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

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

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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