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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| New York State Department of Health | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with Chronic Spinal Cord Injury who receive either Flu or COVID-19 vaccine | 18-89 years old with traumatic SCI, AIS grade A-D, Neurological injury level of C1-T10 who are choosing to receive a vaccine against the flu or COVID-19 and demonstrate capacity to provide informed consent. | ||
| Uninjured Controls who receive the Flu vaccine or COVID-19 vaccine | 18-89 years old without traumatic Spinal Cord Injury (SCI) who are choosing to receive a vaccine against either the Flu or COVID-19 and demonstrate the capacity to provide informed consent. |
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| Measure | Description | Time Frame |
|---|---|---|
| mRNA transcript levels for genes expressed according to white blood cell type 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. | 0-28 days after flu vaccination |
| Anti-flu antibody titers in response to 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 | 0-28 days after flu vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| mRNA transcript levels for genes expressed according to white blood cell type 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. | 0-28 days after COVID-19 vaccination |
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Inclusion Criteria
SCI Participant Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria:
Exclusion Criteria
To be eligible for prospective enrollment, SCI participants are required to not meet the following exclusion criteria:
Uninjured Control Group:
Inclusion Criteria
Uninjured Control Participant Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria:
Exclusion Criteria
To be eligible for prospective enrollment, uninjured control participants are required to not meet the following exclusion criteria:
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Participants will be adults (ages 18-89 years old) with SCI or who are uninjured controls who are electing to receiving flu or COVID-19 vaccines to promote their health.
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| Name | Affiliation | Role |
|---|---|---|
| Ona Bloom, PhD | Feinstein Institute for Medical Research; Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health | Manhasset | New York | 11030 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Blood and a self-collected nasal swab will be collected.
| Anti-COVID-19 antibody titers in response to 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 | 0-28 days after COVID-19 vaccination |
| Systemic inflammatory cytokine levels in response to 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 | 0-28 days after vaccination |
| D014947 | Wounds and Injuries |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |