Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men (GoGoVax)
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ClinicalTrials.gov Identifier: NCT04415424 |
Recruitment Status :
Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : May 25, 2023
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Condition or disease | Intervention/treatment | Phase |
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Neisseria Gonorrheae Infection | Biological: 4CMenB vaccine Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 652 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomised 1:1 to receive 4CMenB vaccine or a matching placebo |
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). |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | July 8, 2021 |
Estimated Primary Completion Date : | October 2024 |
Estimated Study Completion Date : | February 2025 |
Arm | Intervention/treatment |
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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).
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Biological: 4CMenB vaccine
A four-component meningococcal B vaccine
Other Name: 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).
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Other: Placebo
0.5 ml of 150 mmol sodium chloride (0.9% saline solution) |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | High risk men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as GBM+) |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Between 18 to ≤ 50 years of age
- Men (cis and trans), trans women and non-binary people who have had sex with at least one man in the last 6 months
- Diagnosis of gonorrhoea or infectious syphilis in the last 18 months
- Committed not to take doxycycline as prophylaxis for the duration of the trial
- Able to understand spoken and written English
- Willing and likely to comply with the trial procedures for 2 years
- Agree to be contacted via short message service (SMS)/phone/ email by the study team
AND EITHER
- 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
- 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:
- Have a previous history of vaccination for meningococcal B with 4CMenB
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Have contraindications to receiving the meningococcal B vaccine which include:
- Anaphylaxis following a previous dose of any meningococcal vaccine
- Anaphylaxis following any vaccine component
- Are participating in biomedical prevention strategies for bacterial STIs (participation in diagnostic or treatment studies is not an exclusion)
- Are taking long-term (> 4 weeks) antibiotic for prophylaxis or treatment for acne, malaria, syphilis or other bacterial condition(s)
- Have defects in, or deficiency of, complement components, including factor H, factor D or properdin deficiency
- Are taking or will receive complement inhibitors such as eculizumab (a monoclonal antibody directed against complement component C5) or ravulizumab
- Have functional or anatomical asplenia, including sickle cell disease or other haemoglobinopathies, and congenital or acquired asplenia
- Have had a haematopoietic stem cell transplant
- 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)
- Documented allergy to latex and/or kanamycin
- Have prior known meningococcal disease
- Positive pregnancy test at screening
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415424
Australia, New South Wales | |
Western Sydney Sexual Health Centre | |
Parramatta, New South Wales, Australia, 2150 | |
Sydney Sexual Health Centre | |
Sydney, New South Wales, Australia, 2000 | |
Taylor Square Private Clinic | |
Sydney, New South Wales, Australia, 2010 | |
RPA Sexual Health | |
Sydney, New South Wales, Australia, 2050 | |
Australia, Queensland | |
Gold Coast Sexual Health Service | |
Southport, Queensland, Australia, 4215 | |
Australia, Victoria | |
Melbourne Sexual Health Centre | |
Carlton, Victoria, Australia, 3053 | |
Prahran Market Clinic | |
Melbourne, Victoria, Australia, 3181 |
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 |
Responsible Party: | Kirby Institute |
ClinicalTrials.gov Identifier: | NCT04415424 |
Other Study ID Numbers: |
HEPP2001 APP1182443 ( Other Grant/Funding Number: National Health and Medical Research Council, Australia ) |
First Posted: | June 4, 2020 Key Record Dates |
Last Update Posted: | May 25, 2023 |
Last Verified: | May 2023 |
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 |
Infections Communicable Diseases Gonorrhea Disease Attributes Pathologic Processes Neisseriaceae Infections Gram-Negative Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Genital Diseases Urogenital Diseases |