Trial Details

Not Recruiting
Basic Information
Clinical ID c2431
Identifier ISRCTN68832164
Trial Title Humoral and cellular immune REsponse to SARS-CoV-2 vaccination in adult Patients with stable inflammatOry bowel disease or autoimmuNe hepatitis treated with different immunoSuppressive regimens: observational, prospectivE, controlled, single-center study
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Immune response to COVID-19 (SARS-CoV-2 infection) vaccination in patients on immunosuppressive therapy Infections and Infestations
Interventions This study involves no intervention. The study team does not provide SARS-CoV-2 vaccination. The researchers only observe the immune response to SARS-CoV-2 vaccination. The vaccination itself is carried out through the national vaccination program. The SARS-CoV-2 vaccination is not performed at the study site. The researchers expect that the majority of patients will be vaccinated by their general practitioners. They bear no responsibility for the administration of the vaccine and any associated complications. Throughout the study, all necessary data concerning the SARS-CoV-2 vaccination are obtained from a survey. The study consists of a total of three visits in which the patients will fill out a questionnaire and a blood sample is collected for detection of antibodies against SARS-CoV-2, total immunoglobulin G levels, and various other immunological parameters. The initial blood sample also includes an examination of complete blood count and basic biochemistry to determine the activity of IBD or AIH, and an examination of the level of 25-hydroxyvitamin D, which plays an important role in immune functions. The initial visit and inclusion in the study must take place within 1 month before the start of SARS-CoV-2 vaccination, the second visit is scheduled 1 month after the end of vaccination and the third and last visit is scheduled 6 months after the end of vaccination.
Participant Information
Sponsor Charles University
City -
Country/Region Czech Republic
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2022-04-01