COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
MenGO: Does the licensed meningococcal vaccine Bexsero® provide cross- protection against gonorrhoea?
Scientific title
MenGO: Does the licensed meningococcal vaccine Bexsero® provide cross- protection against gonorrhoea in gay and bisexual men?
Secondary ID [1] 297054 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gonorrhoea infection 311054 0
Meningococcal B vaccine 311055 0
Condition category
Condition code
Infection 309690 309690 0 0
Sexually transmitted infections

Study type
Description of intervention(s) / exposure
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
Intervention code [1] 313330 0
Comparator / control treatment
Men who have sex with men who are at risk of gonorrhea infection (as indicated by sexual history, currently taking pre-exposure propyhylaxis for HIV infection or gonorrhoea infection in the last 3 months). The control group will not recieve any vaccination/ intervention.
Control group

Primary outcome [1] 318658 0
Number 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.
Timepoint [1] 318658 0
Months 3, 6, 12, 15, 18, 21, 24 after enrolment and at any other unscheduled visit if a gonorrhoea test is performed
Primary outcome [2] 318659 0
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)
Timepoint [2] 318659 0
Pre-vaccination and 3, 6, 12 and 24 months post vaccine
Secondary outcome [1] 365604 0
Number of SAEs reported where the cause has been determined to be related to the study treatment as assessed by:
- clinical examination at study visits (physical, temperature, blood pressure, heart rate)
- clinical observation (+/- examination) at study site 20 minutes post vaccination
- patient self-reported diary with study specific questionnaire
Bexsero is already licenced for use in Australia for the study population. Known adverse events include:
Nervous system disorders - headache
Gastrointestinal disorders - nausea
General disorders and administration site conditions - injection site pain (including severe injection site pain defined as unable to perform normal daily activity), injection site swelling, injection site induration, injection site, erythema, malaise
Musculoskeletal and connective tissue disorders - myalgia, arthralgia
Timepoint [1] 365604 0
3-monthly post vaccination over 24 months
Secondary outcome [2] 375721 0
Number of patients consented to the trial compared to number of participants where pre-screening was performed
Timepoint [2] 375721 0
Pre-screening and baseline

Key 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
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis
Aim 1 - Incidence of gonorrhoea will be measured by N. gonorrhoeae confirmed by polymerase
chain reaction (PCR). To achieve statistical power for the study, based on a gonococcal
prevalence of 29.4% in our PrEP target group, it is estimated that 112 patients will be
required to be recruited within this study (80% power to reduce incidence from 30% to
10% reduction at a significance level of 0.05). We will investigate associations between
Bexsero vaccination status and the incidence of gonorrhoea using t-test and mixed effects
logistic regression models. Associations with other STIs and patient demographics will also be considered.
Aim 2 - For the functional assays, gonococcal numbers (based on counting colony
forming units in serial dilutions) at the end of each assay are calculated as a percentage
relative to no-antibody control. The titre is defined as the reciprocal of the final serum
dilution giving greater than or equal to 50% killing or inhibition of adherence. P-values are determined using
Kruskal-Wallis nonparametric analysis or Student’s t-test as appropriate.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 12874 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 25354 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 301625 0
Name [1] 301625 0
Gold Coast Hospital Foundation
Address [1] 301625 0
Gold Coast University Hospital,
1 Hospital Boulevard,
Southport, 4215, Queensland
Country [1] 301625 0
Funding source category [2] 301630 0
Name [2] 301630 0
Gold Coast Hospital and Health Service
Address [2] 301630 0
Gold Coast University Hospital,
1 Hospital Boulevard,
Southport, 4215, Queensland
Country [2] 301630 0
Primary sponsor type
Gold Coast Hospital and Health Service
Gold Coast University Hospital,
1 Hospital Boulevard,
Southport, 4215, Queensland
Secondary sponsor category [1] 301333 0
Name [1] 301333 0
Address [1] 301333 0
Country [1] 301333 0

Ethics approval
Ethics application status
Ethics committee name [1] 302350 0
Gold Coast Hospital Ethics Committee
Ethics committee address [1] 302350 0
Gold Coast University Hospital,
1 Hospital Boulevard,
Southport, 4215, Queensland
Ethics committee country [1] 302350 0
Date submitted for ethics approval [1] 302350 0
Approval date [1] 302350 0
Ethics approval number [1] 302350 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 89918 0
Dr Caroline Thng
Address 89918 0
Gold Coast Sexual Health Service
16-20 High Street
Level 4, Southport Community Health Precinct
Southport 4215, Queensland
Country 89918 0
Phone 89918 0
+61 756879200
Fax 89918 0
Email 89918 0
Contact person for public queries
Name 89919 0
Dr Caroline Thng
Address 89919 0
Gold Coast Sexual Health Service
16-20 High Street
Level 4, Southport Community Health Precinct
Southport 4215, Queensland
Country 89919 0
Phone 89919 0
+61 756879200
Fax 89919 0
Email 89919 0
Contact person for scientific queries
Name 89920 0
Dr Caroline Thng
Address 89920 0
Gold Coast Sexual Health Service
16-20 High Street
Level 4, Southport Community Health Precinct
Southport 4215, Queensland
Country 89920 0
Phone 89920 0
+61 756879200
Fax 89920 0
Email 89920 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results