Understanding immune responses to vaccines in people with spinal cord injuries
Biomarkers of Immune Dysfunction and Vaccine Responsiveness in People With Chronic Traumatic Spinal Cord Injury
This study looks at how people with spinal cord injuries respond to flu and COVID-19 vaccines compared to healthy people to see what affects their immunity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Manhasset, New York) |
| Trial ID | NCT05869968 on ClinicalTrials.gov |
What this trial studies
This observational research aims to investigate how individuals with spinal cord injuries (SCI) respond to vaccines for influenza and COVID-19 compared to healthy individuals. The study will measure immune responses by analyzing various types of white blood cells and the substances they produce, such as antibodies and proteins. By observing differences in vaccine responses over time, the research seeks to uncover factors that influence immunity in both uninjured individuals and those with SCI, particularly focusing on the severity and level of injury. The ultimate goal is to enhance vaccination strategies and improve infection management in these populations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-89 with a traumatic spinal cord injury who meet specific neurological and health criteria.
Not a fit: Patients without spinal cord injuries or those with conditions like cancer, autoimmune diseases, or severe pressure ulcers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vaccination strategies for individuals with spinal cord injuries, enhancing their immune responses and reducing infection risks.
How similar studies have performed: While there is limited information on similar studies specifically targeting SCI populations, research on immune responses to vaccines in other high-risk groups has shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 this trial is running
Manhasset, New York
- Northwell Health — Manhasset, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ona Bloom, PhD — Feinstein Institute for Medical Research; Northwell Health
- Study coordinator: Welmince Pello, MPH
- Email: wpello@northwell.edu
- Phone: 516-562-1331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.