Status:
COMPLETED
Humoral and Cellular Immune Response to COVID-19 Vaccines in Immunocompromised and Healthy Individuals
Lead Sponsor:
Medical University of Graz
Conditions:
Covid19
Immunosuppression
Eligibility:
All Genders
16+ years
Brief Summary
Currently, the efficacy of COVID-19 vaccination in immunodeficient patients is unknown. Here the investigators aim to evaluate the efficacy of COVID-19 vaccines in immunodeficient patients compared to...
Detailed Description
The total duration of the study is 38 months, starting in March 2021 with a recruiting period until 31. December 2021 and termination of all scheduled visits until 31 May 2024. Individuals having cons...
Eligibility Criteria
Inclusion
- Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement.
- or
- Patients with primary immunodeficiencies or
- Patients with B-cell depleting therapy due to autoimmune disease or
- 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
- Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. chronic lymphatic leukemia, MM) currently not receiving specific treatment.
- or
- Patients \>3 months but \<12 months after autologous HSCT (hematopoietic stem cell transplantation).
- or
- Patients \>3 months but \<12 months after allogeneic HSCT. or
- Recipients of HSCT \>12 months after allogeneic HSCT but under immunosuppressive therapy.
- or
- Patients with chronic GvHD (graft-versus-host disease) and persistent immunodeficiency.
Exclusion
- Healthy participants
- Presence of diseases or therapies that are likely to interfere with the immune response to vaccination.
- Presence of a disease requiring change in therapy during 4 weeks before enrollment.
- Any contraindications to the vaccine planned to receive as listed in the product characteristics.
- Lack of willingness to undergo serial blood draws and attend follow-up appointments.
- Women who are pregnant or breastfeeding.
- Previous vaccination with any coronavirus vaccine.
- Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).
- Immunodeficient participants
- Patients with hematological diseases within three months from B-cell-depleting immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells (Chimeric Antigen Receptor).
- Patients with hematological malignancies in remission and \>12 months after end of specific therapy.
- Patients within three months from HSCT.
- Any contraindications to the vaccine planned to receive as listed in the product characteristics.
- Lack of willingness to undergo serial blood draws and attend follow-up appointments.
- Women who are pregnant or breastfeeding.
- Previous vaccination with any coronavirus vaccine (exception: if serum prior to vaccination is available from the biobank).
- Patients who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).
Key Trial Info
Start Date :
April 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 20 2023
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT04858607
Start Date
April 19 2021
End Date
January 20 2023
Last Update
February 9 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Graz
Graz, Austria