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

Spinal Cord Injuries Clinical Trial

— SCIVAX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869968
• Other study ID #: 22-0787-FIMR
• Status: Recruiting
• Start date: March 31, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Northwell Health
• Contact: Welmince Pello, MPH
• Phone: 516-562-1331
• Email: wpello[@]northwell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2027
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Vaccine
• Flu Vaccine
• Healthy Controls
• Immune System Diseases
• Spinal Cord Injuries
• Traumatic Spinal Cord Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Northwell Health	Manhasset	New York

Sponsors (3)

Lead Sponsor	Collaborator
Northwell Health	New York State Department of Health, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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