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

HYPOTHESESPatients 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 AIMSEnroll 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.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:Controls - who are NOT in any of the groups listed below.Previous COVID infectionAsthma receiving immunomodulator medicationsAsthma receiving chronic oral steroidsAsthma - NOT receiving immunomodulator medications or chronic oral steroidsChronic Obstructive Pulmonary Disease (COPD)Rheumatoid Arthritis receiving immunomodulator medicationsRheumatoid Arthritis NOT receiving immunomodulator medicationsInterstitial lung diseaseCancer patients receiving chemotherapyBronchiectasisCystic fibrosis.

Medienart:	Klinische Studie

Erscheinungsjahr:	2022
Erschienen:	2022

Enthalten in:	ClinicalTrials.gov - (2022) vom: 06. Apr. Zur Gesamtaufnahme - year:2022

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Medical Condition: SARS-CoV Infection Recruitment Status: Recruiting Severe Acute Respiratory Syndrome Study Type: Observational

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: April 6, 2022, Last downloaded: ClinicalTrials.gov processed this data on April 18, 2022, Last updated: April 20, 2022

Study ID:	NCT05313087 21-08-054-528
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PPN (Katalog-ID):	CTG008315728