EUCTR2021-001040-10-AT
Active, not recruiting
Phase 1
Humoral and cellular immune response to COVID-19 vaccines in immunocompromised and healthy individuals – The CoVVac study - The CoVVac study
Medical University of Graz0 sites390 target enrollmentMarch 26, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Active immunisation to prevent COVID-19 in immunocompromised individuals.
- Sponsor
- Medical University of Graz
- Enrollment
- 390
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •2\.Patients with primary immunodeficiencies
- •3\.Patients with B\-cell depleting therapy due autoimmune disease
- •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.
- •5\.Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. CLL, MM) currently not receiving specific treatment.
- •6\.Patients \>3 months but \<12 months after autologous HSCT.
- •7\.Patients \>3 months but \<12 months after allogeneic HSCT.
- •8\.Recipients of HSCT \>12 months after allogeneic HSCT but under immunosuppressive therapy.
- •9\.Patients with chronic GvHD and persistent immunodeficiency.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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