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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: 1009

Last updated 2026-06-16

Study results available
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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).

Conditions

  • Sexually Transmitted Diseases

Interventions

BIOLOGICAL

NgG 12.5 µg investigational vaccine

2 doses of NgG 12.5 µg investigational vaccine administered intramuscularly.

BIOLOGICAL

NgG 25 µg investigational vaccine

2 doses of NgG 25 µg investigational vaccine administered intramuscularly.

BIOLOGICAL

NgG 50 µg investigational vaccine

2 doses of NgG 50 µg investigational vaccine administered intramuscularly.

COMBINATION_PRODUCT

Placebo

2 doses of placebo 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

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