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| Column | Value |
|---|---|
| Trial registration number | EUCTR2021-002348-57-AT |
|
Full text link
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002348-57/AT |
|
First author
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
|
|
Contact
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
selma.tobudic@meduniwien.ac.at |
|
Registration date
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
2021-05-10 |
|
Recruitment status
Last imported at : Nov. 4, 2022, noon Source : EU Clinical Trials Register |
Completed |
|
Study design
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
RCT |
|
Allocation
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Randomized |
|
Design
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Parallel |
|
Masking
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Blind label |
|
Center
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
single-center |
|
Study aim
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Prevention |
|
Inclusion criteria
Last imported at : Oct. 22, 2021, 8:30 a.m. Source : EU Clinical Trials Register |
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 |
|
Exclusion criteria
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
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 |
|
Number of arms
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
3 |
|
Funding
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Medical University of Vienna |
|
Inclusion age min
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
18 |
|
Inclusion age max
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
100 |
|
Countries
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Austria |
|
Type of patients
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Healthy volunteers |
|
Severity scale
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
N/A |
|
Total sample size
Last imported at : Sept. 18, 2023, 2:45 p.m. Source : EU Clinical Trials Register |
68 |
|
primary outcome
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Primary study endpoint Difference in SARS-CoV-2 antibody seroconversion rate by week 4 after vaccination boost at baseline between 3rd mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) and vector SARS-CoV-2 vaccine (AstraZeneca). |
|
Notes
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
nan |
|
Phase
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Phase 2 |
|
Arms
Last imported at : June 11, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
[{"arm_notes": "30\u00b5g second boost;no humoral response after standard mRNA vaccination", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100\u00b5g second boost;no humoral response after standard mRNA vaccination", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "250000000 U unit(s) second boost;no humoral response after standard mRNA vaccination", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |