An observational study to investigate the effectiveness and safety of Corona vaccines in patients with rheumatologic diseases.

A low-interventional study to investigate the efficacy and safety of SARS-CoV-2 vaccines in patients with rheumatic diseases. - VACCIMMUN

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002245-15-DE

Enrollment

250

Registered

2021-04-30

Start date

2021-05-25

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auto Immune Rheumatic Diseases (AIRD) and patients without rheumatic autoimmune diseases (control group). MedDRA version: 20.0 Level: PT Classification code 10072736 Term: Rheumatic disorder System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Comirnaty Pharmaceutical Form: Solution for injection Trade Name: Vaxzevria Pharmaceutical Form: Solution for injection Trade Name: COVID-19 Vaccine Janssen Pharmaceutical Form: Solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. written consent for study participation. 2. if study entry after first vaccination: written informed consent for analysis of any archived blood samples. 3. males and females = 18 years of age. 4. either arm 1 (AIRD patients): diagnosis of rheumatic autoimmune disease or arm 2 (control group): no diagnosis of rheumatic autoimmune disease. 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 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 450

Exclusion criteria

Exclusion criteria: 1. persons not capable of giving consent 2. serious illnesses which, in the opinion of the investigator, preclude inclusion or continued observation (for example, tumor diseases requiring intensive chemotherapy). 3. individuals who are unable or unwilling to undergo multiple venipunctures because he/she is intolerant or has poor venous conditions. 4. persons who are admitted to an institution by court order or by order of the authorities.

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify AIRD-specific variables that influence the expression and duration of vaccine protection following SARS-CoV-2 vaccination.;Secondary Objective: - investigation of the influence of the rheumatic disease and other relevant medical data, such as disease activity and drug therapy or B-Cell status, on the vaccination success. - evaluation of the side effect profile of the vaccines, also with regard to the disease activity of the rheumatic disease and with regard to a possible induction of autoantibodies, e.g. ANA, RF, ACPA, anti-phospholipid-Ak. - Determination of the extent and duration of vaccine protection after SARS-CoV-2 vaccination based on the occurrence of symptomatic or asymptomatic, laboratory detectable disease of COVID-19 of the SARS-CoV-2 virus.;Primary end point(s): Evaluation of humoral and/or cellular vaccination response after SARS-Cov-2 vaccination. ;Timepoint(s) of evaluation of this end point: 3, 6, 12 and 24 months after initial vaccination as part of regular routine visits plus optional 14 days after each vaccination. If patients have received a third vaccination or even further vaccinations, the following dates are planned, in each case starting from the last vaccination carried out and up to the planned end of the study on 31-DEC-2023: Approximately 1/3/5/12/24 months after last vaccination.	—

Measure

Time frame

Main Objective: To identify AIRD-specific variables that influence the expression and duration of vaccine protection following SARS-CoV-2 vaccination.;Secondary Objective: - investigation of the influence of the rheumatic disease and other relevant medical data, such as disease activity and drug therapy or B-Cell status, on the vaccination success. - evaluation of the side effect profile of the vaccines, also with regard to the disease activity of the rheumatic disease and with regard to a possible induction of autoantibodies, e.g. ANA, RF, ACPA, anti-phospholipid-Ak. - Determination of the extent and duration of vaccine protection after SARS-CoV-2 vaccination based on the occurrence of symptomatic or asymptomatic, laboratory detectable disease of COVID-19 of the SARS-CoV-2 virus.;Primary end point(s): Evaluation of humoral and/or cellular vaccination response after SARS-Cov-2 vaccination. ;Timepoint(s) of evaluation of this end point: 3, 6, 12 and 24 months after initial vaccination as part of regular routine visits plus optional 14 days after each vaccination. If patients have received a third vaccination or even further vaccinations, the following dates are planned, in each case starting from the last vaccination carried out and up to the planned end of the study on 31-DEC-2023: Approximately 1/3/5/12/24 months after last vaccination.

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Secondary

Measure	Time frame
Secondary end point(s): - Recording of rheumatic diagnosis, immunosuppressive therapies, disease activity and possible relapses of the underlying rheumatologic disease after SARS-CoV-2 vaccination or B-cell status. - Recording of the side effect profile after SARS-CoV-2 vaccination - Determination of autoantibodies (e.g. ANA, RF, ACPA, anti-phospholipid-Ak) after SARS-CoV-2 vaccination - Determination of the frequency of SARS-CoV-2 infections despite vaccination;Timepoint(s) of evaluation of this end point: 3, 6, 12 and 24 months after initial vaccination as part of regular routine visits plus optional 14 days after each vaccination. If patients have received a third vaccination or even further vaccinations, the following dates are planned, in each case starting from the last vaccination carried out and up to the planned end of the study on 31-DEC-2023: Approximately 1/3/5/12/24 months after last vaccination.	—

Measure

Time frame

Secondary end point(s): - Recording of rheumatic diagnosis, immunosuppressive therapies, disease activity and possible relapses of the underlying rheumatologic disease after SARS-CoV-2 vaccination or B-cell status. - Recording of the side effect profile after SARS-CoV-2 vaccination - Determination of autoantibodies (e.g. ANA, RF, ACPA, anti-phospholipid-Ak) after SARS-CoV-2 vaccination - Determination of the frequency of SARS-CoV-2 infections despite vaccination;Timepoint(s) of evaluation of this end point: 3, 6, 12 and 24 months after initial vaccination as part of regular routine visits plus optional 14 days after each vaccination. If patients have received a third vaccination or even further vaccinations, the following dates are planned, in each case starting from the last vaccination carried out and up to the planned end of the study on 31-DEC-2023: Approximately 1/3/5/12/24 months after last vaccination.

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Countries

Germany

Contacts

Public ContactRheumatologie Studienabteilung

Charité - Universitätsmedizin Berlin

rheumastudien@charite.de004930450513025

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026