<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04415424</url>
  </required_header>
  <id_info>
    <org_study_id>HEPP2001</org_study_id>
    <secondary_id>APP1182443</secondary_id>
    <nct_id>NCT04415424</nct_id>
  </id_info>
  <brief_title>Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men</brief_title>
  <acronym>GoGoVax</acronym>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kirby Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Griffith University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kirby Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3, double-blinded, randomised placebo-controlled, multi-centred trial&#xD;
      evaluating the efficacy of the four-component meningococcal B vaccine, 4CMenB (Bexsero®), in&#xD;
      the prevention of Neisseria gonorrhoeae infection.The targeted population is 18-50 years-old&#xD;
      men (cis and trans), trans women and non-binary people who have sex with men (hereafter&#xD;
      referred to as Gay Bisexual Men+ [GBM+], either HIV-negative and taking pre-exposure&#xD;
      prophylaxis [PrEP], or HIV-positive with undetectable viral load &lt;200copies/ml and a cluster&#xD;
      of differentiation 4 [CD4] count &gt;350 cells/cmm) who have high N. gonorrhoeae incidence and&#xD;
      are recommended by Australian guidelines to have regular, comprehensive sexual health&#xD;
      screening. 730 participants will be enrolled and randomised 1:1 and stratified by clinical&#xD;
      sites to receive two doses of 4CMenB vaccine or a matching placebo at 0 and 3 months by&#xD;
      intramuscular injection. Recruitment is for 12 months and all participants will be follow-up&#xD;
      3-monthly for a period of 2 years. The trial aims to evaluate the efficacy of 4CMenB in the&#xD;
      prevention of N. gonorrhoeae infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 3, double-blinded, randomised placebo-controlled, multi-centred trial&#xD;
      evaluating the efficacy of the four-component meningococcal B vaccine, 4CMenB (Bexsero®), in&#xD;
      the prevention of Neisseria gonorrhoeae infection.The target population for this trial is&#xD;
      GBM+, either HIV-negative and on PrEP or HIV-positive, who had a diagnosis of gonorrhoea or&#xD;
      infectious syphilis in the last 18 months (a key characteristic associated with greater&#xD;
      gonorrhoea risk). This population has the highest known gonococcal incidence and are&#xD;
      recommended under Australian guidelines to attend clinics 3-monthly for comprehensive sexual&#xD;
      health screening, including Nuclei acid amplification test (NAAT)-based screening of urine,&#xD;
      and pharyngeal and anal specimens for N. gonorrhoeae infection. 730 participants will be&#xD;
      enrolled and randomised 1:1 and stratified by clinical sites to receive two doses of 4CMenB&#xD;
      vaccine or a matching placebo at 0 and 3 months by intramuscular injection. Recruitment will&#xD;
      occur over a 12-month period and all participants will be followed up 3-monthly over a period&#xD;
      of 2 years. Participants, their study clinicians and study researchers assessing the outcomes&#xD;
      will be blinded to the treatment arm (vaccine or placebo). Participants will be required to&#xD;
      attend approximately 10 study visits. Participants may attend additional visits if they have&#xD;
      been diagnosed with gonorrhoea infection (symptomatic or asymptomatic) or have a postitive&#xD;
      gonorrhoea NAAT test when they return for test of cure. Potentially eligible individuals will&#xD;
      be screened within 14 days of baseline (the visit when the first dose of study treatment is&#xD;
      administered). Randomisation can be conducted any time between screening and baseline.&#xD;
      Screening, randomisation and baseline can occur on the same day if the required HIV result(s)&#xD;
      and drug kit (containing 4CMenB or placebo) are available for a participant in the clinic. At&#xD;
      screening, study clinicians will conduct the informed consent process with a participant and&#xD;
      the informed consent will be signed by both the study clinician and the participant.&#xD;
      Eligibility criteria will be checked and a review of medical history (including vaccination&#xD;
      history for 4CMenB, prior known meningococcal disease, recent history of sexually transmitted&#xD;
      infections [STIs], history of taking PrEP [for HIV negative individuals] as well as&#xD;
      antibiotic use in the last 3 months) will be conducted. Routine blood, urine and swabs will&#xD;
      be collected, and urine pregnancy test will be performed in participants with child-bearing&#xD;
      potential. Symptoms of urethritis, proctitis, epididymitis, and cervicitis/vaginitis will be&#xD;
      documented. At randomisation (which can occur anytime within screening an baseline),&#xD;
      participants will be randomised to receive either the 4CMenB vaccine or the placebo. At the&#xD;
      baseline visit, research blood specimen and an oral mucosal exudate swab for immune responses&#xD;
      testing will be collected before the administration of the first dose of the study treatment.&#xD;
      A 10-minute study questionnaire will be completed by the participants. Participants will&#xD;
      return to their study site 3 months after the first dose of study treatment to receive the&#xD;
      second dose. Prior to the treatment administration, urine pregnancy test (in participants&#xD;
      with child-bearing potential) will be conducted. Symptoms of urethritis, proctitis,&#xD;
      epididymitis, and cervicitis/vaginitis will be documented. History of antibiotic use in the&#xD;
      last 3 months will also be collected. If a participant has tested positive for gonorrhoea&#xD;
      infection, routinely collected culture isolates and NAAT samples will be stored in a study&#xD;
      research laboratory for phenotypic antimicrobial resistance (AMR) testing and genotyping.&#xD;
