Experimental Human Infection With Neisseria Gonorrhoeae
Status:
Completed
Trial end date:
2019-11-25
Target enrollment:
Participant gender:
Summary
This is a Phase 1, interventional, non-randomized, experimental infection model study with
healthy adult males adults (N=32) between the ages of 18-36 at study enrollment. The study is
designed to test the requirements of predicted N. gonorrhoeae virulence determinants for
gonococcal infection in the male urethra. The duration for all participants will be about 3
weeks. Study duration will be approximately about 18 months for implementation and
enrollment. The primary objectives of the present study are to: (1) compare infectivity of
different isogenic mutants with wild-type (WT) N. gonorrhoeae in noncompetitive infections
and to (2) assess relative fitness of the mutant in competitive infections initiated by
inocula containing equivalent numbers of both WT and mutant strains for mutants with WT
infectivity.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)