SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI (NCT05869968) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
United States140 participantsStarted 2023-03-31
Plain-language 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.
Who can participate
Age range18 Years – 89 Years
SexALL
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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:
* 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…
What they're measuring
1
mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination
Timeframe: 0-28 days after flu vaccination
2
Anti-flu antibody titers in response to vaccination