COVID-19 Vaccine Response in Chronic Respiratory Conditions
Purpose
The investigators will 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) in adults and children including patients with chronic medical conditions.
Condition
- SARS-CoV Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Receipt of a SARS-CoV-2 vaccination
Exclusion Criteria
- None
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Controls - who are NOT in any of the groups listed below | Adults and children age 5 and over. |
|
| Previous COVID infection | Adults and children age 5 and over. |
|
| Asthma receiving immunomodulator medications | Adults and children age 5 and over. |
|
| Asthma receiving chronic oral steroids | Adults and children age 5 and over. |
|
| Asthma - NOT receiving immunomodulator medications or chronic oral steroids | Adults and children age 5 and over. |
|
| Chronic Obstructive Pulmonary Disease (COPD | Adults |
|
| Rheumatoid Arthritis receiving immunomodulator medications | Adults and children age 5 and over. |
|
| Rheumatoid Arthritis NOT receiving immunomodulator medications | Adults and children age 5 and over. |
|
| Interstitial lung disease | Adults and children age 5 and over. |
|
| Cancer patients receiving chemotherapy | Adults and children age 5 and over. |
|
| Bronchiectasis | Adults and children age 5 and over. |
|
| Cystic fibrosis | Adults and children age 5 and over. |
|
Recruiting Locations
Denver, Colorado 80206
More Details
- NCT ID
- NCT05313087
- Status
- Recruiting
- Sponsor
- National Jewish Health
Detailed Description
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