MenGO: Does the licensed meningococcal vaccine Bexsero® provide cross- protection against gonorrhoea?
MenGO: Does the licensed meningococcal vaccine Bexsero® provide cross- protection against gonorrhoea in gay and bisexual men?
Gold Coast Hospital and Health Service
130 participants
Jan 21, 2020
Interventional
Conditions
Summary
MenGO is a Phase III open-label randomised control study in gay and bisexual men, comparing the incidence of gonorrhoea infection in those vaccinated with Bexsero® to those who do not receive the vaccine. The study will test the hypotheses that a reduction in number of gonorrhoea infections will be seen following vaccination with Bexero. It will also investigate Bexsero®-induced antibodies that will inform rational novel vaccine design and show that Bexsero® is a safe vaccine for administration in GBM aged 18-50 years.
Eligibility
Inclusion Criteria10
- Participants can be included in the study if they are:
- Older than>18 years of age
- Able to understand spoken and written English
- Male who has sex with other men
- Able to participate in study procedures including attending for all study visits
- At risk of acquisition of gonorrhoea at the time of enrolment into the study
- Agree to be contacted via phone/ email by the study team
- AND are:
- Currently taking HIV pre-exposure prophylaxis (PrEP) at the time of enrolment OR
- Been diagnosed with gonorrhoea in the last 3 months
Exclusion Criteria6
- Patients will be excluded from participation if they have:
- Confirmed previous history of vaccination for Meningococcal B with Bexsero®)
- Contraindications to receiving the Meningococcal B vaccine which include:
- Anaphylaxis following a previous dose of any meningococcal vaccine
- Anaphylaxis following any vaccine component
- (previous meningococcal disease and previous vaccination with the strain specific meningococcal B vaccine MeNZB is not a contraindication for receiving Bexsero®)
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Interventions
Randomised controlled trial of Meningococcal B vaccine (Bexsero) for the prevention of gonorrhoea infection in men who have sex with men Arm 1 - control/ no vaccination Arm 2 - will recieve a 0.5ml dose of Bexsero intramuscularly at the time of enrolment and a second dose in 3 months
Locations(1)
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ACTRN12619001478101