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
- 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.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-002014-14-CZ
- Lead Sponsor
- Fakultní nemocnice Hradec Králové
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method