Biomarkers of Immune Dysfunction and Vaccine Responsiveness in People With Chronic Traumatic Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Northwell Health
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 exclusion criteria:
- •Stage III-IV pressure ulcers
- •Cancer, chemotherapy, neutropenia
- •Pregnancy or lactation
- •No known SCI
- •Autoimmune disease
- •Pre-existing neurological disease
- •History of dementia
- •Any other condition that would compromise their ability to provide informed consent
- •Any other condition that a study physician feels would preclude participation or be contraindicated
- •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:
- •18-89 years old without traumatic SCI
- •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, uninjured control participants are required to not meet the following exclusion criteria:
- •Cancer, chemotherapy, neutropenia
- •Pregnancy or lactation
- •Autoimmune disease
- •Pre-existing neurological disease
- •History of dementia
- •Any other condition that would compromise their ability to provide informed consent
- •Any other condition that a study physician feels would preclude participation or be contraindicated
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination
Time Frame: 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
Time Frame: 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 Outcomes
- Systemic inflammatory cytokine levels in response to vaccination(0-28 days after vaccination)
- Anti-COVID-19 antibody titers in response to vaccination(0-28 days after COVID-19 vaccination)
- mRNA transcript levels for genes expressed according to white blood cell type after COVID-19 vaccination(0-28 days after COVID-19 vaccination)
Investigators
Ona Bloom
Professor
Northwell Health