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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; COVID-19 Vaccine; Traumatic Spinal Cord Injury; Healthy Controls; Flu 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
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Welmince Pello, MPH; Phone Number: 516-562-1331; Email: wpello@northwell.edu
• Study Contact Backup: Name: Joy Cambe, MD, MPH; Phone Number: 516-562-1331; Email: jcambe@northwell.edu

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Recruiting
      • Northwell Health
      • Contact: Ona Bloom, PhD; Phone Number: 516-562-3839; Email: obloom@northwell.edu
      • Contact: Welmi Pello, MPH; Phone Number: 516-562-1331; Email: wpello@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be adults (ages 18-89 years old) with SCI or who are uninjured controls who are electing to receiving flu or COVID-19 vaccines to promote their health.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRNA transcript levels for genes expressed according to white blood cell type 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.	0-28 days after flu vaccination
Anti-flu antibody titers in response to 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	0-28 days after flu vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRNA transcript levels for genes expressed according to white blood cell type 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.	0-28 days after COVID-19 vaccination
Anti-COVID-19 antibody titers in response to 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	0-28 days after COVID-19 vaccination
Systemic inflammatory cytokine levels in response to 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	0-28 days after vaccination

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: United States Department of Defense; New York State Department of Health
• Investigators: Principal Investigator: Ona Bloom, PhD, Feinstein Institute for Medical Research; Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19 Vaccination; Chronic Spinal Cord Injury; Flu Vaccination; Immune Responsiveness
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Trauma, Nervous System; Spinal Cord Diseases; COVID-19; Wounds and Injuries; Spinal Cord Injuries; Immune System Diseases
• Other Study ID Numbers: 22-0787-FIMR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No