Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-05 @ 5:17 PM
Study NCT ID:
NCT05696067
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2023-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Corfluvec Vaccine for the Prevention of COVID-19 in Healthy Volunteers
Sponsor:
Tatyana Zubkova
Organization:
Study Overview
Official Title:
Randomized, Double-blind, Placebo-controlled Phase 1/2 Trial of Corfluvec Intranasal Vector Vaccine for the Prevention of COVID-19 in Healthy Volunteers Aged 18 to 60 Years
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The aim of the study is to investigate the safety and immunogenicity of a two-component intranasal vaccine for the prevention of COVID-19 in healthy volunteers 18-60 years old
Detailed Description:
Study include three parts. During the first part the two vaccine components will be administered separately to a small number of seronegative participants in low dose and then high dose to evaluate each component's safety. During the second part vaccine components would be administered one after another with 21 days interval to evaluate safety of the complete vaccine regimen (low dose and high dose). During the third part of the study the high dose vaccine will be administered to participants to evaluate vaccine immunogenicity. The whole study will include 200 participants. Duration of the study for each participant is about 6.5 months (no more than 194 days).
Study Oversight
Has Oversight DMC:
True
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?: