EUCTR2021-002348-57-AT
Active, not recruiting
Phase 1
A Randomized, Parallel Group, Single-Blind, Phase 2 Study to Evaluate the immune response of two classes of SARS-Cov-2 Vaccines employed as Third Vaccination in Patients under current Rituximab Therapy and no humoral response after standard mRNA vaccination - Immune response after three dosis of SARS-CoV-2 (COVID-19) vaccination
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medical University of Vienna
- Enrollment
- 68
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subjects will be eligible for participation in this study if they:
- •1\.Are \=18 years on the day of screening
- •2\.Have a chronic condition and have been treated with a B\-cell depleting therapy (rituximab) within the last 12 months
- •3\.Received mRNA SARS\-CoV\-2 (Biontech/Pfizer or Moderna) vaccine
- •4\.Did not develop humoral immunity 4 weeks after second mRNA vaccination to SARS\-CoV\-2 (analyzed during the study Characterization of immune responsiveness after mRNA SARS\-CoV\-2 Vaccination in patients with immunodeficiency or immunosuppressive therapy”, EK\-Nr. 1073/2021, EudraCT Nr. 2021\-000291\-11\)
- •5\.A maximum of 6 months after second vaccination
- •6\.Have an understanding of the study, agree to its provisions, and give written informed consent before study entry
- •7\.If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Subjects will be excluded from participation in this study if they:
- •1\.Have shown humoral response to the SARS\-CoV\-2 vaccination
- •2\.Had grade 3 adverse effects from the mRNA vaccination reported
- •3\.Pregnancy and breast feeding
- •4\.Signs of SARS\-CoV\-2 infection (including previous positive PCR testing)
- •5\.Any other contraindication to any of the study compounds
- •6\.Urgent need for next rituximab application
Outcomes
Primary Outcomes
Not specified
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