SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Running, not enrolling
Conditions studied: Spinal Cord Injuries, Traumatic Spinal Cord Injury, Healthy Controls, Flu Vaccine, COVID-19 Vaccine
In brief
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.
Key facts
- Study ID
- NCT05869968
- Run by
- Northwell Health
- People needed
- 140
- Starts
- 2023-03-31
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-04-03
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Northwell Health — Manhasset, New York, United States
Full record on ClinicalTrials.gov
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