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

NCT05630859 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1004

Last updated 2025-08-07

No results posted yet for this study

Summary

The aim of this first time in human proof of concept (FTiH-PoC) study is 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).

Conditions

  • Sexually Transmitted Diseases

Interventions

BIOLOGICAL

NgG low dose investigational vaccine

Two doses of NgG low dose investigational vaccine, administered intramuscularly.

BIOLOGICAL

NgG medium dose investigational vaccine

Two doses of NgG medium dose investigational vaccine, administered intramuscularly.

BIOLOGICAL

NgG high dose investigational vaccine

Two doses of NgG high dose investigational vaccine, administered intramuscularly.

BIOLOGICAL

Placebo

Two doses of placebo, administered intramuscularly.

BIOLOGICAL

NgG HTD investigational vaccine

Two doses of NgG HTD investigational vaccine, administered intramuscularly.

BIOLOGICAL

NgG below HTD investigational vaccine

Two doses of NgG below HTD investigational vaccine, administered intramuscularly.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2025-05-22
Completion
2025-05-22
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • France
  • Germany
  • Philippines
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05630859 on ClinicalTrials.gov