~67 spots leftby Feb 2028

4C-MenB Vaccine for Gonorrhea

Recruiting in Palo Alto (17 mi)
JA
Overseen byJoseph A Duncan, MD, PhD
Age: 18 - 65
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Must not be taking: Warfarin, Probenecid, Theophylline, others
Disqualifiers: Immunodeficiencies, Autoimmune disorders, Cancer, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a double-blind randomized controlled trial to test whether the group B meningitis vaccine 4 component Neisseria meningitidis serogroup B vaccine (BEXSEROTM) (4C-MenB), trade name Bexsero™), currently approved for use by the United States Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC) for protection from Neisseria meningitidis infections, also protects from Neisseria gonorrhoeae infection using controlled human experimental infection to test protection. The information the investigator learn by doing this study may also help to develop a vaccine that protects individuals from having gonorrhea infection. The study population will consist of male participants \> 18 and \< 36 years old, living in central North Carolina, in general good health without a history of 4C-MenB vaccination. Approximately 120-140 participants will be enrolled. Participants will receive 2 doses of vaccine (2 doses of 4C-MenB or 2 comparator vaccines- seasonal influenza and tetanus/diptheria booster) as intramuscular injections, and then one intraurethral challenge with Neisseria gonorrhoeae. Following the challenge, participants will cross-over and receive two doses of vaccines not received prior to challenge (2 doses of 4CMenB or the 2 comparator vaccines- seasonal influenza and tetanus/diptheria booster) All participants receive all vaccinations by the end of the study and all vaccines used in this study are licensed and FDA-approved.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop all current medications, but certain medications are not allowed with the antibiotics used in the study. You should avoid medications like warfarin, probenecid, and some others listed in the trial details.

What data supports the effectiveness of the 4C-MenB vaccine (Bexsero) for treating gonorrhea?

Research suggests that the 4C-MenB vaccine, originally designed to protect against meningitis, might also offer some protection against gonorrhea. Studies have shown that similar vaccines can reduce the risk of gonorrhea, indicating potential effectiveness for 4C-MenB in this new use.12345

Is the 4C-MenB (Bexsero) vaccine safe for humans?

The 4C-MenB (Bexsero) vaccine has been used safely in people aged 10-25 years, with safety data collected from reports in the Vaccine Adverse Event Reporting System (VAERS) between 2015 and 2018. It has been used in response to outbreaks and is recommended for those at increased risk of meningococcal disease.678910

How is the 4C-MenB vaccine different from other treatments for gonorrhea?

The 4C-MenB vaccine, originally developed to protect against meningococcal disease, is unique because it contains multiple components that trigger an immune response, potentially offering protection against gonorrhea, a condition with limited vaccine options. This approach is novel as it repurposes a vaccine designed for a different bacterial infection to address gonorrhea.6781011

Research Team

JA

Joseph A Duncan, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for healthy males aged 18-35 in central North Carolina who haven't been vaccinated against Neisseria meningitidis group B. Participants must consent to avoid sexual activity during certain phases, not have a history of severe reactions to antibiotics or vaccines, and be able to attend all study visits.

Inclusion Criteria

No history of prior Neisseria meningitidis serogroup B (MenB) vaccination
Denies current drug abuse that would interfere with study activities
I do not have a history of unusual bleeding.
See 13 more

Exclusion Criteria

Hemoglobin level < 11.0 g/dL or above ULN and deemed clinically significant by the study physician
Have donated blood or blood products within 28 days before study vaccination, plan to donate blood at any time during the study and up to 28 days after the last blood draw
Student or employee under the direct supervision of any of the study investigators
See 18 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Vaccination

Participants receive two doses of vaccines (either BEXSERO™ or control vaccines) prior to the bacterial challenge phase

4 weeks
2 visits (in-person)

Neisseria gonorrhoeae Challenge

Participants receive a suspension containing N. gonorrhoeae and are monitored for development of urethritis

1-10 days
Daily visits (in-person)

Post-Challenge Vaccination

Participants receive two doses of vaccines not received prior to the challenge (either BEXSERO™ or control vaccines)

