COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001040-10/AT

Medical University of Graz - Clinical Trials Information

martin.stradner@medunigraz.at

2021-03-26

Completed

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet one of the following inclusion criteria: 1. Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement. or 2. Patients with primary immunodeficiencies or 3. Patients with B-cell depleting therapy due autoimmune disease or 4. Patients with benign and malignant hematological diseases receiving specific treatments with known immunosuppressive effects including cytotoxic agents, systemic corticosteroids, monoclonal antibodies and targeted therapies. or 5. Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. CLL, MM) currently not receiving specific treatment. or 6. Patients >3 months but <12 months after autologous HSCT. or 7. Patients >3 months but <12 months after allogeneic HSCT. or 8. Recipients of HSCT >12 months after allogeneic HSCT but under immunosuppressive therapy. or 9. Patients with chronic GvHD and persistent immunodeficiency.

Subjects meeting any of the following criteria cannot be enrolled into the trial: Healthy participants 1. Presence of diseases or therapies that are likely to interfere with the immune response to vaccination. 2. Presence of a disease requiring change in therapy during 4 weeks before enrollment. 3. Any contraindications to the vaccine planned to receive as listed in the product characteristics. 4. Lack of willingness to undergo serial blood draws and attend follow-up appointments. 5. Women who are pregnant or breastfeeding. 6. Previous vaccination with any coronavirus vaccine. 7. Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent). Immunodeficient participants 1. Patients with hematological diseases within three months from B-cell-depleting immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells). 2. Patients with hematological malignancies in remission and >12 months after end of specific therapy. 3. Patients within three months from HSCT. 4. Any contraindications to the vaccine planned to receive as listed in the product characteristics. 5. Lack of willingness to undergo serial blood draws and attend follow-up appointments. 6. Women who are pregnant or breastfeeding. 7. Previous vaccination with any coronavirus vaccine (exception: if serum prior to vaccination is available from the biobank). 8. Patients who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).

3

Medical University of Graz

18

100

Austria

Healthy volunteers

N/A

390

The seroconversion leading to anti-SARS-CoV-2 spike protein humoral immune response at day 21-28 after the second vaccination measured by SARS-CoV-2 antigen-binding Ig assay, comparing immunocompromised patients to healthy controls.

nan

Phase 4

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