Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)
Status:
Completed
Trial end date:
2015-04-28
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)