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PREPARE-iVAC
EU CTIS ID: 2023-503894-39-00
What this study is testing
To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titers
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- ≥6 months after kidney transplantation
- Eligible for the vaccinations as described by the instructions of the manufacturers of the vaccines (e.g. received 3 previous COVID-19 vaccinations as part of the primary COVID-19 immunisation)
- Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- Willing to adhere to the protocol and be available during the study period
- Maintenance immunosuppressive therapy consisting of either triple or dual therapy including MMF/MPA with a minimum daily dose of 1000 mg (MMF) or 720 mg (MPA) and a CNI
You likely can't join if
- Multi-organ transplant recipient
- Simultaneous participation in another interventional study that will likely influence the study outcomes
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s)
- Active COVID-19 disease
- Additional for part 2: Active varicella or herpes zoster disease
- Active malignancy, except non-melanoma skin cancer
See the full eligibility criteria
- Age ≥ 18 years
- ≥6 months after kidney transplantation
- Eligible for the vaccinations as described by the instructions of the manufacturers of the vaccines (e.g. received 3 previous COVID-19 vaccinations as part of the primary COVID-19 immunisation)
- Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- Willing to adhere to the protocol and be available during the study period
- Maintenance immunosuppressive therapy consisting of either triple or dual therapy including MMF/MPA with a minimum daily dose of 1000 mg (MMF) or 720 mg (MPA) and a CNI
- Multi-organ transplant recipient
- Simultaneous participation in another interventional study that will likely influence the study outcomes
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s)
- Active COVID-19 disease
- Additional for part 2: Active varicella or herpes zoster disease
- Active malignancy, except non-melanoma skin cancer
- Inherited immune deficiency
- Infection with Human Immunodeficiency Virus (HIV)
- Administration of T-cell, B-cell, or plasma cell depleting antibodies during the last 6 months
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
- Previous CNI trough levels not sufficient according to the discretion of the treating physician
- Subjects with severe systemic infections, current or within the two weeks prior to randomisation
- More than two previous kidney transplantations
- Calculated level of panel reactive antibodies prior to last transplantation above 85%
- Evidence of DSAs
- Signs of acute rejection during the preceding year
- Subjects with severe restrictive or obstructive pulmonary disorders
- Subjects with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled
- Subjects with white blood cell (WBC) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 at last outpatient clinic visit
- Proteinuria > 1 gram/day at last outpatient clinic visit
- Contra-indications for use of everolimus according to the opinion of the treating physician
- Additional for part 2: Herpes zoster vaccination with the live attenuated vaccine (Zostavax) or varicella vaccination (Provarivax) during the conduct of the study
- Additional for part 2: Previous herpes zoster vaccination with the RZV
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.