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

Sponsor

Northwell Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05869968

Collaborator

United States Department of Defense (U.S. Fed), New York State Department of Health (Other)

140

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Individuals with Chronic Spinal Cord Injury who receive either Flu or COVID-19 vaccine 18-89 years old with traumatic SCI, AIS grade A-D, Neurological injury level of C1-T10 who are choosing to receive a vaccine against the flu or COVID-19 and demonstrate capacity to provide informed consent.
Uninjured Controls who receive the Flu vaccine or COVID-19 vaccine 18-89 years old without traumatic Spinal Cord Injury (SCI) who are choosing to receive a vaccine against either the Flu or COVID-19 and demonstrate the capacity to provide informed consent.

Outcome Measures

Primary Outcome Measures

mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination [0-28 days after flu vaccination]
Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity.
Anti-flu antibody titers in response to vaccination [0-28 days after flu vaccination]
Serum samples will be used to determine antibody titers for anti-flu antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity

Secondary Outcome Measures

mRNA transcript levels for genes expressed according to white blood cell type after COVID-19 vaccination [0-28 days after COVID-19 vaccination]
Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity.
Anti-COVID-19 antibody titers in response to vaccination [0-28 days after COVID-19 vaccination]
Serum samples will be used to determine antibody titers for anti-COVID-19 antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity
Systemic inflammatory cytokine levels in response to vaccination [0-28 days after vaccination]
Serum samples will be used to determine systemic inflammatory cytokine levels at baseline and after flu or COVID-19 vaccination. These samples will be obtained to determine if cytokine levels are different between participant groups and within the SCI group by injury level and severity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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