COVID-19 Clinical Trial
Official title:
Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.
Verified date | March 2024 |
Source | Institute for Clinical and Experimental Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation.
Status | Active, not recruiting |
Enrollment | 108 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 4, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM) - vaccinated with 2 doses of mRNA vaccine (BNT-162b2 or mRNA-1273) - immunosuppressive regimen includes or does not include mycophenolic acid or mycophenolate mofetil - COVID naive Exclusion Criteria: - age < 18 years - pregnant women, breastfeeding women - unable/unwilling to give informed consent |
Country | Name | City | State |
---|---|---|---|
Czechia | Institute for Clinical and Experimental Medicine | Praha |
Lead Sponsor | Collaborator |
---|---|
Institute for Clinical and Experimental Medicine |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunological safety - anti-HLA antibodies | Emergence of de novo anti-HLA/donor specific antibodies, increase of preformed anti-HLA/donor specific antibodies above 50% of pre-booster level. | Comparison of anti-HLA single antigen bead assays at booster dose and three months later. | |
Primary | Immunological safety - donor-derived cell-free DNA | Elevation of dd-cfDNA above 1% threshold | Comparison of dd-cfDNA assays at booster dose and three months later. | |
Secondary | Immunological effectiveness - anti-SARS-CoV-2 antibodies | Emergence or increase of anti-SARS-CoV-2 IgG. | Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later. |
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