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

PHASE2RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

April 18, 2022

Primary Completion Date

February 29, 2028

Study Completion Date

February 29, 2028

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.

Trial Locations (1)

27599-7215

RECRUITING

Clinical and Translational Research Center (CTRC) at University of North Carolina (UNC) Hospitals and/or at UNC Global Clinical Research North, Chapel Hill

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

University of North Carolina, Chapel Hill

OTHER