Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT05315856
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms
Sponsor:
Korea University Guro Hospital
Organization:
Study Overview
Official Title:
Different Significance of Reactogenicity in Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms: BNT162b2 mRNA Versus ChAdOx1 nCoV19 Vaccine
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity
Detailed Description:
There is a different aspect of reactogenicity between BNT162b2 and ChAdOx1 nCoV-19 vaccine. Both new platform vaccines were concerned if they would elicit more significant local or systemic reactogenicity compared to the conventional vaccines. Previous studies had reported that immune cells such as mast cells and macrophages are activated just after vaccination, and release proinflammatory cytokines such as interleukin (IL)-6 and tumor necrosis factor (TNF)-α. The post-vaccination kinetics of inflammatory cytokines would be variable by each vaccine platform, and might be associated with reactogenicity. It is an interesting issue to be investigated whether the reactogenicity following newly developed BNT162b2 and ChAdOx1 would be associated with immunogenicity and inflammatory response or not. To better clarify these uncertainties, we evaluated the change of antibody response between BNT162b2 and ChAdOx1 over three months post-vaccination, in relation to the kinetics of inflammatory cytokines and reactogenicity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: