Assessment of effectiveness and safety of a 3rd dose of mRNA vaccine 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

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000319-30-CZ

Enrollment

180

Registered

2022-01-24

Start date

2022-03-09

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 infection in kidney transplant recipients

Interventions

Trade Name: N/A Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM) - vaccinated with 2 doses of BNT162b2 - immunosuppressive regimen includes mycophenolic acid or mycophenolate mofetil - COVID naive and/or COVID survivors 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 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: - age < 18 years - pregnant women, breastfeeding women - unable/unwilling to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate safety, immunogenicity and effectiveness of booster dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients;Secondary Objective: Not applicable;Primary end point(s): - SARS-CoV-2 PCR positivity after 3rd dose of SARS-CoV-2 mRNA vaccine - adverse events after 3rd dose of SARS-CoV-2 mRNA vaccine;Timepoint(s) of evaluation of this end point: SARS-CoV-2 PCR test positivity is being mandatorily reported to government run registry (ISIN), hence the timepoint of evaluation is every day from D0 to M12. Adverse events are assessed by phone or e-mail during 2-4 weeks after administration of the third dose.	—

Measure

Time frame

Main Objective: Evaluate safety, immunogenicity and effectiveness of booster dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients;Secondary Objective: Not applicable;Primary end point(s): - SARS-CoV-2 PCR positivity after 3rd dose of SARS-CoV-2 mRNA vaccine - adverse events after 3rd dose of SARS-CoV-2 mRNA vaccine;Timepoint(s) of evaluation of this end point: SARS-CoV-2 PCR test positivity is being mandatorily reported to government run registry (ISIN), hence the timepoint of evaluation is every day from D0 to M12. Adverse events are assessed by phone or e-mail during 2-4 weeks after administration of the third dose.

—

Secondary

Measure	Time frame
Secondary end point(s): - development and/or change of antiHLA antibodies - development and/or change of anti-SARS-CoV-2 antibodies - development and/or change of cellular anti-SARS-CoV-2 immune response;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months after 3rd dose of SARS-CoV-2 mRNA vaccine	—

Countries

Czech Republic

Contacts

Public ContactAZV CR

Agentura pro Zdravotnický Výzkum Ceské Republiky

info@azvcr.cz00420271 019257

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 7, 2026