Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients (BOOST_TX)

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Medical University of Vienna

Status and phase

Active, not recruiting
Phase 2

Conditions

COVID-19

Treatments

Drug: mRNA-1273
Drug: Ad26COVS1
Drug: BNT162B2
Drug: ChAdOx1 SARS2 Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT05324319
BOOST_TX

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups

homologous 3rd vaccination (mRNA vaccine)
Active Comparator group
Description:
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 )
Treatment:
Drug: BNT162B2
Drug: mRNA-1273
heterologous 3rd vaccination (vector vaccine)
Experimental group
Description:
participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)
Treatment:
Drug: ChAdOx1 SARS2 Vaccine
Drug: Ad26COVS1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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