COVID-19 Vaccine Response in Chronic Respiratory Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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HYPOTHESES 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. 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 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. 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) . Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities. 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: Controls - who are NOT in any of the groups listed below. Previous COVID infection Asthma receiving immunomodulator medications Asthma receiving chronic oral steroids Asthma - NOT receiving immunomodulator medications or chronic oral steroids Chronic Obstructive Pulmonary Disease (COPD) Rheumatoid Arthritis receiving immunomodulator medications Rheumatoid Arthritis NOT receiving immunomodulator medications Interstitial lung disease Cancer patients receiving chemotherapy Bronchiectasis Cystic fibrosis

Official Title
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COVID-19 Vaccine Response and Durability In Patients With Chronic Respiratory and Medical Disorders

Conditions
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SARS-CoV Infection

Intervention / Treatment
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* Biological: COVID-19 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receipt of a SARS-CoV-2 vaccination Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls - who are NOT in any of the groups listed below<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Previous COVID infection<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Asthma receiving immunomodulator medications<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Asthma receiving chronic oral steroids<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Asthma - NOT receiving immunomodulator medications or chronic oral steroids<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Chronic Obstructive Pulmonary Disease (COPD<br>Adults | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Rheumatoid Arthritis receiving immunomodulator medications<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Rheumatoid Arthritis NOT receiving immunomodulator medications<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Interstitial lung disease<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Cancer patients receiving chemotherapy<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Bronchiectasis<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|
| Cystic fibrosis<br>Adults and children age 5 and over. | Biological: COVID-19 vaccine<br>* assess response to vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response | quantitative spike protein antibody, binding antibody units (BAU) | after SARS-CoV-2 vaccinations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) | Change 3 months after vaccinations | 
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) | Change 6 months after vaccinations | 
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) | Change 9 months after vaccinations | 
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) | Change 12 months after vaccinations | 
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) | Change 18 months after vaccinations |