Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)
Public ClinicalTrials.gov record NCT04870138. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Experimental Human Infection With Isogenic Mutants of Neisseria Gonorrhoeae (LptA Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04870138
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Interventions
- Azithromycin Drug
- Ceftriaxone Drug
- Ciprofloxacin Drug
- Neisseria gonorrhoeae strain FA1090 A26 Biological
- Neisseria gonorrhoeae strain FA7527 Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years to 35 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 9, 2013
- Primary completion
- Apr 27, 2015
- Completion
- Apr 27, 2015
- Last update posted
- Dec 1, 2021
2013 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of North Carolina Health Care - Infectious Diseases | Chapel Hill | North Carolina | 27514-4220 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Gonococcal Infection trials
Other public records listing Gonococcal Infection. Sorted by last update posted; newest first. Not a recommendation.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04870138, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 1, 2021 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04870138 live on ClinicalTrials.gov.