Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae

Summary

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.

Conditions

• Gonorrhea Male

Interventions

DRUG

Cefixime

Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of clinically apparent urethritis or on the 10th study day after inoculation.

DRUG

Ceftriaxone

Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of clinically apparent urethritis or on the 10th study day after inoculation.

DRUG

Ciprofloxacin

Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the subject has a positive N. gonorrhoeae test within 1 week post initial antibiotic treatment

BIOLOGICAL

Neisseria gonorrhoeae strain FA1090

0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.

BIOLOGICAL

Meningococcal Group B Vaccine

All participants will receive 2 doses of the 4CMenB vaccine, 0.5 mL intramuscularly

BIOLOGICAL

Influenza Vaccine

All participants will receive the quadrivalent influenza vaccine, 0.5 mL intramuscularly.

BIOLOGICAL

Tetanus-diptheria Vaccine

All participants will receive the Td vaccine, 0.5 mL intramuscularly.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Joseph A Duncan, MD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-04-18

Primary Completion

2026-02-05

Completion

2026-02-05

FDA Drug

Yes

Countries

• United States

Study Locations