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?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001478101

Acronym

MenGO

Enrollment

130

Registered

2019-10-25

Start date

2020-01-21

Completion date

2022-04-29

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

Yes

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®)

Outcome results