Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04415424




Registration number
NCT04415424
Ethics application status
Date submitted
19/05/2020
Date registered
4/06/2020
Date last updated
25/05/2023

Titles & IDs
Public title
Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men
Scientific title
A Multi-centre Randomised Controlled Trial Evaluating the Efficacy of the Four-component Meningococcal B Vaccine, 4CMenB (Bexsero®), in the Prevention of Neisseria Gonorrhoeae Infection in Gay and Bisexual Men
Secondary ID [1] 0 0
APP1182443
Secondary ID [2] 0 0
HEPP2001
Universal Trial Number (UTN)
Trial acronym
GoGoVax
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neisseria Gonorrheae Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 4CMenB vaccine
Other interventions - Placebo

Experimental: Treatment arm A - 4CMenB vaccine - 4CMenB vaccine will be administered as an intramuscular injection in 0.5 ml single-dose pre-filled syringe in two doses with 3-month apart (at Baseline and Month 3 visit).

Placebo comparator: Treatment arm B - placebo - Placebo will be administered as an intramuscular injection in 0.5 ml single dose pre-filled syringe in two doses with 3-month apart (at Baseline and Month 3 visit).


Treatment: Other: 4CMenB vaccine
A four-component meningococcal B vaccine

Other interventions: Placebo
0.5 ml of 150 mmol sodium chloride (0.9% saline solution)
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To measure whether the 4CMenB vaccine, when administered in a 2-dose regimen at 0 and 3 months, changes the incidence of the first episode of N. gonorrhoeae.
Timepoint [1] 0 0
From Month 4 to Month 24
Primary outcome [2] 0 0
To compare the overall incidence of all episodes of N. gonorrhoeae infection diagnosed during the study period between the vaccine and placebo arms.
Timepoint [2] 0 0
From Month 4 to Month 24
Secondary outcome [1] 0 0
To measure the impact of administration of a 2-dose regimen of 4CMenB vaccine on the incidence of the first episode of symptomatic N. gonorrhoeae infection of the urethra, anorectum or vagina.
Timepoint [1] 0 0
From Month 4 to Month 24
Secondary outcome [2] 0 0
To measure the impact of administration of a 2-dose regimen of 4CMenB vaccine on the incidence of the first episode of asymptomatic N. gonorrhoeae infection of the urethra, anorectum, oropharynx or vagina.
Timepoint [2] 0 0
From Month 4 to Month 24
Secondary outcome [3] 0 0
To measure the impact of administration of a 2-dose regimen of 4CMenB vaccine on the incidence of first episode of N. gonorrhoeae infection, regardless of symptoms and anatomic sites, by various N. gonorrhoeae strain types (genotype and AMR phenotype).
Timepoint [3] 0 0
From Month 4 to Month 24

Eligibility
Key inclusion criteria
1. Between 18 to = 50 years of age
2. Men (cis and trans), trans women and non-binary people who have had sex with at least one man in the last 6 months
3. Diagnosis of gonorrhoea or infectious syphilis in the last 18 months
4. Committed not to take doxycycline as prophylaxis for the duration of the trial
5. Able to understand spoken and written English
6. Willing and likely to comply with the trial procedures for 2 years
7. Agree to be contacted via short message service (SMS)/phone/ email by the study team

AND EITHER

1. HIV-negative (with an HIV negative antibody test within 4 months of screening) and taking HIV PrEP (daily PrEP or on-demand PrEP) within the last 4 months at the time of enrolment or
2. HIV-positive and on an antiviral regimen, with an undetectable virus level of <200 copies/ml and a CD4 count >350 cells/cmm (to optimise the immune response to vaccine) within 12 months of screening
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a previous history of vaccination for meningococcal B with 4CMenB
2. Have contraindications to receiving the meningococcal B vaccine which include:

* Anaphylaxis following a previous dose of any meningococcal vaccine
* Anaphylaxis following any vaccine component
3. Are participating in biomedical prevention strategies for bacterial STIs (participation in diagnostic or treatment studies is not an exclusion)
4. Are taking long-term (> 4 weeks) antibiotic for prophylaxis or treatment for acne, malaria, syphilis or other bacterial condition(s)
5. Have defects in, or deficiency of, complement components, including factor H, factor D or properdin deficiency
6. Are taking or will receive complement inhibitors such as eculizumab (a monoclonal antibody directed against complement component C5) or ravulizumab
7. Have functional or anatomical asplenia, including sickle cell disease or other haemoglobinopathies, and congenital or acquired asplenia
8. Have had a haematopoietic stem cell transplant
9. Have any major unstable medical condition or therapy that may cause immune compromise (e.g. chemotherapy, radiation, corticosteroids [prednisone >5mg/day] within 14 days prior to screening)
10. Documented allergy to latex and/or kanamycin
11. Have prior known meningococcal disease
12. Positive pregnancy test at screening

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
Accrual to date
Final
652
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Western Sydney Sexual Health Centre - Parramatta
Recruitment hospital [2] 0 0
Sydney Sexual Health Centre - Sydney
Recruitment hospital [3] 0 0
Taylor Square Private Clinic - Sydney
Recruitment hospital [4] 0 0
RPA Sexual Health - Sydney
Recruitment hospital [5] 0 0
Gold Coast Sexual Health Service - Southport
Recruitment hospital [6] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [7] 0 0
Prahran Market Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
2150 - Parramatta
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3053 - Carlton
Recruitment postcode(s) [7] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Griffith University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 3, double-blinded, randomised placebo-controlled, multi-centred trial evaluating the efficacy of the four-component meningococcal B vaccine, 4CMenB (Bexsero®), in the prevention of Neisseria gonorrhoeae infection.The targeted population is 18-50 years-old men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as Gay Bisexual Men+ \[GBM+\], either HIV-negative and taking pre-exposure prophylaxis \[PrEP\], or HIV-positive with undetectable viral load \<200copies/ml and a cluster of differentiation 4 \[CD4\] count \>350 cells/cmm) who have high N. gonorrhoeae incidence and are recommended by Australian guidelines to have regular, comprehensive sexual health screening. 730 participants will be enrolled and randomised 1:1 and stratified by clinical sites to receive two doses of 4CMenB vaccine or a matching placebo at 0 and 3 months by intramuscular injection. Recruitment is for 12 months and all participants will be follow-up 3-monthly for a period of 2 years. The trial aims to evaluate the efficacy of 4CMenB in the prevention of N. gonorrhoeae infection.
Trial website
https://clinicaltrials.gov/study/NCT04415424
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Professor Kate Seib, BSc(Hon),PhD
Address 0 0
Institute for Glycomics, Griffith University, Queensland, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04415424