Antibody and cellular response 28 days after the first dose of COVID-19 vaccine (Moderna) and then 33 weeks after the second dose and 8-12 weeks after the third dose in clinically stable patients with functional kidney transplantation.
Conditions
Interventions
Sponsors
Fakultní nemocnice Hradec Králové
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age 20 = 75 years 2. the ability to understand the nature and course of the study and to agree in writing to the study by signing Informed Consent 3. Day 28 after dosing Moderna 4. with a functional kidney transplant 5. with stable function of the transplanted kidney (graft) 6. more than 3 months after kidney transplantation 7. no change in immunosuppressive therapy and / or no infection since the Moderna dose was given Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. insufficient venous system in the upper limbs with the risk of having repeated intravenous injections to obtain a blood sample 2. past COVID-19 disease 3. concurrent participation in another clinical trial 4. pregnancy, breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To describe the antibody and cellular response in clinically stable patients after successful kidney transplantation 33 weeks after the second dose of the registered mRNA-vaccine against COVID-19 disease (Spikevax vaccine, Moderna), ie on the day of the third dose of vaccine. 2. To describe the antibody and cellular response in the same group of clinically stable patients after successful kidney transplantation 8-12 weeks after this third vaccination dose. ;Secondary Objective: 1. To evaluate the clinical course in the interval between the 2nd and 3rd dose of the Moderna vaccine in terms of the incidence of de-novo disease COVID-19, to use the given IgG antibodies for evaluation. 2. Evaluate the clinical course in the interval between the 3rd dose and control collection in the range of 8-12 weeks after its administration, verify the tolerance of the vaccine and analyze other routinely monitored clinical and laboratory parameters, including pharmacotherapy, for antibody and cellular response to the vaccine. 3. Distinguish the antibody response elicited by a possible asymptomatic SARS-Cov-2 infection from the vaccine-induced antibody response (simultaneous examination of two different IgG proteins, detection of antibodies against spike protein after vaccination vs detection of NP-protein after disease).;Primary end point(s): To describe the antibody and cellular response in clinically stable patients after successful kidney transplantation 33 weeks after the second dose of the registered mRNA-vaccine against COVID-19 disease (Spikevax vaccine, Moderna), ie on the day of the third dose of vaccine.;Timepoint(s) of evaluation of this end point: After all blood samples collections. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To describe the antibody and cellular response in the same group of clinically stable patients after successful kidney transplantation 8-12 weeks after this third vaccination dose.;Timepoint(s) of evaluation of this end point: 28 days after the first dose of COVID-19 vaccine (Moderna) and 33 weeks after the second dose and 8-12 weeks after the third dose in clinically stable patients with functional kidney transplantation. | — |
Countries
Czech Republic
Contacts
Public ContactOddelení klinických hodnocení
Fakultní nemocnice Hradec Králové
Outcome results
None listed