Spinal Cord InjuriesSCIVAXNCT05869968
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
An observational study of Spinal Cord Injuries and Traumatic Spinal Cord Injury, run by Northwell Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Traumatic Spinal Cord Injury, Healthy Controls
- Type of treatment
- Vaccines
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- Demonstrate capacity to provide informed consent using the "teach back" method to verify understanding and appreciation of study objectives and procedures.
- 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.
Who cannot join
- 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
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- 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:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- 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
- Medical subject headings
- Spinal Cord Injuries, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 0-28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start31 Mar 2023
- Primary completion30 Sep 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, New York State Department of Health
- Responsible party
- Principal investigator, Ona Bloom, Northwell Health
- Investigators
- Ona Bloom, PhD, Principal investigator, Feinstein Institute for Medical Research; Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869968
- Sponsor's protocol ID
- 22-0787-FIMR
- Acronym
- SCIVAX
- Status last verified
- Mar 2026
- First submitted
- 10 May 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Immune Dysfunction and Vaccine Responsiveness in People With Chronic Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05869968
- Acronym / sponsor ID
- SCIVAX / 22-0787-FIMR
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- United States Department of Defense, New York State Department of Health
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination
Time frame: 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
Time frame: 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
3 secondary outcomes
mRNA transcript levels for genes expressed according to white blood cell type after COVID-19 vaccination
Time frame: 0-28 days after COVID-19 vaccination
Anti-COVID-19 antibody titers in response to vaccination
Time frame: 0-28 days after COVID-19 vaccination
Systemic inflammatory cytokine levels in response to vaccination
Time frame: 0-28 days after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ona Bloom, PhD principal investigator
Feinstein Institute for Medical Research; Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Traumatic Spinal Cord Injury, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination (time frame: 0-28 days after flu vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.