      Routine blood, urine and swabs will also be collected. Adverse events and serious adverse&#xD;
      events (SAEs) will be recorded but only SAEs will be entered into the study electronic data&#xD;
      capture system, and reported to the Sponsor in real time. Three-monthly visits will be&#xD;
      conducted over a period of 2 years. The study aims to evaluate the efficacy of 4CMenB in the&#xD;
      prevention of N. gonorrhoeae infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 8, 2021</start_date>
  <completion_date type="Anticipated">February 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomised 1:1 to receive 4CMenB vaccine or a matching placebo</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants, their study clinicians and study researchers assessing the outcomes will be blinded to the treatment arm (4CMenB vaccine or placebo).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>From Month 4 to Month 24</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To compare the overall incidence of all episodes of N. gonorrhoeae infection diagnosed during the study period between the vaccine and placebo arms.</measure>
    <time_frame>From Month 4 to Month 24</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From Month 4 to Month 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From Month 4 to Month 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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).</measure>
    <time_frame>From Month 4 to Month 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To evaluate if the N. gonorrhoeae-specific enzyme-linked immunosorbent assay (ELISA) titres increase following 4CMenB vaccination.</measure>
    <time_frame>From Baseline through to Month 3</time_frame>
    <description>The enzyme-linked immunosorbent assay (ELISA) of serum and oral mucosal transudates post 4CMenB dose 1 and dose 2, relative to baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>To evaluate if the N. gonorrhoeae-specific serum bactericidal activity assay titres increase following 4CMenB vaccination.</measure>
    <time_frame>From Baseline through to Month 3</time_frame>
    <description>The serum bactericidal activity (SBA) titres of serum post 4CMenB dose 1 and dose 2, relative to baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>To evaluate if the serum opsonophagocytic killing assay (OPK) titres increase following 4CMenB vaccination.</measure>
    <time_frame>From Baseline through to Month 3</time_frame>
    <description>The opsonophagocytic killing (OPK) titres of serum post 4CMenB dose 1 and dose 2, relative to baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>To evaluate if the N. gonorrhoeae-specific ELISA correlate with reduced N. gonorrhoeae infection.</measure>
    <time_frame>From Baseline through to Month 24</time_frame>
    <description>The ELISA titres of serum during the study period.</description>
  </other_outcome>
  <other_outcome>
    <measure>To evaluate if the N. gonorrhoeae-specific titres correlate with reduced N. gonorrhoeae infection.</measure>
    <time_frame>From Baseline through to Month 24</time_frame>
    <description>The SBA titres of serum during the study period.</description>
  </other_outcome>
  <other_outcome>
    <measure>To evaluate if the N. gonorrhoeae-specific OPK titres correlate with reduced N. gonorrhoeae infection.</measure>
    <time_frame>From Baseline through to Month 24</time_frame>
    <description>The OPK titres of serum during the study period.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">652</enrollment>
  <condition>Neisseria Gonorrheae Infection</condition>
  <arm_group>
    <arm_group_label>Treatment arm A - 4CMenB vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment arm B - placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>4CMenB vaccine</intervention_name>
    <description>A four-component meningococcal B vaccine</description>
    <arm_group_label>Treatment arm A - 4CMenB vaccine</arm_group_label>
    <other_name>Bexsero®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.5 ml of 150 mmol sodium chloride (0.9% saline solution)</description>
    <arm_group_label>Treatment arm B - placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 18 to ≤ 50 years of age&#xD;
&#xD;
          2. Men (cis and trans), trans women and non-binary people who have had sex with at least&#xD;
             one man in the last 6 months&#xD;
&#xD;
          3. Diagnosis of gonorrhoea or infectious syphilis in the last 18 months&#xD;
&#xD;
          4. Committed not to take doxycycline as prophylaxis for the duration of the trial&#xD;
&#xD;
          5. Able to understand spoken and written English&#xD;
&#xD;
          6. Willing and likely to comply with the trial procedures for 2 years&#xD;
&#xD;
          7. Agree to be contacted via short message service (SMS)/phone/ email by the study team&#xD;
&#xD;
        AND EITHER&#xD;
&#xD;
          1. HIV-negative (with an HIV negative antibody test within 4 months of screening) and&#xD;
             taking HIV PrEP (daily PrEP or on-demand PrEP) within the last 4 months at the time of&#xD;
             enrolment or&#xD;
&#xD;
          2. HIV-positive and on an antiviral regimen, with an undetectable virus level of &lt;200&#xD;
             copies/ml and a CD4 count &gt;350 cells/cmm (to optimise the immune response to vaccine)&#xD;
             within 12 months of screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a previous history of vaccination for meningococcal B with 4CMenB&#xD;
&#xD;
          2. Have contraindications to receiving the meningococcal B vaccine which include:&#xD;
&#xD;
               -  Anaphylaxis following a previous dose of any meningococcal vaccine&#xD;
&#xD;
               -  Anaphylaxis following any vaccine component&#xD;
&#xD;
          3. Are participating in biomedical prevention strategies for bacterial STIs&#xD;
             (participation in diagnostic or treatment studies is not an exclusion)&#xD;
&#xD;
