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Trial details imported from ClinicalTrials.gov

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




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

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
Other interventions - 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).


Other interventions: 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
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. - Detection of the first instance of N. gonorrhoeae infection in a urine sample or on a swab taken from the urethra, anorectum, oropharynx or vagina, as determined by nucleic acid amplification (NAAT) testing.
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. - To compare the overall incidence of all episodes of N. gonorrhoeae infection diagnosed during the study period between the vaccine and placebo arms, allowing multiple diagnoses of N. gonorrhoeae infection occurred in the same individuals at different time points.
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. - Symptomatic N. gonorrhoeae infection - first instance of the detection of N. gonorrhoeae infection in a urine sample or on a swab taken from the urethra, anorectum or vagina at a study visit when a participant also reports any symptoms at the relevant anatomic site.
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 or vagina. - Asymptomatic N. gonorrhoeae infection - first instance of the detection of N. gonorrhoeae infection in a urine sample or on a swab taken from the urethra, anorectum or vagina at a study visit when a participant reports no symptoms at the relevant anatomic site.
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). - Strain specific (by whole genome sequence or antimicrobial resistance phenotype) - first instance of the detection of N. gonorrhoeae infection in a urine sample or on a swab taken from the urethra, anorectum, oropharynx or vagina, at a study visit.
Timepoint [3] 0 0
From Month 4 to Month 24

Eligibility
Key inclusion criteria
1. Between 18 to = 40 years of age

2. Men (cis and trans), trans women and non-binary people who have had sex with men in
the last 6 months

3. Diagnosis of gonorrhoea or infectious syphilis in the last 12 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 100 days of screening) and
taking HIV PrEP 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
40 Years
Gender
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 (> 2 weeks) antibiotic for prophylaxis or treatment for acne,
malaria, syphilis or other bacterial condition(s)

5. Are taking complement inhibitors such as eculizumab or ravulizumab

6. 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)

7. Documented allergy to latex and/or kanamycin

8. Have prior known meningococcal disease

9. 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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Gold Coast Sexual Health Service - Southport
Recruitment hospital [4] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment postcode(s) [1] 0 0
2150 - Parramatta
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
3053 - Carlton

Funding & Sponsors
Primary sponsor type
Other
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 18-40 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/show/NCT04415424
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Associate 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
Associate Professor Kate Seib, BSc(Hon),PhD
Address 0 0
Country 0 0
Phone 0 0
+617 55527453
Fax 0 0
Email 0 0
k.seib@griffith.edu.au
Contact person for scientific queries

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