COVID-19 Vaccine Response in Chronic Respiratory Conditions
NCT ID: NCT05313087
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
600 participants
OBSERVATIONAL
2021-02-03
2024-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Covid-19 Vaccine Response in Elderly Subjects
NCT04760704
Analysis of the Specificity and Persistence of Nasal Immune Responses to Respiratory Viral Antigens in Immunocompromised and Healthy Cohorts
NCT07295535
COVID-19 Vaccine Reactogenicity and Immunogenicity
NCT05258708
Immune Damage and Vaccination in COPD Patients
NCT03804138
Immune Changes in Severe COVID-19 Pulmonary Infections
NCT04386395
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Controls - who are NOT in any of the groups listed below
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Previous COVID infection
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Asthma receiving immunomodulator medications
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Asthma receiving chronic oral steroids
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Asthma - NOT receiving immunomodulator medications or chronic oral steroids
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Chronic Obstructive Pulmonary Disease (COPD
Adults
COVID-19 vaccine
assess response to vaccine
Rheumatoid Arthritis receiving immunomodulator medications
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Rheumatoid Arthritis NOT receiving immunomodulator medications
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Interstitial lung disease
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Cancer patients receiving chemotherapy
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Bronchiectasis
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Cystic fibrosis
Adults and children age 5 and over.
COVID-19 vaccine
assess response to vaccine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
COVID-19 vaccine
assess response to vaccine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Jewish Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Barry Make
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barry Make, MD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Jewish Health
Denver, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-08-054-528
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.