The purpose of this observational research study is to better understand immune responsesto vaccines against viruses (influenza or SARS-CoV2). The goal is to determine anydifferences in immune responses to vaccines in uninjured people and in people living withspinal cord injuries, who are typically at increased risk of infections.
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
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
Northwell Health
Manhasset, New York, United States
Investigator: Ona Bloom, PhD
Contact: 516-562-3839
obloom@northwell.edu
Welmince Pello, MPH
516-562-1331
wpello@northwell.edu
Joy Cambe, MD, MPH
516-562-1331
jcambe@northwell.edu
Ona Bloom, PhD, Principal Investigator
Feinstein Institute for Medical Research; Northwell Health