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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05324319
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.5
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Ad26COVS1; Drug: ChAdOx1 SARS2 Vaccine; Drug: BNT162B2; Drug: mRNA-1273	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: Jun 15, 2021
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Seroconversion at 4 weeks [4 weeks]

   number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination

Secondary Outcome Measures

1. Seroconversion at 12 weeks [3 months]

   number of patients developing SARS-CoV-2 antibodies at 12 weeks after 3rd vaccination (> 0.8 BAU/mL)

2. SARS-CoV-2 antibody levels at 4 weeks [4 weeks]

   SARS-CoV-2 antibody levels at 4 weeks after the third vaccination

3. SARS-CoV-2 antibody levels at 12 weeks [3 months]

   SARS-CoV-2 antibody levels at 12 weeks after the third vaccination

4. Seroconversion at 36 weeks [6 months]

   number of patients developing SARS-CoV-2 antibodies at 36 weeks after 3rd vaccination (> 0.8 BAU/mL)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medicial University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roman Reindl-Schwaighofe, Principal Investigator, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05324319
• Other Study ID Numbers: BOOST_TX
• First Posted: Apr 12, 2022
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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

Study Results

No Results Posted as of Apr 20, 2022