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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: BNT162B2; Drug: mRNA-1273; Drug: Ad26COVS1; Drug: ChAdOx1 SARS2 Vaccine

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medicial University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 )	Drug: BNT162B2; Homologous vaccination; Drug: mRNA-1273; Homologous vaccination
Experimental: heterologous 3rd vaccination (vector vaccine); participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)	Drug: Ad26COVS1; Heterologous vaccination; Drug: ChAdOx1 SARS2 Vaccine; Heterologous vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion at 4 weeks	number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion at 12 weeks	number of patients developing SARS-CoV-2 antibodies at 12 weeks after 3rd vaccination (> 0.8 BAU/mL)	3 months
SARS-CoV-2 antibody levels at 4 weeks	SARS-CoV-2 antibody levels at 4 weeks after the third vaccination	4 weeks
SARS-CoV-2 antibody levels at 12 weeks	SARS-CoV-2 antibody levels at 12 weeks after the third vaccination	3 months
Seroconversion at 36 weeks	number of patients developing SARS-CoV-2 antibodies at 36 weeks after 3rd vaccination (> 0.8 BAU/mL)	6 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BOOST_TX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No