Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients
NCT ID: NCT05324319
Last Updated: 2022-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2021-06-15
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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homologous 3rd vaccination (mRNA vaccine)
Participants will receive a third SARS-CoV-2 vaccination with the same mRNA vaccine they received for the initial prime-boost vaccination (BNT162b2 or mRNA-1273 )
BNT162B2
Homologous vaccination
mRNA-1273
Homologous vaccination
heterologous 3rd vaccination (vector vaccine)
participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)
Ad26COVS1
Heterologous vaccination
ChAdOx1 SARS2 Vaccine
Heterologous vaccination
Interventions
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Ad26COVS1
Heterologous vaccination
ChAdOx1 SARS2 Vaccine
Heterologous vaccination
BNT162B2
Homologous vaccination
mRNA-1273
Homologous vaccination
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Roman Reindl-Schwaighofe
Principal Investigator
Locations
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Medicial University of Vienna
Vienna, , Austria
Countries
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Other Identifiers
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BOOST_TX
Identifier Type: -
Identifier Source: org_study_id
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