Immuneresponse and clinical efficacy after SARS-CoV-2 Vaccination in immunodefficient patients or those undergoing immunosuppresive therapy (COVID-19)

Phase 1

• Conditions: Vaccination against SARS-CoV-2 in immunocompromised patients; MedDRA version: 23.0Level: LLTClassification code 10084462Term: SARS-CoV-2 vaccinationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000291-11-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-11
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Male and female subjects will be eligible for participation in this study if they:
•Are =18 years on the day of screening
•Have a disease that is associated with a well characterized immunodeficiency (study population)
•Treated with an immunosuppressive therapy (study population)
•Have an immune-mediated disease without an immunosuppressive therapy, e.g. IBD patients solely with 5-ASA treatment (study population)
•Are clinically healthy and not vaccinated with a SARS-CoV-2 vaccine (control group, age and sex-matched)
•Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

Are not willing to get SARS-CoV-2 Vaccination

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified