COVID-19 Vaccine Response in Chronic Respiratory Conditions

National Jewish Health

Status: Enrolling

Conditions: SARS-CoV Infection

Treatments: Biological: COVID-19 vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT05313087

21-08-054-528

Details and patient eligibility

About

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.

Full 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.

2. 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Receipt of a SARS-CoV-2 vaccination

Exclusion criteria

• None

Trial design

600 participants in 12 patient groups

Controls - who are NOT in any of the groups listed below

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Previous COVID infection

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Asthma receiving immunomodulator medications

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Asthma receiving chronic oral steroids

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Asthma - NOT receiving immunomodulator medications or chronic oral steroids

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Chronic Obstructive Pulmonary Disease (COPD

Description:

Adults

Treatment:

Biological: COVID-19 vaccine

Rheumatoid Arthritis receiving immunomodulator medications

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Rheumatoid Arthritis NOT receiving immunomodulator medications

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Interstitial lung disease

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Cancer patients receiving chemotherapy

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Bronchiectasis

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine

Cystic fibrosis

Description:

Adults and children age 5 and over.

Treatment:

Biological: COVID-19 vaccine