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NCT05483725 Clinical Trial

Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05483725
Other study ID # G-21-71
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 4, 2021
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Institute for Clinical and Experimental Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Booster dose of mRNA vaccine
Administration of SARS-CoV-2 mRNA vaccine.

Locations
Country Name City State
Czechia Institute for Clinical and Experimental Medicine Praha

Sponsors (1)
Lead Sponsor Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome
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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