prospective, randomized, controlled study evaluating the effect of conversion from tacrolimus treatment to mTor inhibitor-based immunosuppression + tacrolimus to boost conversion to positive SARS-CoV-2 serology after a fourth dose of the vaccine of SARS-CoV-2 mRNA in solid organ transplant recipients who have not previously responded.

A prospective, randomized, controlled trial assessing the effect of conversion from Tacrolimus-antimetabolite to Tacrolimus-mTor-inhibitors based immunosuppression to booster SARS-CoV-2-specific seroconversion after a fourth dose of SARS-CoV-2 mRNA vaccine in unresponsive Solid Organ Transplant recipients - TOR-VAX

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000617-13-ES

Enrollment

Registered

2022-03-04

Start date

2022-04-12

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seroconversion is evaluated after changing treatment from tacrolimus to tacrolimus + mTOR inhibitor in solid organ transplant patients who have not responded to the first three doses of the vaccine MedDRA version: 21.0 Level: PT Classification code 10080575 Term: Solid organ transplant System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Rapamune Pharmaceutical Form: Oral solution INN or Proposed INN: Sirolimus CAS Number: 53123-88-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Tr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient’s age = 18 years 2. Time of transplantation = 1 year 3. Negative or very weak (=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. Previous diagnosis of T-cell mediated or antibody-mediated rejection 2. Previous seroconversion after any SARS-CoV-2 vaccine. 3. Previous COVID-19 infection 4. Presence of HLA donor-specific antibodies 5. Active cancer excluding non-melanoma skin cancer 6. Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to compare whether, after conversion from tacrolimus treatment to tacrolimus + mTor inhibitor, seroconversion is achieved with a fourth dose of the mRA vaccine against SARS-COV-2 in patients who have not responded to the first three dose;Secondary Objective: •Differences in the percentage of patients with a positive memory T and B-cell immune responses assessed using functional immune assays one month after the 4th dose of the mRNA SARS-CoV-2 vaccines between groups. •Differences in the rates of patients with a diagnosis of COVID-19 one month after the 4th dose of the mRNA SARS-CoV-2 vaccine between groups. •Rate of mTor-inhibitor discontinuation one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Estimated glomerular filtration rate one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Urine protein to creatinine ratio one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Rate of de novo anti-HLA antibodies one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Rate of biopsy-proven acute rejection one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Rate of adverse events one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.;Primary end point(s): Difference in the percentage of patients with a positive humoral immune response one month after the 4th dose of the mRNA SARS-CoV-2 vaccine between groups.;Timepoint(s) of evaluation of this end point: Se hará una analítica previa a entrar en el estudio para confirmar la serología COVID negativa. Una semana después, y una vez confirmada la eligibilidad, se aleatoriazá al paciente a una rama de las dos ramas del tratamiento: Rama control o rama con cambio de tratamiento a tacrolimus + imtor Una vez asignada la rama de tratamiento, a los 30 dias se administrará la cuarta dosis de la vacuna de mRNA contra el SARS-COV-2. 30 dias depués de la administración se hará un control analítico a todos los pacientes para comprobar si ha hab	—

Measure

Time frame

Main Objective: The objective of the study is to compare whether, after conversion from tacrolimus treatment to tacrolimus + mTor inhibitor, seroconversion is achieved with a fourth dose of the mRA vaccine against SARS-COV-2 in patients who have not responded to the first three dose;Secondary Objective: •Differences in the percentage of patients with a positive memory T and B-cell immune responses assessed using functional immune assays one month after the 4th dose of the mRNA SARS-CoV-2 vaccines between groups. •Differences in the rates of patients with a diagnosis of COVID-19 one month after the 4th dose of the mRNA SARS-CoV-2 vaccine between groups. •Rate of mTor-inhibitor discontinuation one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Estimated glomerular filtration rate one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Urine protein to creatinine ratio one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Rate of de novo anti-HLA antibodies one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Rate of biopsy-proven acute rejection one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. •Rate of adverse events one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.;Primary end point(s): Difference in the percentage of patients with a positive humoral immune response one month after the 4th dose of the mRNA SARS-CoV-2 vaccine between groups.;Timepoint(s) of evaluation of this end point: Se hará una analítica previa a entrar en el estudio para confirmar la serología COVID negativa. Una semana después, y una vez confirmada la eligibilidad, se aleatoriazá al paciente a una rama de las dos ramas del tratamiento: Rama control o rama con cambio de tratamiento a tacrolimus + imtor Una vez asignada la rama de tratamiento, a los 30 dias se administrará la cuarta dosis de la vacuna de mRNA contra el SARS-COV-2. 30 dias depués de la administración se hará un control analítico a todos los pacientes para comprobar si ha hab

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Secondary

Measure	Time frame
Secondary end point(s): • Differences in the percentage of patients with a positive memory T and B-cell immune responses assessed using functional immune assays one month after the 4th dose of the mRNA SARS-CoV-2 vaccines between groups. • Differences in the rates of patients with a diagnosis of COVID-19 one month after the 4th dose of the mRNA SARS-CoV-2 vaccine between groups. • Rate of mTor-inhibitor discontinuation one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Estimated glomerular filtration rate one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Urine protein to creatinine ratio one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Rate of de novo anti-HLA antibodies one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Rate of biopsy-proven acute rejection one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Rate of adverse events one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.;Timepoint(s) of evaluation of this end point: An analysis will be done prior to entering the study to confirm the negative COVID serology. One week later, and once eligibility is confirmed, the patient will be randomized to one of the two treatment arms: Control arm or arm with change of treatment to tacrolimus + imtor. A week later, another control test will be done to check the drug levels in the blood. Once the treatment arm has been assigned, at 30 days, another analytical control will be carried out and the fourth dose of the mRNA vaccine against SARS-COV-2 will be administered. 30 days after administration, an analytical control will be carried out on all patients to check if there has been seroconversion and to check the rest of the secondary endpoints. Another 30 days later, this control will be repeated.	—

Measure

Time frame

Secondary end point(s): • Differences in the percentage of patients with a positive memory T and B-cell immune responses assessed using functional immune assays one month after the 4th dose of the mRNA SARS-CoV-2 vaccines between groups. • Differences in the rates of patients with a diagnosis of COVID-19 one month after the 4th dose of the mRNA SARS-CoV-2 vaccine between groups. • Rate of mTor-inhibitor discontinuation one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Estimated glomerular filtration rate one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Urine protein to creatinine ratio one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Rate of de novo anti-HLA antibodies one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Rate of biopsy-proven acute rejection one month after the 4th dose of the mRNA SARS-CoV-2 vaccine. • Rate of adverse events one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.;Timepoint(s) of evaluation of this end point: An analysis will be done prior to entering the study to confirm the negative COVID serology. One week later, and once eligibility is confirmed, the patient will be randomized to one of the two treatment arms: Control arm or arm with change of treatment to tacrolimus + imtor. A week later, another control test will be done to check the drug levels in the blood. Once the treatment arm has been assigned, at 30 days, another analytical control will be carried out and the fourth dose of the mRNA vaccine against SARS-COV-2 will be administered. 30 days after administration, an analytical control will be carried out on all patients to check if there has been seroconversion and to check the rest of the secondary endpoints. Another 30 days later, this control will be repeated.

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Countries

Spain

Contacts

Public ContactOriol Bestard

Hospital Universitari Vall d'Hebron

obestard@vhebron.netSPAIN9327460006219

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026