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • 4C-MenB (Vaccine)
Trial OverviewThe trial tests if the FDA-approved Bexsero™ vaccine for meningitis B also prevents gonorrhea infection. It's a double-blind study where participants receive either the meningitis vaccine or other vaccines (flu and tetanus/diptheria), followed by an experimental challenge with gonorrhea bacteria.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Experimental armExperimental Treatment7 Interventions
All participants receive two immunizations prior to the bacterial challenge phase and two immunizations after the challenge phase. Individuals assigned to the experimental arm receive the recommended two doses of BEXSERO™ prior to bacterial challenge and control vaccines (FLULAVAL™ and TDVAX™) in the post-challenge vaccination phase. For bacterial challenge, all participants receive a suspension containing 10\^6 colony-forming units of N. gonorrhoeae strain FA1090 delivered to the anterior urethra. Participants receive 100% effective antibiotic treatment for N. gonorrhoeae strain FA1090 infection when (1) requested by the participant regardless of signs, symptoms or positive cultures, (2) urethral discharge is observed by the examining clinician or reported by the participant, or (3) 10 days afterurethral inoculation with bacterial product, regardless of infection status.
Group II: Control armExperimental Treatment7 Interventions
All participants receive two immunizations prior to the bacterial challenge phase and two immunizations after the challenge phase. Individuals assigned to the control arm receive control vaccines that have no relevance to N. gonorrhoeae infection (FLULAVAL™ and TDVAX™) prior to bacterial challenge and then receive two doses of BEXSERO™ in the post-challenge vaccination phase. For bacterial challenge, all participants receive a suspension containing 10\^6 colony-forming units of N. gonorrhoeae strain FA1090 delivered to the anterior urethra. Participants receive 100% effective antibiotic treatment for N. gonorrhoeae strain FA1090 infection when (1) requested by the participant regardless of signs, symptoms or positive cultures, (2) urethral discharge is observed by the examining clinician or reported by the participant, or (3) 10 days afterurethral inoculation with bacterial product, regardless of infection status.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Clinical and Translational Research Center (CTRC) at University of North Carolina (UNC) Hospitals and/or at UNC Global Clinical Research NorthChapel Hill, NC
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Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1588
Patients Recruited
4,364,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3361
Patients Recruited
5,516,000+

Findings from Research

The protein-based meningococcal group B vaccine Bexsero(®) may provide some protection against secondary infections, but its early effectiveness after a single dose is low, especially in young children who are at higher risk.
The estimated number needed to vaccinate (NNV) to prevent one secondary case is over 1000 in household settings, indicating that while Bexsero(®) could be useful in outbreaks, its practical application for individual cases may be limited.
Preventing secondary cases of invasive meningococcal capsular group B (MenB) disease using a recently-licensed, multi-component, protein-based vaccine (Bexsero(®)).Ladhani, SN., Cordery, R., Mandal, S., et al.[2022]
In a study of 1051 men living with HIV, those who received two doses of the 4CMenB vaccine had a 44% lower risk of contracting gonorrhea compared to those who did not receive the vaccine, indicating its effectiveness in this population.
The study, which followed participants for an average of 3.8 years, suggests that the 4CMenB vaccine may provide significant protection against gonorrhea among men who have sex with men and have a history of sexually transmitted infections.
Meningococcus B Vaccination Effectiveness Against Neisseria gonorrhoeae Infection in People Living With HIV: A Case-Control Study.Raccagni, AR., Galli, L., Spagnuolo, V., et al.[2023]
The 4CMenB vaccine, primarily designed to protect against meningococcal infections, may also provide some level of protection against Neisseria gonorrhoeae, the bacteria responsible for gonorrhea, although more research is needed to confirm this.
Understanding the immune response to gonococcal infections is complex, as the mechanisms of protection against local infections (like gonorrhea) may differ from those against systemic infections (like meningitis), highlighting the need for further studies.
Insight into Prevention of Neisseria Gonorrhoeae: A Short Review.La Fauci, V., Lo Giudice, D., Squeri, R., et al.[2022]

References

Effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhoea: a retrospective observational study. [2023]
Preventing secondary cases of invasive meningococcal capsular group B (MenB) disease using a recently-licensed, multi-component, protein-based vaccine (Bexsero(®)). [2022]
Public health impact and cost-effectiveness of gonorrhoea vaccination: an integrated transmission-dynamic health-economic modelling analysis. [2022]
Meningococcus B Vaccination Effectiveness Against Neisseria gonorrhoeae Infection in People Living With HIV: A Case-Control Study. [2023]
Insight into Prevention of Neisseria Gonorrhoeae: A Short Review. [2022]
Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. [2019]
Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018. [2023]
The role of anti-NHba antibody in bactericidal activity elicited by the meningococcal serogroup B vaccine, MenB-4C. [2018]
Safety of a meningococcal group B vaccine used in response to two university outbreaks. [2022]
[Economic evaluation of the introduction of 4CMenB (Bexsero®) in the national vaccine schedule in Spain]. [2021]
Multicomponent meningococcal serogroup B vaccine (4CMenB; Bexsero(®)): a review of its use in primary and booster vaccination. [2016]