140
Participants
Start Date
April 18, 2022
Primary Completion Date
February 29, 2028
Study Completion Date
February 29, 2028
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.
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.
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
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.
Meningococcal Group B Vaccine
All participants will receive 2 doses of the 4CMenB vaccine, 0.5 mL intramuscularly
Influenza Vaccine
All participants will receive the quadrivalent influenza vaccine, 0.5 mL intramuscularly.
Tetanus-diptheria Vaccine
All participants will receive the Td vaccine, 0.5 mL intramuscularly.
RECRUITING
Clinical and Translational Research Center (CTRC) at University of North Carolina (UNC) Hospitals and/or at UNC Global Clinical Research North, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of North Carolina, Chapel Hill
OTHER