At a glance
ClinicalIndex Comparison Record- ✓Age 18–50 years at informed consent
- ✓Healthy as established by medical history, clinical examination, and laboratory assessment (intensive safety monitoring subsets); medical history and clinical examination alone for remaining participants
- ✓At risk for gonococcus infections based on sexual behavior: MSM, PrEP users, transactional sex workers, history of STI, or seeking STI services
- ✓Adequate contraception for 1 month prior and continued during study plus 1 month after (female of childbearing potential)
- ✕Any clinically significant biochemical or hematological laboratory abnormality (especially in intensive safety monitoring subsets)
- ✕Confirmed or suspected immunosuppressive/immunodeficient condition based on medical history and physical examination
- ✕History of invasive meningococcal disease
- ✕Gonococcal infection identified within 14 days prior to randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2, Observer-blind, Randomized, Placebo-controlled Multi-country Study to Assess Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
In Brief
A Phase 1 clinical trial evaluating NgG 12.5 µg investigational vaccine, NgG 25 µg investigational vaccine, and 2 other interventions for Sexually Transmitted Diseases. Completed, enrolled 1,009 participants across 23 sites in 8 countries.
Detailed 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).
Study Details
Timeline
Arms & Interventions
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
Participants received 2 doses of placebo on Day 1 and Day 61.
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
Participants received 2 doses of placebo on Day 1 and Day 61.
Interventions
2 doses of NgG 12.5 µg investigational vaccine administered intramuscularly.
2 doses of NgG 25 µg investigational vaccine administered intramuscularly.
2 doses of NgG 50 µg investigational vaccine administered intramuscularly.
2 doses of placebo administered intramuscularly.