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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

Must not have

Any known immunodeficiencies, including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection

Treatment with medications that are contraindicated with cefixime, ceftriaxone or ciprofloxacin and that cannot be withheld for the single doses given in this study

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

No Placebo-Only Group

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.

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.

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 below

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I do not have a history of unusual bleeding.

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I am a man between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an immune system disorder, such as HIV or chronic granulomatous disease.

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I am not on medications that can't be mixed with certain antibiotics.

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I have been treated for cancer within the last year.

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I haven't taken any immune system affecting drugs or investigational products in the last 45 days.

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I have had a confirmed N. meningitidis infection before.

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I have a bleeding disorder such as hemophilia.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 1 and 10 days after n. gonorrhoeae inoculation (between study day 58 and study day 123) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infectivity of N. gonorrhoeae inoculum

Secondary study objectives

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 • NCT04094883

73%

injection site (left deltoid) pain

36%

Injection site (left deltoid) tenderness

27%

Fatigue

18%

Injection site (left deltoid) induration

18%

Nausea

18%

Injection site (left deltoid) erythema

18%

Subjective fever

18%

Headache

Injection site (left deltoid) swelling

chills

Abdominal pain

Gastroesophageal reflux

lightheadedness

flushing

pharyngitis

cough and nasal congestion

upper respiratory tract infection

wisdom teeth extraction

100%

80%

60%

40%

20%

Study treatment Arm

4CMenB Vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Meningococcal Group B Vaccine

2021

Completed Phase 4

~70

Cefixime

2012

Completed Phase 4

~960