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NCT05869968 | RECRUITING | Spinal Cord Injuries

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

Northwell Health

Information provided by (Responsible Party):

Then Bloom

Brief 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.

Condition or disease

Spinal Cord Injuries

Traumatic Spinal Cord Injury

Healthy Controls

Flu Vaccine

COVID-19 Vaccine

Detailed Description:

The purpose of this research study is to measure a person's immune response to a vaccine by measuring types of circulating white blood cells (WBC) and the substances they produce in blood, including antibodies, proteins, and ribonucleic acids (the body's genetic blueprint for making proteins). The research will study two populations: uninjured people and people living with spinal cord injury (SCI), who are often at increased risk of infections. We will measure and observe over time any differences in immune responses to vaccines between those groups or among people with SCI according to their injury severity or level. The overall goal of this study is to increase knowledge of immune responses to vaccination against influenza virus that causes the flu, and to the SARS-CoV-2 virus that causes COVID-19. There is currently a lack of information about what influences individual responses to vaccines and why people with SCI are at typically at increased risk of infection. Results from this study may teach us how to improve vaccination strategies and other ways to fight infections in uninjured people and in people with SCI

Study Type : OBSERVATIONAL
Estimated Enrollment : 140 participants
Official Title : Biomarkers of Immune Dysfunction and Vaccine Responsiveness in People With Chronic Traumatic Spinal Cord Injury
Actual Study Start Date : 2023-03-31
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 89 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
    • SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI

    Location Details

    NCT05869968

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, New York

    Northwell Health

    Manhasset, New York, United States, 11030