Status:
ACTIVE_NOT_RECRUITING
Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
Griffith University
Conditions:
Neisseria Gonorrheae Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
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 Nei...
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 Nei...
Eligibility Criteria
Inclusion
- 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
- Have a previous history of vaccination for meningococcal B with 4CMenB
- 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
Key Trial Info
Start Date :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT04415424
Start Date
July 8 2021
End Date
October 30 2025
Last Update
March 24 2025
Active Locations (7)
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1
Western Sydney Sexual Health Centre
Parramatta, New South Wales, Australia, 2150
2
Sydney Sexual Health Centre
Sydney, New South Wales, Australia, 2000
3
Taylor Square Private Clinic
Sydney, New South Wales, Australia, 2010
4
RPA Sexual Health
Sydney, New South Wales, Australia, 2050