The investigators will assess the antibody, T cell and B cell responses to SARS-CoV-2vaccination before and every 3 months for 18 months after the initial vaccination orsubsequent vaccinations (boosters) in adults and children including patients with chronicmedical conditions.
HYPOTHESES
1. Patients with chronic respiratory diseases will have a lower antibody response to
SARS-CoV-2 virus after vaccination and shorter durability of the response than
control subjects without chronic disorders.
2. Patients on corticosteroids and other immunomodulator medications for chronic
medical disorders will have a lower antibody response to SARS-CoV-2 after
vaccination and shorter durability of the response than subjects with chronic
disorders who are not being treated with corticosteroids and immunomodulator
medications.
SPECIFIC AIMS
1. Enroll up to 1,000 patients receiving a SARS-CoV-2 vaccination (initial or
subsequent vaccinations) in an observational study to determine vaccine antibody
response and durability.
1. Obtain blood samples to measure antibody assess the antibody, T cell and B cell
responses to SARS-CoV-2 vaccination before and every 3 months for 18 months
after the initial vaccination or subsequent vaccinations (boosters) .
2. Categorize patients by their age, gender, race, ethnicity, underlying chronic
disease, disease severity, medical therapy and comorbidities.
3. Assess the clinical effectiveness of the vaccine to prevent COVID-19
infections.
3. Determine the clinical features and gene expression of patients who are less
responsive (have lower antibody levels and shorter duration of antibody response) to
SARS-CoV-2 vaccinations.
STUDY DESIGN Patient population - up to 1,000.
Consisting of patients in the following groups:
1. Controls - who are NOT in any of the groups listed below.
2. Previous COVID infection
3. Asthma receiving immunomodulator medications
4. Asthma receiving chronic oral steroids
5. Asthma - NOT receiving immunomodulator medications or chronic oral steroids
6. Chronic Obstructive Pulmonary Disease (COPD)
7. Rheumatoid Arthritis receiving immunomodulator medications
8. Rheumatoid Arthritis NOT receiving immunomodulator medications
9. Interstitial lung disease
10. Cancer patients receiving chemotherapy
11. Bronchiectasis
12. Cystic fibrosis
Biological: COVID-19 vaccine
assess response to vaccine
Inclusion Criteria:
- Receipt of a SARS-CoV-2 vaccination
Exclusion Criteria:
- None
National Jewish Health
Denver, Colorado, United States
Investigator: Barry Make, MD
Contact: 303-398-1993
makeb@njhealth.org
Barry Make, MD
303-398-1993
makeb@njhealth.org
Michael Wechsler, MD
303-398-1085
wechslerm@njhealth.org
Barry Make, MD, Principal Investigator
National Jewish Health