Trials / Unknown
UnknownNCT05483725
Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.
Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 108 (actual)
- Sponsor
- Institute for Clinical and Experimental Medicine · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
- Kidney Diseases
- Kidney Transplant; Complications
- COVID-19
- Vaccine Adverse Reaction
- Rejection Acute Renal
- Rejection Chronic Renal
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Booster dose of mRNA vaccine | Administration of SARS-CoV-2 mRNA vaccine. |
Timeline
- Start date
- 2021-10-04
- Primary completion
- 2024-12-04
- Completion
- 2024-12-31
- First posted
- 2022-08-02
- Last updated
- 2024-03-06
Locations
1 site across 1 country: Czechia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05483725. Inclusion in this directory is not an endorsement.