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

Exclusion Criteria

• •Student or employee under the direct supervision of any of the study investigators
• •Any known immunodeficiencies, including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection
• •A history of prior confirmed N. meningitidis infection
• •Hemophilia or other bleeding diatheses.
• •Autoimmune disorders; mild autoimmune disorders, such as eczema, are not exclusionary and will be determined by the study physician.
• •Unstable psychiatric condition (defined as receiving either \<3 months of the same medication (and dose) or a decompensating event during the previous 3 months) or psychiatric condition that, in the opinion of the investigator, will compromise the participant's ability to comply with protocol requirements
• •Known anatomic abnormality of the urethra or urethral meatus (granular hypospadias is not exclusionary if the study physician believes that the urethral location will not interfere with inoculation catheter insertion)
• •Any immunization in 28 days prior to enrollment
• •Self-reported treatment for cancer within the past year
• •Receipt of anticoagulants (aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) are acceptable) within 14 days prior to study entry.
• •Use of any systemic immunomodulatory treatment, systemic corticosteroids, (inhaled and topical corticosteroids acceptable), investigational products, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
• •Have donated blood or blood products within 28 days before study vaccination, plan to donate blood at any time during the study and up to 28 days after the last blood draw.
• •Allergy to penicillin, cephalosporins or ciprofloxacin or to lidocaine or any component of 4C-MenB vaccine or control vaccines (flu, Influenza vaccine (FLULAVALTM) and Td, TDVAXTM), including latex (confirmed delayed contact hypersensitivity to latex is not exclusionary)
• •Treatment with medications that are contraindicated with cefixime, ceftriaxone or ciprofloxacin and that cannot be withheld for the single doses given in this study
• •Serum creatinine level \> 1.1X upper limit of normal (ULN) and deemed clinically significant by the study physician
• •Serum ALT level \> 1.25X ULN and deemed clinically significant by the study physician
• •WBC count \< 2.5 or \> 15.0 x109/L and deemed clinically significant by the study physician
• •Absolute neutrophil count (ANC) \< 1.0 x 109/L and deemed clinically significant by the study physician
• •Hemoglobin level \< 11.0 g/dL or above ULN and deemed clinically significant by the study physician
• •Urinalysis: Qualitative protein level ≥ 1+ or Red blood cell (RBC) count≥ 6/hpf
• •Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
• •Medications not permitted with cefixime or ceftriaxone:
• •Warfarin Probenecid Aspirin Diuretics such as furosemide Aminoglycoside antibiotics Chloramphenicol
• •Medications not permitted with ciprofloxacin:
• •Tizanidine Theophylline Warfarin Glyburide Cyclosporine Probenecid Phenytoin Methotrexate Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc Caffeine-containing medications Sucralfate or didanosine chewable or buffered tablets