RecruitingNCT05869968
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Biomarkers of Immune Dysfunction and Vaccine Responsiveness in People With Chronic Traumatic Spinal Cord Injury
Sponsor
Northwell Health
Enrollment
140 participants
Start Date
Mar 31, 2023
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 89 Years
Inclusion Criteria8
- -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.
- -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 Criteria17
- 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:
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05869968
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