COVID-19Phase 1BOOST_TX_SubANCT05338177
Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients
A Phase 1 study testing Immunosuppression reduction and No immunosuppression reduction in people with COVID-19, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Immunosuppression reduction and No immunosuppression reduction
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 15 Nov 2021to 14 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- Immunosuppression reduction, No immunosuppression reduction
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunosuppression reductionOther
participants stop mycophenolate or azathioprine one week before additional vaccine dose. Overall medication is stopped for two weeks.
No immunosuppression reductionOther
participants do not alter immunosuppresion
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppression reduction | Experimental | Participants stop mycophenolate or azathioprine for two weeks peri-vaccination. Treatment is stopped on week before vaccination and only restarted one week after vaccination Receives: Other: Immunosuppression reduction |
| No immunosuppression reduction | Active comparator | no alterations to immunosuppression Receives: Other: No immunosuppression reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion at 4 weeks
Number of patients developing SARS-CoV-2 antibodies at 4 weeks after vaccination
Measured: 4 weeks
Secondary outcomes (5)
Seroconversion at 7 days
Number of patients developing SARS-CoV-2 antibodies at 7 days after vaccination
Measured: 7 days
Antibody levels at 4 weeks
SARS-CoV-2 antibody levels at 4 weeks after vaccination
Measured: 4 weeks
Donor specific antibodies
Donor specific antibodies at 4 weeks after mycophenolate / azathioprine pausing
Measured: 4 weeks
Donor-derived cell free DNA
Donor-derived at 4 weeks after mycophenolate / azathioprine pausing
Measured: 4 weeks
Creatinine levels
Creatinine levels at 4 weeks after mycophenolate / azathioprine pausing
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start15 Nov 2021
- Primary completion15 Jan 2022
- Study completion14 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Reindl-Schwaighofe, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338177
- Sponsor's protocol ID
- BOOST_TX_SubA
- Acronym
- BOOST_TX_SubA
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial on Immunosuppression Modulation in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination
- ClinicalTrials.gov ID
- NCT05338177
- Acronym / sponsor ID
- BOOST_TX_SubA / BOOST_TX_SubA
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 14 Nov 2022 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunosuppression reduction | Experimental | Other: Immunosuppression reductionParticipants stop mycophenolate or azathioprine for two weeks peri-vaccination. Treatment is stopped on week before vaccination and only restarted one week after vaccination |
| No immunosuppression reduction | Active comparator | Other: No immunosuppression reductionno alterations to immunosuppression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunosuppression reductionparticipants stop mycophenolate or azathioprine one week before additional vaccine dose. Overall medication is stopped for two weeks. | Other | Immunosuppression reduction |
| No immunosuppression reductionparticipants do not alter immunosuppresion | Other | No immunosuppression reduction |
Primary outcome
Seroconversion at 4 weeks
Time frame: 4 weeks
Number of patients developing SARS-CoV-2 antibodies at 4 weeks after vaccination
5 secondary outcomes
Seroconversion at 7 days
Time frame: 7 days
Antibody levels at 4 weeks
Time frame: 4 weeks
Donor specific antibodies
Time frame: 4 weeks
Donor-derived cell free DNA
Time frame: 4 weeks
Creatinine levels
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Immunosuppression reduction and No immunosuppression reduction in people with COVID-19, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion at 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.