COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002693-10/AT

Medical University of Vienna - Clinical Trials Office

daniela.sieghart@meduniwien.ac.at

2021-05-19

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

a) Male and female patients will be eligible for participation in this study if they: 1. Are ≥18 years on the day of screening 2. Being immunocompromised (either primary or secondary immunodeficiency or been treated with immunosuppressive therapy within the last 12 months Immunosuppressive therapies include glucocorticoids, cytostatics, antibodies, drugs acting on immunophilins and other treatments like interferons and TNF binding proteins and exclude patients under B cell depleting therapy (like Rituximab, Ocrelicumab, Ofatumumab, Epratuzumab or Obinutuzumab) 3. Received two doses of SARS-CoV-2 (Biontech/Pfizer, Moderna) vaccine according to recommendations in the label and/or national guidelines. 4. Did develop < 1500 U/ml of SARS-CoV-2 antibodies 4 weeks after second mRNA vaccination (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, or external routine evaluation of humoral response) 5. A maximum of 12 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 b) Male and female healthy controls will be eligible for participation in this study if they: 1. Are ≥18 years on the day of screening 2. Received two doses of SARS-CoV-2 (Biontech/Pfizer, Moderna) vaccine according to recommendations in the label and/or national guidelines. 3. Did develop < 1500 U/ml of SARS-CoV-2 antibodies 4 weeks after second mRNA vaccination 4. A maximum of 12 months after second vaccination 5. Have an understanding of the study, agree to its provisions, and give written informed consent before study entry 6. 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

Subjects will be excluded from participation in this study if they: 1. Have shown humoral response (> 1500 U/ml) 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 vaccine compounds 6. For healthy controls: diagnosis of chronic inflammatory condition including primary or secondary immunodeficiency or ever receiving immunosuppressing therapy as stated above

3

Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology

18

100

Austria

High risk patients

N/A

300

A) 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). B) The efficacy of a 3rd mRNA boost vaccination in immunocompromised patients with inadequate humoral response (antibody titre <1500U/ml) to standard SARS-CoV-2 vaccination will be compared to low titre heathy controls by assessing the difference in antibody titre change before and after a second boost between the two groups.

nan

Phase 2

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