Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men

NCT04415424 | Active Not Recruiting Phase 3

• 2 other identifiers: HEPP2001APP1182443
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 7

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.

Conditions

Neisseria Gonorrheae Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  From Month 4 to Month 24

• 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.

  From Month 4 to Month 24

Secondary Outcomes (3)

• 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.

  From Month 4 to Month 24

• 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.

  From Month 4 to Month 24

• 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).

  From Month 4 to Month 24

Other Outcomes (6)

• To evaluate if the N. gonorrhoeae-specific enzyme-linked immunosorbent assay (ELISA) titres increase following 4CMenB vaccination.

  From Baseline through to Month 3

• To evaluate if the N. gonorrhoeae-specific serum bactericidal activity assay titres increase following 4CMenB vaccination.

  From Baseline through to Month 3

• To evaluate if the serum opsonophagocytic killing assay (OPK) titres increase following 4CMenB vaccination.

  From Baseline through to Month 3

Study Arms (2)

Treatment arm A - 4CMenB vaccine

EXPERIMENTAL

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).

Biological: 4CMenB vaccine

Treatment arm B - placebo

PLACEBO COMPARATOR

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: Placebo

Interventions

4CMenB vaccine BIOLOGICAL

A four-component meningococcal B vaccine

Also known as: Bexsero®

Treatment arm A - 4CMenB vaccine

Placebo OTHER

0.5 ml of 150 mmol sodium chloride (0.9% saline solution)

Treatment arm B - placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: High risk men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as GBM+)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Have a previous history of vaccination for meningococcal B with 4CMenB
• Have contraindications to receiving the meningococcal B vaccine which include:
• Anaphylaxis following a previous dose of any meningococcal vaccine
• Anaphylaxis following any vaccine component
• Are taking long-term (\> 4 weeks) antibiotic for prophylaxis or treatment for acne, malaria, syphilis or other bacterial condition(s)
• Have defects in, or deficiency of, complement components, including factor H, factor D or properdin deficiency
• Are taking or will receive complement inhibitors such as eculizumab (a monoclonal antibody directed against complement component C5) or ravulizumab
• Have functional or anatomical asplenia, including sickle cell disease or other haemoglobinopathies, and congenital or acquired asplenia
• Have had a haematopoietic stem cell transplant
• 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)
• Documented allergy to latex and/or kanamycin
• Have prior known meningococcal disease
• Positive pregnancy test at screening

Sponsors & Collaborators

• Kirby Institute: lead
• Griffith University: collaborator

Study Sites (7)

Western Sydney Sexual Health Centre

Parramatta, New South Wales, 2150, Australia

Location

Sydney Sexual Health Centre

Sydney, New South Wales, 2000, Australia

Location

Taylor Square Private Clinic

Sydney, New South Wales, 2010, Australia

Location

RPA Sexual Health

Sydney, New South Wales, 2050, Australia

Location

Gold Coast Sexual Health Service

Southport, Queensland, 4215, Australia

Location

Melbourne Sexual Health Centre

Carlton, Victoria, 3053, Australia

Location

Prahran Market Clinic

Melbourne, Victoria, 3181, Australia

Location

Related Publications (1)

• Seib KL, Donovan B, Thng C, Lewis DA, McNulty A, Fairley CK, Yeung B, Jin F, Fraser D, Bavinton BR, Law M, Chen MY, Chow EPF, Whiley DM, Mackie B, Jennings MP, Jennison AV, Lahra MM, Grulich AE. Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol. BMJ Open. 2024 Apr 16;14(4):e081675. doi: 10.1136/bmjopen-2023-081675.

  PMID: 38626958 DERIVED

MeSH Terms

Conditions

Gonorrhea

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Professor Kate Seib, BSc(Hon),PhD

  Institute for Glycomics, Griffith University, Queensland, Australia

  STUDY CHAIR

• Professor Basil Donovan, MBBS, MD

  The Kirby Institute, University of New South Wales Sydney, Australia

  PRINCIPAL INVESTIGATOR

• Professor Andrew Grulich, MBBS, PhD

  The Kirby Institute, University of New South Wales Sydney, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, their study clinicians and study researchers assessing the outcomes will be blinded to the treatment arm (4CMenB vaccine or placebo).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised 1:1 to receive 4CMenB vaccine or a matching placebo

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 4, 2020
• Study Start: July 8, 2021
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

AU (7)