COVID-19 Vaccine, Flu Vaccine, Healthy Controls, Spinal Cord Injuries, Traumatic Spinal Cord Injury
Conditions
Keywords
Chronic Spinal Cord Injury, Flu Vaccination, COVID-19 Vaccination, Immune Responsiveness
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 person's 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 body's 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
Interventions
None listed
Sponsors
Northwell Health
United States Department of Defense
New York State Department of Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
SCI Participant Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria: * 18-89 years old with traumatic SCI * initial traumatic SCI \>/=1 year from enrollment (DOD funded study) * initial traumatic SCI \<1 year from enrollment (non-DOD funded pilot study) * American Spinal Injury Association (ASIA) classification grade A-D * Neurological Injury Level C1-T10 * Demonstrate capacity to provide informed consent using the "teach back" method to verify understanding and appreciation of study objectives and procedures.
Exclusion criteria
To be eligible for prospective enrollment, SCI participants are required to not meet the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination | 0-28 days after flu vaccination | Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity. |
| Anti-flu antibody titers in response to vaccination | 0-28 days after flu vaccination | Serum samples will be used to determine antibody titers for anti-flu antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mRNA transcript levels for genes expressed according to white blood cell type after COVID-19 vaccination | 0-28 days after COVID-19 vaccination | Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity. |
| Anti-COVID-19 antibody titers in response to vaccination | 0-28 days after COVID-19 vaccination | Serum samples will be used to determine antibody titers for anti-COVID-19 antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity |
| Systemic inflammatory cytokine levels in response to vaccination | 0-28 days after vaccination | Serum samples will be used to determine systemic inflammatory cytokine levels at baseline and after flu or COVID-19 vaccination. These samples will be obtained to determine if cytokine levels are different between participant groups and within the SCI group by injury level and severity |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROna Bloom, PhD
Feinstein Institute for Medical Research; Northwell Health
Outcome results
None listed