Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869968
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-05-10
Brief Title:
SCIVAX Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Biomarkers of Immune Dysfunction and Vaccine Responsiveness in People With Chronic Traumatic Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2024-05
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:
SCIVAX
Brief Summary:
The purpose of this observational research study is to better understand immune responses to vaccines against viruses influenza or SARS-CoV2 The goal is to determine any differences in immune responses to vaccines in uninjured people and in people living with spinal cord injuries who are typically at increased risk of infections
Detailed Description:
The purpose of this research study is to measure a persons immune response to a vaccine by measuring types of circulating white blood cells WBC and the substances they produce in blood including antibodies proteins and ribonucleic acids the bodys genetic blueprint for making proteins
The research will study two populations uninjured people and people living with spinal cord injury SCI who are often at increased risk of infections We will measure and observe over time any differences in immune responses to vaccines between those groups or among people with SCI according to their injury severity or level
The overall goal of this study is to increase knowledge of immune responses to vaccination against influenza virus that causes the flu and to the SARS-CoV-2 virus that causes COVID-19 There is currently a lack of information about what influences individual responses to vaccines and why people with SCI are at typically at increased risk of infection Results from this study may teach us how to improve vaccination strategies and other ways to fight infections in uninjured people and in people with SCI
The research will study two populations uninjured people and people living with spinal cord injury SCI who are often at increased risk of infections We will measure and observe over time any differences in immune responses to vaccines between those groups or among people with SCI according to their injury severity or level
The overall goal of this study is to increase knowledge of immune responses to vaccination against influenza virus that causes the flu and to the SARS-CoV-2 virus that causes COVID-19 There is currently a lack of information about what influences individual responses to vaccines and why people with SCI are at typically at increased risk of infection Results from this study may teach us how to improve vaccination strategies and other ways to fight infections in uninjured people and in people with SCI
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