Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04415424
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-25
First Post:
2020-05-19
Brief Title:
Efficacy Study of 4CMenB Bexsero to Prevent Gonorrhoea Infection in Gay and Bisexual Men
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official 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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GoGoVax
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 infectionThe 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 200copiesml and a cluster of differentiation 4 CD4 count 350 cellscmm 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 11 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
Detailed Description:
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 infectionThe target population for this trial is GBM either HIV-negative and on PrEP or HIV-positive who had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months a key characteristic associated with greater gonorrhoea risk This population has the highest known gonococcal incidence and are recommended under Australian guidelines to attend clinics 3-monthly for comprehensive sexual health screening including Nuclei acid amplification test NAAT-based screening of urine and pharyngeal and anal specimens for N gonorrhoeae infection 730 participants will be enrolled and randomised 11 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 will occur over a 12-month period and all participants will be followed up 3-monthly over a period of 2 years Participants their study clinicians and study researchers assessing the outcomes will be blinded to the treatment arm vaccine or placebo Participants will be required to attend approximately 10 study visits Participants may attend additional visits if they have been diagnosed with gonorrhoea infection symptomatic or asymptomatic or have a postitive gonorrhoea NAAT test when they return for test of cure Potentially eligible individuals will be screened within 14 days of baseline the visit when the first dose of study treatment is administered Randomisation can be conducted any time between screening and baseline Screening randomisation and baseline can occur on the same day if the required HIV results and drug kit containing 4CMenB or placebo are available for a participant in the clinic At screening study clinicians will conduct the informed consent process with a participant and the informed consent will be signed by both the study clinician and the participant Eligibility criteria will be checked and a review of medical history including vaccination history for 4CMenB prior known meningococcal disease recent history of sexually transmitted infections STIs history of taking PrEP for HIV negative individuals as well as antibiotic use in the last 3 months will be conducted Routine blood urine and swabs will be collected and urine pregnancy test will be performed in participants with child-bearing potential Symptoms of urethritis proctitis epididymitis and cervicitisvaginitis will be documented At randomisation which can occur anytime within screening an baseline participants will be randomised to receive either the 4CMenB vaccine or the placebo At the baseline visit research blood specimen and an oral mucosal exudate swab for immune responses testing will be collected before the administration of the first dose of the study treatment A 10-minute study questionnaire will be completed by the participants Participants will return to their study site 3 months after the first dose of study treatment to receive the second dose Prior to the treatment administration urine pregnancy test in participants with child-bearing potential will be conducted Symptoms of urethritis proctitis epididymitis and cervicitisvaginitis will be documented History of antibiotic use in the last 3 months will also be collected If a participant has tested positive for gonorrhoea infection routinely collected culture isolates and NAAT samples will be stored in a study research laboratory for phenotypic antimicrobial resistance AMR testing and genotyping Routine blood urine and swabs will also be collected Adverse events and serious adverse events SAEs will be recorded but only SAEs will be entered into the study electronic data capture system and reported to the Sponsor in real time Three-monthly visits will be conducted over a period of 2 years The study aims to evaluate the efficacy of 4CMenB in the prevention of N gonorrhoeae infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| APP1182443 | OTHER_GRANT | National Health and Medical Research Council Australia | None |