SARS-CoV-2 VaccinationNCT05490342
Effect of SARS-CoV-2 Vaccination in Liver Transplant Recipients
An observational study of SARS-CoV-2 Vaccination and Liver Transplantation, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
To investigate the variations in the humoral response to vaccines for the prevention of COVID-19 in liver transplant patients based on the type of immunosuppressive therapy adopted (tacrolimus based vs no-tacrolimus based) and immunosuppressive blood levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Vaccination, Liver Transplantation
- What is being tested?
- Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.
- Type of treatment
- Vaccines
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 30 Jun 2022
- Phase
- Observational
- 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
Study population: Liver transplant recipients who underwent SARS-CoV-2 vaccination (3 doses)
Who may be able to join
- Liver transplanted patients >18 years of age.
- Patients who underwent liver transplantation between 01/2015 to 12/2021.
- Patients who underwent liver transplantation at "Policlinico Tor Vergata, Rome, Italy".
- Patients who have had three doses of a vaccine for the prevention of COVID-19.
- Patients who have had three doses of a SARS-CoV-2 vaccine and who have contracted SARS-CoV-2 infection.
Who cannot join
- Patients who have more or less than three dose of a vaccine for the prevention of COVID-19
- Patients not vaccinated for prevention of SARS-CoV-2 infection.
- Patients who have had three doses of a vaccine for the prevention of COVID-19 prior to liver transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of SARS-CoV-2 Antibody Response After Vaccination in Liver Transplant Recipients Who Undergo Tailored Immunosuppression Therapy
To investigate the variations in the humoral response to vaccines for the prevention of COVID-19 in liver transplant patients based on the type of immunosuppressive therapy adopted (tacrolimus based vs no-tacrolimus based) and immunosuppressive blood levels.
- Conditions
- SARS-CoV-2 Vaccination, Liver Transplantation
- Being tested
- Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.Diagnostic test
Blood test to value the antibody response to vaccination
| Study group | Role | What they receive |
|---|---|---|
| tacrolimus-based immunosuppresion | The TAC-based group will include any patient on tacrolimus monotherapy and patients taking multiple IS medications with blood tacrolimus levels > 5 ng/mL Receives: Diagnostic Test: Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples. | |
| NON-tacrolimus-based immunosuppresion | The NON-TAC-based group will include any patient on TAC-free therapy and patient taking multiple IS medications with blood tacrolimus levels < 5 ng/mL Receives: Diagnostic Test: Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive antibody titer
> 0.8 U/mL
Measured: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
Secondary outcomes (2)
Rate of highly protective antibody titer
>100 BAU/mL
Measured: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
Median antibody titer absolute value
BAU/mL
Measured: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 VaccinationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Maria Manzia, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490342
- Sponsor's protocol ID
- sperimentazioni PTV 71.22
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- 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 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SARS-CoV-2 Antibody Response After Vaccination in Liver Transplant Recipients Who Undergo Tailored Immunosuppression Therapy
- ClinicalTrials.gov ID
- NCT05490342
- Acronym / sponsor ID
- sperimentazioni PTV 71.22
- Conditions
- SARS-CoV-2 Vaccination, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 5 Aug 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.
To investigate the variations in the humoral response to vaccines for the prevention of COVID-19 in liver transplant patients based on the type of immunosuppressive therapy adopted (tacrolimus based vs no-tacrolimus based) and immunosuppressive blood levels.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tacrolimus-based immunosuppresion | – | Diagnostic Test: Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.The TAC-based group will include any patient on tacrolimus monotherapy and patients taking multiple IS medications with blood tacrolimus levels > 5 ng/mL |
| NON-tacrolimus-based immunosuppresion | – | Diagnostic Test: Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.The NON-TAC-based group will include any patient on TAC-free therapy and patient taking multiple IS medications with blood tacrolimus levels < 5 ng/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant recipients who underwent SARS-CoV-2 vaccination (3 doses)
Key inclusion criteria (5 listed)
- Liver transplanted patients >18 years of age.
- Patients who underwent liver transplantation between 01/2015 to 12/2021.
- Patients who underwent liver transplantation at "Policlinico Tor Vergata, Rome, Italy".
- Patients who have had three doses of a vaccine for the prevention of COVID-19.
- Patients who have had three doses of a SARS-CoV-2 vaccine and who have contracted SARS-CoV-2 infection.
Key exclusion criteria (3 listed)
- Patients who have more or less than three dose of a vaccine for the prevention of COVID-19
- Patients not vaccinated for prevention of SARS-CoV-2 infection.
- Patients who have had three doses of a vaccine for the prevention of COVID-19 prior to liver transplantation.
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 |
|---|---|---|
| Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.Blood test to value the antibody response to vaccination | Diagnostic test | NON-tacrolimus-based immunosuppresion, tacrolimus-based immunosuppresion |
Primary outcome
Rate of positive antibody titer
Time frame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
> 0.8 U/mL
2 secondary outcomes
Rate of highly protective antibody titer
Time frame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
Median antibody titer absolute value
Time frame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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?
An observational study of SARS-CoV-2 Vaccination and Liver Transplantation, run by University of Rome Tor Vergata at 1 site in Italy.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 5 Aug 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of positive antibody titer (time frame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle). 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 5 Aug 2022.