Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age

Summary

The aim of this first time in human proof of concept (FTiH-PoC) study was to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).

Timeline

Start

2022-11-28

Primary completion

2025-05-22

Completion

2025-05-22

Outcome

Missed primary endpoint

registry Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group vs Phase 2: Placebo Group; VE 9.89 (85% CI -16.69 to 30.46) NCT05630859 ↗

registry Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group vs Phase 2: Placebo Group; VE 10.90 (85% CI -15.63 to 31.40) NCT05630859 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	generalized modules for membrane antigens (GMMA)	Vaccine	12.5 ug	Intramuscular
Subject	generalized modules for membrane antigens (GMMA)	Vaccine	25 ug	Intramuscular
Subject	generalized modules for membrane antigens (GMMA)	Vaccine	50 ug	Intramuscular

Indications