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Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients

Single Blinded Randomized Controlled Trial on BNT162b2 or mRNA-1273 (mRNA) vs Ad26COVS1 or ChAdOx1-S (Viral Vector) for Third Vaccination in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination

NCT05324319•Medical University of Vienna

View on ClinicalTrials.gov

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-boost vaccination with an mRNA vaccine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (1)

Medicial University of Vienna

Vienna, Austria

Key Dates

Start Date

June 15, 2021

Primary Completion Date

July 31, 2022

Completion Date

December 31, 2022

Last Updated

April 20, 2022

Enrollment

200

ACTUAL participants

Conditions

COVID-19

Interventions

Ad26COVS1

DRUG

ChAdOx1 SARS2 Vaccine

DRUG

BNT162B2

DRUG

mRNA-1273

DRUG

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

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COVID-19

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RECRUITINGNA

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Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients

Inclusion Criteria

Exclusion Criteria

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