MenGO: Does the licensed meningococcal vaccine Bexsero® provide cross- protection against gonorrhoea?

Phase 4

Completed

• Conditions: Meningococcal B vaccine; Infection - Sexually transmitted infections; Gonorrhoea infection

• Registration Number: ACTRN12619001478101
• Lead Sponsor: Gold Coast Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-25
• Study Completion: 2023-12-07
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

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 Criteria

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®)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of Neisseria gonorrhoeae infections detection by nucleic acid amplification test (NAAT) from pharyngeal, rectal and first catch urine, at any time point during the study period excluding Baseline visit. [ Months 3, 6, 12, 15, 18, 21, 24 after enrolment and at any other unscheduled visit if a gonorrhoea test is performed ];Serum Neisseria gonorrhoeae antibody ELISA titre and dominant antibody isotype (IgG, IgA and IgM), as well as the SBA, OPA and adherence blocking titres of samples taken at 0, 3, 6, 12, 24 months during the study period (composite outcome)[ Pre-vaccination and 3, 6, 12 and 24 months post vaccine]