COVID-19 Vaccine Response in Chronic Respiratory Conditions

SARS-CoV Infection Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

• NCT number: NCT05313087
• Study type: Observational
• Source: National Jewish Health
• Contact: Barry Make, MD
• Phone: 303-398-1993
• Email: makeb@njhealth.org
• Status: Recruiting
• Start date: February 3, 2021
• Completion date: December 30, 2024