Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Immunological safety - anti-HLA antibodies
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Immunological safety - anti-HLA antibodies
Time Frame: Comparison of anti-HLA single antigen bead assays at booster dose and three months later.
Emergence of de novo anti-HLA/donor specific antibodies, increase of preformed anti-HLA/donor specific antibodies above 50% of pre-booster level.
Immunological safety - donor-derived cell-free DNA
Time Frame: Comparison of dd-cfDNA assays at booster dose and three months later.
Elevation of dd-cfDNA above 1% threshold
Secondary Outcomes
- Immunological effectiveness - anti-SARS-CoV-2 antibodies(Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.)
Investigators
Prof. Ondřej Viklický, M.D., Ph.D.
Head of the Transplant Center, Head of the Department of Nephrology, Principle Investigator, Clinical Professor
Institute for Clinical and Experimental Medicine