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

NCT ID: NCT05324319

Last Updated: 2022-04-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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 )

Group Type ACTIVE_COMPARATOR

BNT162B2

Intervention Type DRUG

Homologous vaccination

mRNA-1273

Intervention Type DRUG

Homologous vaccination

heterologous 3rd vaccination (vector vaccine)

participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)

Group Type EXPERIMENTAL

Ad26COVS1

Intervention Type DRUG

Heterologous vaccination

ChAdOx1 SARS2 Vaccine

Intervention Type DRUG

Heterologous vaccination

Interventions

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Ad26COVS1

Heterologous vaccination

Intervention Type DRUG

ChAdOx1 SARS2 Vaccine

Heterologous vaccination

Intervention Type DRUG

BNT162B2

Homologous vaccination

Intervention Type DRUG

mRNA-1273

Homologous vaccination

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Roman Reindl-Schwaighofe

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medicial University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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BOOST_TX

Identifier Type: -

Identifier Source: org_study_id

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