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

Sponsor

Medical University of Vienna (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05338177

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Other: Immunosuppression reduction Other: No immunosuppression reduction	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 15, 2021

Actual Primary Completion Date :

Jan 15, 2022

Anticipated Study Completion Date :

Nov 14, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Seroconversion at 4 weeks [4 weeks]
Number of patients developing SARS-CoV-2 antibodies at 4 weeks after vaccination

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical 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:

NCT05338177

Other Study ID Numbers:

BOOST_TX_SubA

First Posted:

Apr 21, 2022

Last Update Posted:

Apr 21, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 21, 2022