Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001478101
Ethics application status
Approved
Date submitted
1/10/2019
Date registered
25/10/2019
Date last updated
10/12/2023
Date data sharing statement initially provided
25/10/2019
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
RGS201800015
Universal Trial Number (UTN)
U1111-1226-7838
Trial acronym
MenGO
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

Intervention/exposure
Study type
Interventional
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
Prevention
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
Active

Outcomes
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

Eligibility
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
Sex
Males
Can healthy volunteers participate?
Yes
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
Prevention
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
Parallel
Other design features
N/a
Phase
Phase 4
Type of endpoint/s
Efficacy
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2020
Actual
21/01/2020
Date of last participant enrolment
Anticipated
1/01/2023
Actual
29/04/2022
Date of last data collection
Anticipated
1/01/2025
Actual
7/12/2023
Sample size
Target
130
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
QLD
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
Charities/Societies/Foundations
Name [1] 301625 0
Gold Coast Hospital Foundation
Country [1] 301625 0
Australia
Funding source category [2] 301630 0
Hospital
Name [2] 301630 0
Gold Coast Hospital and Health Service
Country [2] 301630 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Gold Coast University Hospital,
1 Hospital Boulevard,
Southport, 4215, Queensland
Country
Australia
Secondary sponsor category [1] 301333 0
None
Name [1] 301333 0
Address [1] 301333 0
Country [1] 301333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302350 0
Gold Coast Hospital Ethics Committee
Ethics committee address [1] 302350 0
Ethics committee country [1] 302350 0
Australia
Date submitted for ethics approval [1] 302350 0
16/01/2019
Approval date [1] 302350 0
30/09/2019
Ethics approval number [1] 302350 0
HREC/2019/QGC/48972

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 89918 0
+61 756879200
Fax 89918 0
+61756879212
Email 89918 0
[email protected]
Contact person for public queries
Name 89919 0
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
Australia
Phone 89919 0
+61 756879200
Fax 89919 0
+61756879212
Email 89919 0
[email protected]
Contact person for scientific queries
Name 89920 0
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
Australia
Phone 89920 0
+61 756879200
Fax 89920 0
+61756879212
Email 89920 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseGonorrhoea: Past, present and future.2020https://dx.doi.org/10.1071/ma20055
Dimensions AIOuter membrane vesicle vaccines for Neisseria gonorrhoeae2021https://doi.org/10.1038/s41585-021-00534-5
N.B. These documents automatically identified may not have been verified by the study sponsor.