NCT05799651

Safety and Immunogenicity of Glycovax-002 Vaccine in Healthy Adults

A Randomised, Double-Blind, Dose-Escalation Phase I Study in Healthy Adults to Assess the Safety, Tolerability and Immunogenicity of Glycovax-002, a Novel Vaccine Candidate Against COVID-19

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Glycovax Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Glycovax Pharma has developed a glycoconjugate vaccine candidate called Glycovax-002 to fight the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the origin of COVID-19. The aim of the study is to assess the safety, reactogenicity and immunogenicity of Glycovax-002 in humans. The study is a phase I, placebo-controlled, dose-escalation study conducted in 36 healthy females and males aged between 18 and 55 years old. The vaccine will be administered three times with a two-week time interval between each dose. Dose escalation is conducted in three steps. At each step, 9 participants receiving the vaccine will be randomized with 3 participants receiving placebo (normal saline). Progression to next step is conditional to a DSMB's approval.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	Glycovax-002	Intramuscular injection of vaccine against SARS-CoV-2

Timeline

• Start date: 2023-04-28
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2023-04-05
• Last updated: 2024-09-24

Locations

1 site across 1 country: Australia