Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05799651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-03-10
Brief Title:
Safety and Immunogenicity of Glycovax-002 Vaccine in Healthy Adults
Sponsor:
Glycovax Pharma Inc
Organization:
Glycovax Pharma Inc
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 DSMBs approval
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 DSMBs approval
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None