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OpenTrials
Completed

NCT Number: NCT05313087

COVID-19 Vaccine Response in Chronic Respiratory Conditions

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.

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Key information

Conditions

SARS-CoV Infection Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

About this study

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.
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receipt of a SARS-CoV-2 vaccination

Exclusion criteria

  • None

Treatment and study plan

COVID-19 vaccine

Biological

assess response to vaccine

Primary outcomes

  1. Antibody response

    Time frame: after SARS-CoV-2 vaccinations

    quantitative spike protein antibody, binding antibody units (BAU)

Secondary outcomes

  1. Antibody change

    Time frame: Change 3 months after vaccinations

    Quantitative spike protein antibody, binding antibody units (BAU)

  2. Antibody change

    Time frame: Change 6 months after vaccinations

    Quantitative spike protein antibody, binding antibody units (BAU)

  3. Antibody change

    Time frame: Change 9 months after vaccinations

    Quantitative spike protein antibody, binding antibody units (BAU)

  4. Antibody change

    Time frame: Change 12 months after vaccinations

    Quantitative spike protein antibody, binding antibody units (BAU)

  5. Antibody change

    Time frame: Change 18 months after vaccinations

    Quantitative spike protein antibody, binding antibody units (BAU)

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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