Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients
NCT ID: NCT05338177
Last Updated: 2022-04-21
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
PHASE1
40 participants
INTERVENTIONAL
2021-11-15
2022-11-14
Brief Summary
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This is a non-randomized, controlled pilot study including up to 40 kidney transplant recipients not responding to at least three previous SARS-CoV-2 vaccine doses. Mycophenolate or azathioprine will be stopped for two weeks peri-vaccination starting one week before vaccination until one week after vaccination. Allocation to mycophenoalte or azathioprine discontinuation arm will be based on an overall risk assessment by the transplant physician and patient preference. Patients not stopping mycophenolate or azathioprine will serve as control group.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Immunosuppression reduction
Participants stop mycophenolate or azathioprine for two weeks peri-vaccination. Treatment is stopped on week before vaccination and only restarted one week after vaccination
Immunosuppression reduction
participants stop mycophenolate or azathioprine one week before additional vaccine dose. Overall medication is stopped for two weeks.
No immunosuppression reduction
no alterations to immunosuppression
No immunosuppression reduction
participants do not alter immunosuppresion
Interventions
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Immunosuppression reduction
participants stop mycophenolate or azathioprine one week before additional vaccine dose. Overall medication is stopped for two weeks.
No immunosuppression reduction
participants do not alter immunosuppresion
Eligibility Criteria
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Inclusion Criteria
* \> 18 years of age
* No SARS-CoV-2 spike protein antibodies four weeks after at least three previous vaccine doses
* Maintenance immunosuppression with mycophenolate or azathioprine
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
* SARS-CoV-2 spike protein antibodies four weeks after the 3rd last vaccination \> 0.8 BAU/mL
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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Medical University of Vienna
Vienna, , Austria
Countries
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Other Identifiers
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BOOST_TX_SubA
Identifier Type: -
Identifier Source: org_study_id
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