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

NCT05869968 | Recruiting

• 1 other identifier: 22-0787-FIMR
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Traumatic Spinal Cord Injury; Healthy Controls; Flu Vaccine; COVID-19 Vaccine

Keywords

Chronic Spinal Cord Injury; Flu Vaccination; COVID-19 Vaccination; Immune Responsiveness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• mRNA transcript levels for genes expressed according to white blood cell type after COVID-19 vaccination

  0-28 days after COVID-19 vaccination

• Anti-COVID-19 antibody titers in response to vaccination

  0-28 days after COVID-19 vaccination

• Systemic inflammatory cytokine levels in response to vaccination

  0-28 days after vaccination

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• Cancer, chemotherapy, neutropenia
• Pregnancy or lactation
• Autoimmune disease

Sponsors & Collaborators

• Northwell Health: lead
• United States Department of Defense: collaborator
• New York State Department of Health: collaborator

Study Sites (1)

Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and a self-collected nasal swab will be collected.

MeSH Terms

Conditions

Spinal Cord Injuries; Influenza, Human

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Ona Bloom, PhD

  Feinstein Institute for Medical Research; Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Welmince Pello, MPH

CONTACT

516-562-1331; wpello@northwell.edu

Joy Cambe, MD, MPH

CONTACT

516-562-1331; jcambe@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 23, 2023
• Study Start: March 31, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (1)