Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients (BOOST_TX_SubA)

Pilot Trial on Immunosuppression Modulation in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination

Mycophenolate has been identified as risk factor for non-response to SARS-CoV-2 vaccination in kidney transplant recipients. Safety and efficacy of temporarily stopping of mycophenolate (or azathioprine) to increase vaccine response has not been established.

This is a non-randomized, controlled pilot study including up to 40 kidney transplant recipients not responding to at least three previous SARS-CoV-2 vaccine doses. Mycophenolate or azathioprine will be stopped for two weeks peri-vaccination starting one week before vaccination until one week after vaccination. Allocation to mycophenoalte or azathioprine discontinuation arm will be based on an overall risk assessment by the transplant physician and patient preference. Patients not stopping mycophenolate or azathioprine will serve as control group.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Immunosuppression reduction; Other: No immunosuppression reduction

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical 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
• > 18 years of age
• No SARS-CoV-2 spike protein antibodies four weeks after at least three previous vaccine doses
• Maintenance immunosuppression with mycophenolate or azathioprine

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
• SARS-CoV-2 spike protein antibodies four weeks after the 3rd last vaccination > 0.8 BAU/mL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunosuppression reduction; Participants stop mycophenolate or azathioprine for two weeks peri-vaccination. Treatment is stopped on week before vaccination and only restarted one week after vaccination	Other: Immunosuppression reduction; participants stop mycophenolate or azathioprine one week before additional vaccine dose. Overall medication is stopped for two weeks.
Active Comparator: No immunosuppression reduction; no alterations to immunosuppression	Other: No immunosuppression reduction; participants do not alter immunosuppresion

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 vaccination	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion at 7 days	Number of patients developing SARS-CoV-2 antibodies at 7 days after vaccination	7 days
Antibody levels at 4 weeks	SARS-CoV-2 antibody levels at 4 weeks after vaccination	4 weeks
Donor specific antibodies	Donor specific antibodies at 4 weeks after mycophenolate / azathioprine pausing	4 weeks
Donor-derived cell free DNA	Donor-derived at 4 weeks after mycophenolate / azathioprine pausing	4 weeks
Creatinine levels	Creatinine levels at 4 weeks after mycophenolate / azathioprine pausing	4 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): January 15, 2022
• Study Completion (Anticipated): November 14, 2022

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 16, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BOOST_TX_SubA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No