          4. Are taking long-term (&gt; 4 weeks) antibiotic for prophylaxis or treatment for acne,&#xD;
             malaria, syphilis or other bacterial condition(s)&#xD;
&#xD;
          5. Have defects in, or deficiency of, complement components, including factor H, factor D&#xD;
             or properdin deficiency&#xD;
&#xD;
          6. Are taking or will receive complement inhibitors such as eculizumab (a monoclonal&#xD;
             antibody directed against complement component C5) or ravulizumab&#xD;
&#xD;
          7. Have functional or anatomical asplenia, including sickle cell disease or other&#xD;
             haemoglobinopathies, and congenital or acquired asplenia&#xD;
&#xD;
          8. Have had a haematopoietic stem cell transplant&#xD;
&#xD;
          9. Have any major unstable medical condition or therapy that may cause immune compromise&#xD;
             (e.g. chemotherapy, radiation, corticosteroids [prednisone &gt;5mg/day] within 14 days&#xD;
             prior to screening)&#xD;
&#xD;
         10. Documented allergy to latex and/or kanamycin&#xD;
&#xD;
         11. Have prior known meningococcal disease&#xD;
&#xD;
         12. Positive pregnancy test at screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>High risk men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as GBM+)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Professor Kate Seib, BSc(Hon),PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Institute for Glycomics, Griffith University, Queensland, Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Professor Basil Donovan, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Kirby Institute, University of New South Wales Sydney, Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Professor Andrew Grulich, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Kirby Institute, University of New South Wales Sydney, Australia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Western Sydney Sexual Health Centre</name>
      <address>
        <city>Parramatta</city>
        <state>New South Wales</state>
        <zip>2150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydney Sexual Health Centre</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taylor Square Private Clinic</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RPA Sexual Health</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gold Coast Sexual Health Service</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melbourne Sexual Health Centre</name>
      <address>
        <city>Carlton</city>
        <state>Victoria</state>
        <zip>3053</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prahran Market Clinic</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3181</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Gonorrhea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415424
org study id: HEPP2001
secondary id: APP1182443
nct id: NCT04415424
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised 1:1 to receive 4CMenB vaccine or a matching placebo
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participants, their study clinicians and study researchers assessing the outcomes will be blinded to the treatment arm (4CMenB vaccine or placebo).
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: The enzyme-linked immunosorbent assay (ELISA) of serum and oral mucosal transudates post 4CMenB dose 1 and dose 2, relative to baseline.
measure: To evaluate if the N. gonorrhoeae-specific serum bactericidal activity assay titres increase following 4CMenB vaccination.
time frame: From Baseline through to Month 3
description: The serum bactericidal activity (SBA) titres of serum post 4CMenB dose 1 and dose 2, relative to baseline.
measure: To evaluate if the serum opsonophagocytic killing assay (OPK) titres increase following 4CMenB vaccination.
time frame: From Baseline through to Month 3
description: The opsonophagocytic killing (OPK) titres of serum post 4CMenB dose 1 and dose 2, relative to baseline.
measure: To evaluate if the N. gonorrhoeae-specific ELISA correlate with reduced N. gonorrhoeae infection.
time frame: From Baseline through to Month 24
description: The ELISA titres of serum during the study period.
measure: To evaluate if the N. gonorrhoeae-specific titres correlate with reduced N. gonorrhoeae infection.
time frame: From Baseline through to Month 24
description: The SBA titres of serum during the study period.
measure: To evaluate if the N. gonorrhoeae-specific OPK titres correlate with reduced N. gonorrhoeae infection.
time frame: From Baseline through to Month 24
description: The OPK titres of serum during the study period.
arm group label: Treatment arm A - 4CMenB vaccine
arm group type: Experimental
description: 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).
arm group label: Treatment arm B - placebo
arm group type: Placebo Comparator
description: 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).
intervention type: Biological
intervention name: 4CMenB vaccine
description: A four-component meningococcal B vaccine
arm group label: Treatment arm A - 4CMenB vaccine
other name: Bexsero®
intervention type: Other
intervention name: Placebo
description: 0.5 ml of 150 mmol sodium chloride (0.9% saline solution)
arm group label: Treatment arm B - placebo
criteria: 
gender: All
gender based: Yes
gender description: High risk men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as GBM+)
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Professor Kate Seib, BSc(Hon),PhD
role: Study Chair
affiliation: Institute for Glycomics, Griffith University, Queensland, Australia
last name: Professor Basil Donovan, MBBS, MD
role: Principal Investigator
affiliation: The Kirby Institute, University of New South Wales Sydney, Australia
last name: Professor Andrew Grulich, MBBS, PhD
role: Principal Investigator
affiliation: The Kirby Institute, University of New South Wales Sydney, Australia
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country: Australia
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Gonorrhea