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Safety and Immunogenicity of Glycovax-002 Vaccine in Healthy Adults

NCT05799651 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-09-24

No results posted yet for this study

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

Interventions

BIOLOGICAL

Glycovax-002

Intramuscular injection of vaccine against SARS-CoV-2

Sponsors & Collaborators

  • Government of Canada

    collaborator OTHER_GOV

  • JSS Medical Research Inc.

    collaborator INDUSTRY

  • Avance Clinical Pty Ltd.

    collaborator INDUSTRY

  • Seppic

    collaborator INDUSTRY

  • Glycovax Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Kristi McLendon, MD · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05799651 on ClinicalTrials.gov