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

Active Not RecruitingN/A

Sponsor: Northwell Health

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

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 89 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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

Locations (1)

Manhasset, New York, United States