Image

COVID-19 Vaccine Response in Chronic Respiratory Conditions

COVID-19 Vaccine Response in Chronic Respiratory Conditions

Non Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.
  2. 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) .
  3. Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities.
  4. Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections.
  5. 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

Eligibility

Inclusion Criteria:

  • Receipt of a SARS-CoV-2 vaccination

Exclusion Criteria:

  • None

Study details
    SARS-CoV Infection

NCT05313087

National Jewish Health

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.