Response to SARS-CoV-2 (COVID-19) vaccines in patients receiving B-cell modulating antibodies for renal immune disease

• Conditions: U07.1; COVID-19, virus identified

• Registration Number: DRKS00027049
• Lead Sponsor: Medizinische Klinik IV, Universitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-09-30
• Study Start: 2021-10-29
• Results First Posted: 2022-09-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Age > 18 years
- Diagnosis of renal immunological disease
- Previous or ongoing antibody treatment with Rituximab
- Full vaccination with either mRNA-based (BNT162b2, mRNA-1273), or Vector-based (ChAdOx1, Ad26.COV2.S) SARS-CoV-2 vaccines

Exclusion Criteria

Previous COVID-19-disease, use of antimetabolite drugs, such as Mycophenolate Mofetil, Azathioprine, Methotrexate two months prior to vaccination.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Humoral and cellular vaccination response in patients receiving Rituximab therapy, evaluated by quantification of SARS-CoV-2-IgG2 and IFN-g-release in patient blood, measured between one and 21 weeks after completed base immunisation.