050
        • RPA Sexual Health
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Gold Coast Sexual Health Service
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Melbourne Sexual Health Centre
      • Melbourne, Victoria, Australia, 3181
        • Prahran Market Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Between 18 to ≤ 50 years of age
  2. Men (cis and trans), trans women and non-binary people who have had sex with at least one man in the last 6 months
  3. Diagnosis of gonorrhoea or infectious syphilis in the last 18 months
  4. Committed not to take doxycycline as prophylaxis for the duration of the trial
  5. Able to understand spoken and written English
  6. Willing and likely to comply with the trial procedures for 2 years
  7. Agree to be contacted via short message service (SMS)/phone/ email by the study team

AND EITHER

  1. HIV-negative (with an HIV negative antibody test within 4 months of screening) and taking HIV PrEP (daily PrEP or on-demand PrEP) within the last 4 months at the time of enrolment or
  2. HIV-positive and on an antiviral regimen, with an undetectable virus level of <200 copies/ml and a CD4 count >350 cells/cmm (to optimise the immune response to vaccine) within 12 months of screening

Exclusion Criteria:

  1. Have a previous history of vaccination for meningococcal B with 4CMenB

  2. Have contraindications to receiving the meningococcal B vaccine which include:

    • Anaphylaxis following a previous dose of any meningococcal vaccine
    • Anaphylaxis following any vaccine component
  3. Are participating in biomedical prevention strategies for bacterial STIs (participation in diagnostic or treatment studies is not an exclusion)
  4. Are taking long-term (> 4 weeks) antibiotic for prophylaxis or treatment for acne, malaria, syphilis or other bacterial condition(s)
  5. Have defects in, or deficiency of, complement components, including factor H, factor D or properdin deficiency
  6. Are taking or will receive complement inhibitors such as eculizumab (a monoclonal antibody directed against complement component C5) or ravulizumab
  7. Have functional or anatomical asplenia, including sickle cell disease or other haemoglobinopathies, and congenital or acquired asplenia
  8. Have had a haematopoietic stem cell transplant
  9. Have any major unstable medical condition or therapy that may cause immune compromise (e.g. chemotherapy, radiation, corticosteroids [prednisone >5mg/day] within 14 days prior to screening)
  10. Documented allergy to latex and/or kanamycin
  11. Have prior known meningococcal disease
  12. Positive pregnancy test at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment arm A - 4CMenB vaccine
4CMenB vaccine will be administered as an intramuscular injection in 0.5 ml single-dose pre-filled syringe in two doses with 3-month apart (at Baseline and Month 3 visit).
Biological: 4CMenB vaccine
A four-component meningococcal B vaccine
Other Names:
  • Bexsero®
Placebo Comparator: Treatment arm B - placebo
Placebo will be administered as an intramuscular injection in 0.5 ml single dose pre-filled syringe in two doses with 3-month apart (at Baseline and Month 3 visit).
Other: Placebo
0.5 ml of 150 mmol sodium chloride (0.9% saline solution)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To measure whether the 4CMenB vaccine, when administered in a 2-dose regimen at 0 and 3 months, changes the incidence of the first episode of N. gonorrhoeae.
Time Frame: From Month 4 to Month 24
Detection of the first instance of N. gonorrhoeae infection in a urine sample or on a swab taken from the urethra, anorectum, oropharynx or vagina, as determined by nucleic acid amplification (NAAT) testing.
From Month 4 to Month 24
To compare the overall incidence of all episodes of N. gonorrhoeae infection diagnosed during the study period between the vaccine and placebo arms.
Time Frame: From Month 4 to Month 24
To compare the overall incidence of all episodes of N. gonorrhoeae infection diagnosed during the study period between the vaccine and placebo arms, allowing multiple diagnoses of N. gonorrhoeae infection occurred in the same individuals at different time points.
From Month 4 to Month 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To measure the impact of administration of a 2-dose regimen of 4CMenB vaccine on the incidence of the first episode of symptomatic N. gonorrhoeae infection of the urethra, anorectum or vagina.
Time Frame: From Month 4 to Month 24
Symptomatic N. gonorrhoeae infection - first instance of the detection of N. gonorrhoeae infection in a urine sample or on a swab taken from the urethra, anorectum or vagina at a study visit when a participant also reports any symptoms at the relevant anatomic site.
From Month 4 to Month 24
To measure the impact of administration of a 2-dose regimen of 4CMenB vaccine on the incidence of the first episode of asymptomatic N. gonorrhoeae infection of the urethra, anorectum, oropharynx or vagina.
Time Frame: From Month 4 to Month 24
Asymptomatic N. gonorrhoeae infection - first instance of the detection of N. gonorrhoeae infection in a urine sample or on a swab taken from the urethra, anorectum, oropharynx or vagina at a study visit when a participant reports no symptoms at the relevant anatomic site.
From Month 4 to Month 24
To measure the impact of administration of a 2-dose regimen of 4CMenB vaccine on the incidence of first episode of N. gonorrhoeae infection, regardless of symptoms and anatomic sites, by various N. gonorrhoeae strain types (genotype and AMR phenotype).
Time Frame: From Month 4 to Month 24
Strain specific (by whole genome sequence or antimicrobial resistance phenotype) - first instance of the detection of N. gonorrhoeae infection in a urine sample or on a swab taken from the urethra, anorectum, oropharynx or vagina, at a study visit.
From Month 4 to Month 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate if the N. gonorrhoeae-specific enzyme-linked immunosorbent assay (ELISA) titres increase following 4CMenB vaccination.
Time Frame: From Baseline through to Month 3
The enzyme-linked immunosorbent assay (ELISA) of serum and oral mucosal transudates post 4CMenB dose 1 and dose 2, relative to baseline.
From Baseline through to Month 3
To evaluate if the N. gonorrhoeae-specific serum bactericidal activity assay titres increase following 4CMenB vaccination.
Time Frame: From Baseline through to Month 3
The serum bactericidal activity (SBA) titres of serum post 4CMenB dose 1 and dose 2, relative to baseline.
From Baseline through to Month 3
To evaluate if the serum opsonophagocytic killing assay (OPK) titres increase following 4CMenB vaccination.
Time Frame: From Baseline through to Month 3
The opsonophagocytic killing (OPK) titres of serum post 4CMenB dose 1 and dose 2, relative to baseline.
From Baseline through to Month 3
To evaluate if the N. gonorrhoeae-specific ELISA correlate with reduced N. gonorrhoeae infection.
Time Frame: From Baseline through to Month 24
The ELISA titres of serum during the study period.
From Baseline through to Month 24
To evaluate if the N. gonorrhoeae-specific titres correlate with reduced N. gonorrhoeae infection.
Time Frame: From Baseline through to Month 24
The SBA titres of serum during the study period.
From Baseline through to Month 24
To evaluate if the N. gonorrhoeae-specific OPK titres correlate with reduced N. gonorrhoeae infection.
Time Frame: From Baseline through to Month 24
The OPK titres of serum during the study period.
From Baseline through to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirby Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Griffith University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Professor Kate Seib, BSc(Hon),PhD, Institute for Glycomics, Griffith University, Queensland, Australia
  • Principal Investigator: Professor Basil Donovan, MBBS, MD, The Kirby Institute, University of New South Wales Sydney, Australia
  • Principal Investigator: Professor Andrew Grulich, MBBS, PhD, The Kirby Institute, University of New South Wales Sydney, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEPP2001
  • APP1182443 (Other Grant/Funding Number: National Health and Medical Research Council, Australia)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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