Status:
UNKNOWN
Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients
Lead Sponsor:
Medical University of Vienna
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomized-controlled trial comparing homologous (mRNA vaccine) vs. heterologous (vector vaccine) for third SARS-CoV-2 vaccine dose in kidney transplant recipients not responding to initial prime-boos...
Eligibility Criteria
Inclusion
- patient has received a kidney transplantation
- full SARS-CoV-2 vaccination with mRNA vaccine (two doses) at least 4 weeks before screening
- \> 18 years of age
- no SARS-CoV-2 spike protein antibodies at least 4 weeks after the second dose of an mRNA vaccine
Exclusion
- acute illness with fever
- Prior documented infection with SARS-CoV-2
- triple anticoagulation therapy
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
- Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
- Subject is pregnant or breast feeding
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05324319
Start Date
June 15 2021
End Date
December 31 2022
Last Update
April 20 2022
Active Locations (1)
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1
Medicial University of Vienna
Vienna, Austria, 1090