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Safety and Immunogenicity of Glycovax-002 Vaccine in Healthy Adults

SARS-CoV-2 Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05799651
Study type Interventional
Source Glycovax Pharma Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date April 28, 2023
Completion date August 2024
View Details
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