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Vaccine
4C-MenB Vaccine for Gonorrhea
Phase 2
Recruiting
Led By Joseph A Duncan, MD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Denies history of bleeding diathesis
Assigned male at birth and now ≥ 18 and < 36 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 1 and 10 days after n. gonorrhoeae inoculation (between study day 58 and study day 123)
Awards & highlights
Study Summary
This trial tests whether the group B meningitis vaccine protects from Neisseria gonorrhoeae infection. Approximately 120-140 participants will be enrolled and receive 2 doses of vaccine.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include typical vaccine reactions like soreness at injection site, fever, fatigue, headache, and muscle pain. There may also be specific risks associated with the experimental urethral exposure to gonorrhea which will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have a history of unusual bleeding.
Select...
I am a man between 18 and 35 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between 1 and 10 days after n. gonorrhoeae inoculation (between study day 58 and study day 123)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 1 and 10 days after n. gonorrhoeae inoculation (between study day 58 and study day 123)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Infectivity of N. gonorrhoeae inoculum
Secondary outcome measures
Proportion of participants that develop macroscopic urethritis
Proportion of participants that develop symptomatic microscopic urethritis
Time to develop macroscopic urethritis
Side effects data
From 2020 Phase 4 trial • 11 Patients • NCT0409488373%
injection site (left deltoid) pain
36%
Injection site (left deltoid) tenderness
27%
Fatigue
18%
Injection site (left deltoid) erythema
18%
Subjective fever
18%
Nausea
18%
Headache
18%
Injection site (left deltoid) induration
9%
cough and nasal congestion
9%
upper respiratory tract infection
9%
Gastroesophageal reflux
9%
Injection site (left deltoid) swelling
9%
Abdominal pain
9%
chills
9%
lightheadedness
9%
pharyngitis
9%
wisdom teeth extraction
9%
flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
4CMenB Vaccine
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza Vaccine
2010
Completed Phase 4
~6900
Meningococcal Group B Vaccine
2021
Completed Phase 4
~70
Cefixime
2012
Completed Phase 4
~960
Ceftriaxone
2019
Completed Phase 4
~5020
Ciprofloxacin
2014
Completed Phase 4
~8080
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,476 Total Patients Enrolled
5 Trials studying Gonorrhea
1,913 Patients Enrolled for Gonorrhea
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,329 Total Patients Enrolled
28 Trials studying Gonorrhea
48,354 Patients Enrolled for Gonorrhea
Joseph A Duncan, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Gonorrhea
11 Patients Enrolled for Gonorrhea
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder, such as HIV or chronic granulomatous disease.I am not on medications that can't be mixed with certain antibiotics.I haven't taken any blood thinners except aspirin or NSAIDs in the last 14 days.I have been treated for cancer within the last year.I haven't taken any immune system affecting drugs or investigational products in the last 45 days.I do not have a history of unusual bleeding.I have not had any cancer except possibly skin cancer more than 5 years ago.I am a man between 18 and 35 years old.I have not had surgery on my penis, urethra, prostate, or testicles, except for varicocele repair or vasectomy over a year ago.I have had a confirmed N. meningitidis infection before.I have a urethra abnormality but it doesn't affect catheter use.I have a bleeding disorder such as hemophilia.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental arm
- Group 2: Control arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants has this research project attracted thus far?
"Indeed, the records on clinicaltrials.gov indicate that recruitment is still ongoing for this medical trial which had its inception on April 18th 2022 and has since been updated as recently as May 19th 2022. The current goal of the study is to acquire 140 participants from a single location."
Answered by AI
Is my profile fitting of the criteria for participation in this research endeavor?
"The prerequisites for this medical survey are a confirmed diagnosis of gonorrhea and an age between 18 to 35 years. At present, 140 subjects are being accepted into the study."
Answered by AI
Does this experiment currently accept participants?
"According to clinicaltrials.gov, this trial is accepting participants and has been available for enrollment since April 18th 2022. The record was recently renewed on May 19th of the same year."
Answered by AI
Are those aged over 40 being included in the current trial?
"This trial requires participants to be between 18 and 35 years old."
Answered by AI
Has the Food and Drug Administration certified Meningococcal Group B Vaccine as safe?
"There is empirical evidence suggesting the safety of Meningococcal Group B Vaccine, so it was assigned a score of 2. However, no clinical data exists to support its effectiveness as this is only in Phase 2 trials."
Answered by AI
Who else is applying?
What site did they apply to?
Clinical and Translational Research Center (CTRC) at University of North Carolina (UNC) Hospitals and/or at UNC Global Clinical Research North
What portion of applicants met pre-screening criteria?
Did not meet criteria
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