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ACTIVE NOT RECRUITING

NCT05869968

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

Sponsor: Northwell Health

View on ClinicalTrials.gov

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.

Official title: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in People With Chronic Traumatic Spinal Cord Injury

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2023-03-31

Completion Date

2027-12-31

Last Updated

2026-04-03

Healthy Volunteers

Yes

Conditions

Spinal Cord Injuries Traumatic Spinal Cord Injury Healthy Controls Flu Vaccine COVID-19 Vaccine

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

Locations (1)

Northwell Health

Manhasset, New York, United States