Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

Inclusion Criteria

• Healthy man between the ages of 18 and 35 years.
• Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number).
• Willingness to provide written informed consent.
• Able and willing to attend all study visits including 6-day stay in the Clinical and Translational Research Center (CTRC) during the trial (with ability to leave the unit during the day) and follow-up visit during the week after treatment.
• Able and willing to abstain from masturbation during the 6-day stay in the CTRC.
• Able and willing to abstain from all sexual activity during the course of the study.
• Acceptable medical history by screening evaluation.
• Standard physical exam within normal limits (WNL).
• Serum creatinine WNL.
• Serum alanine transaminase (ALT) WNL.
• White blood cell (WBC), polymorphonuclear cell (PMN) and hemoglobin values WNL.
• Normal urinalysis.
• Total Complement (CH50) WNL.
• Urine negative for chlamydia, gonorrhea, trichomonas and mycoplasma.
• Negative HIV, syphilis, and Hepatitis C (HCV) test results.
• Negative Hepatitis B (HBV) core and surface antibodies or results consistent with immunization (negative HBV core antibody/positive HBV surface antibody).
• Denies history of STIs including syphilis and hepatitis B & C.
• Denies history of bleeding diathesis.
• Denies history of seizures (due to reports of seizures with ciprofloxacin).
• Denies history of cancer, except basal cell carcinoma of the skin more than 5 years ago.
• Denies history of drug abuse.
• Denies history of psychiatric disorders, except depression controlled by medication.
• Denies history of genitourinary surgery.

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.
• Psychiatric disorders that would interfere with the integrity of the data or volunteer safety.
• Unstable depression (defined as receiving either < 3 months of the same medication (and dose) or a decompensating event during the previous 3 months) or depression that, in the opinion of the investigator, will compromise the subject's ability to comply with protocol requirements.
• Heart murmur or heart disease.
• Anatomic abnormality of the urinary tract.
• Any antibiotic treatment in the past 30 days, or azithromycin in the past 60 days.
• Chemotherapy within the past year.
• Current steroid use, except for topical application.
• Allergy to penicillin, ceftriaxone or ciprofloxacin or to lidocaine.
• Treatment with medications that are contraindicated with ciprofloxacin or ceftriaxone and that cannot be withheld for the single doses given in this study.