COVID-19 Vaccine Response in Chronic Respiratory Conditions
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
HYPOTHESES
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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.
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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
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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.
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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) .
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Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities.
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Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections.
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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:
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Controls - who are NOT in any of the groups listed below.
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Previous COVID infection
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Asthma receiving immunomodulator medications
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Asthma receiving chronic oral steroids
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Asthma - NOT receiving immunomodulator medications or chronic oral steroids
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Chronic Obstructive Pulmonary Disease (COPD)
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Rheumatoid Arthritis receiving immunomodulator medications
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Rheumatoid Arthritis NOT receiving immunomodulator medications
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Interstitial lung disease
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Cancer patients receiving chemotherapy
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Bronchiectasis
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Cystic fibrosis
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Controls - who are NOT in any of the groups listed below Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Previous COVID infection Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Asthma receiving immunomodulator medications Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Asthma receiving chronic oral steroids Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Asthma - NOT receiving immunomodulator medications or chronic oral steroids Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Chronic Obstructive Pulmonary Disease (COPD Adults |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Rheumatoid Arthritis receiving immunomodulator medications Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Rheumatoid Arthritis NOT receiving immunomodulator medications Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Interstitial lung disease Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Cancer patients receiving chemotherapy Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Bronchiectasis Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
| Cystic fibrosis Adults and children age 5 and over. |
Biological: COVID-19 vaccine
assess response to vaccine
|
Outcome Measures
Primary Outcome Measures
- Antibody response [after SARS-CoV-2 vaccinations]
quantitative spike protein antibody, binding antibody units (BAU)
Secondary Outcome Measures
- Antibody change [Change 3 months after vaccinations]
Quantitative spike protein antibody, binding antibody units (BAU)
- Antibody change [Change 6 months after vaccinations]
Quantitative spike protein antibody, binding antibody units (BAU)
- Antibody change [Change 9 months after vaccinations]
Quantitative spike protein antibody, binding antibody units (BAU)
- Antibody change [Change 12 months after vaccinations]
Quantitative spike protein antibody, binding antibody units (BAU)
- Antibody change [Change 18 months after vaccinations]
Quantitative spike protein antibody, binding antibody units (BAU)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Receipt of a SARS-CoV-2 vaccination
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Jewish Health | Denver | Colorado | United States | 80206 |
Sponsors and Collaborators
- National Jewish Health
Investigators
- Principal Investigator: Barry Make, MD, National Jewish Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-08-054-528