Experimental Human Infection With Neisseria Gonorrhoeae

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.

Timeline

Start

2017-04-23

Primary completion

2019-11-25

Completion

2019-11-25

Publications

• Waltmann A, Balthazar JT, Begum AA, Hua N, Jerse AE, Shafer WM, Hobbs MM, Duncan JA. Experimental genital tract infection demonstrates Neisseria gonorrhoeae MtrCDE efflux pump is not required for in vivo human infection and identifies gonococcal colonization bottleneck. PLoS Pathog. 2024 Sep 25;20(9):e1012578. doi: 10.1371/journal.ppat.1012578. eCollection 2024 Sep.
• Waltmann A, Balthazar JT, Begum AA, Hua N, Jerse AE, Shafer WM; UNC-Global Clinical Trials Unit/DMID 09-0106 Study Team; Hobbs MM, Duncan JA. Neisseria gonorrhoeae MtrCDE Efflux Pump During In Vivo Experimental Genital Tract Infection in Men and Mice Reveals the Presence of Within-Host Colonization Bottleneck. medRxiv [Preprint]. 2023 Jun 29:2023.06.23.23291824. doi: 10.1101/2023.06.23.23291824.

Drugs

Indications