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 range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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