SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI

Launched by NORTHWELL HEALTH · May 19, 2023

Keywords

ClinConnect Summary

The SCIVAX clinical trial is looking to understand how people with spinal cord injuries (SCI) respond to vaccines, specifically those for the flu and COVID-19. Researchers want to see if there are differences in immune responses between healthy individuals and those with SCI, as people with these injuries may be at a higher risk for infections. This study is open to individuals aged 18 to 89, including both those with SCI and healthy participants without any spinal injuries.

To participate, individuals with a spinal cord injury must have had their injury for at least a year, be able to understand the study details, and meet specific health criteria. Healthy volunteers can also join if they are without any spinal injuries and meet similar health guidelines. Throughout the trial, participants will be asked questions about their health and their responses to vaccines will be monitored. This research aims to improve our understanding of vaccine effectiveness in different populations, which could help in making better healthcare decisions for people with spinal cord injuries. If you're interested in learning more or think you might qualify, please reach out to the study team for further details.

Gender

ALL

Eligibility 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