Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial) (NCT04870138) | Clinical Trial Compass
CompletedPhase 1
Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)
United States16 participantsStarted 2013-03-10
Plain-language summary
This is a Phase 1, interventional, non-randomized, experimental infection model study in healthy adult males (N=up to 25) between the ages of 18-35 at study enrollment. The study is designed to test the requirements of predicted N. gonorrhoeae virulence determinants for gonococcal infection in the male urethra through infection with engineered mutants of N. gonorrhoeae. We predict that mutations abolishing expression of N. gonorrhoeae virulence determinants will eliminate or significantly reduce gonococcal infectivity or the ability to induce inflammation in an infected individual, thus identifying potential vaccine candidates. Study duration will be 1 year, and the duration for all participants will be about 3 weeks. The primary objective of the study is to compare the ability of different engineered mutants of Neisseria gonorrhoeae to cause a clinical infection (signs or symptoms of urethritis such as discomfort during urination, urethral discharge, etc.) in the male urethra.
Who can participate
Age range18 Years – 35 Years
SexMALE
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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).
Exclusion criteria
✕. Student or employee under the direct supervision of any of the study investigators.
What they're measuring
1
The Proportion of Participants That Become Infected With Individual N. Gonorrhoeae Strains in Non-competitive Infections
Timeframe: Day of infection, any day between Day 1 and Day 5
2
The Proportion of Participants That Become Infected With Mixed Inoculum
Timeframe: Day of infection, any day between Day 1 and Day 5
3
The Proportion of Wild Type (WT) Organisms Recovered From Urine and Urethral Swab Specimens From Individual Subjects Infected With Mixed Inoculum
Timeframe: Baseline (Day 0) and the day of infection (any day between Day 1 and Day 5)
Trial details
NCT IDNCT04870138
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. 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.