Covid19 Clinical Trial
Official title:
Evaluation of Post-SARS-CoV-2 Vaccinal Response in Immunocompromised Patients
NCT number | NCT05672654 |
Other study ID # | VACCIM |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 10, 2021 |
Est. completion date | September 1, 2023 |
Verified date | September 2023 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to identify both the humoral immunological response through the detection of induced antibodies and the cellular immunological response through the detection of interferon gamma production by functional CD4+ and CD8+ cells in different groups of immunocompromised patients. For antibody detection, LIAISON® SARS-CoV-2 TrimericS assay (DiaSorin) will be used and for the evaluation of cellular immunity - QuantiFERON SARS-CoV-2 assay (QIAGEN).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 100 Years |
Eligibility | Inclusion Criteria: Following patient groups receiving the Pfizer vaccine - HIV-positive patients with CD4 < 350 cellen/mm3 - Common variable immunodeficiency disorders en primary immunodeficiency disorders - Immune-compromised patients hospitalized at rheumatology/neurology/nephrology Exclusion Criteria: - patients receiving a different of vaccine |
Country | Name | City | State |
---|---|---|---|
Belgium | UH Ghent | Ghent | East Flanders |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Humoral immune response | Detection of Antibodies | prior or at the time of first dose of vaccine until 12 months after second dose of vaccine | |
Primary | Cellular immune response | DetectionINF-gamma by functional CD4+ and CD8+ cells | prior or at the time of first dose of vaccine until 12 months after second dose of vaccine |
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