COVID-19VACCHEPANCT05079165
Covid Vaccination in Liver Transplantation
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mRNA anti-SARS-CoV2 vaccination in a cohort of high risk liver transplanted patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 30 Nov 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
- Adult, Older adult
Study population: Liver transplanted adult patients for > 6 months after transplantation
Who may be able to join
- Liver transplanted patients for > 6 months after transplantation
- Listed cirrhotic patients
- Age >18 years-old
- Consent for vaccination with mRNA vaccine
Who cannot join
- Vaccination with non mRNA anti-SARS-CoV-2 vaccine
- Expressed opposition to participation to the study
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service deChirurgie Générale Hépatique-Endocrinienne,et transplantation - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
François FAITOT, MD, PhD, 33 3.88 12 72 85, francois.faitot@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: EVALUATION OF THE RESPONSE TO mRNA SARS-CoV-2 VACCINE IN A COHORT OF LIVER TRANSPLANTED OR LISTED PATIENTS
The goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mRNA anti-SARS-CoV2 vaccination in a cohort of high risk liver transplanted patients.
Seroprevalence is a secondary objective in order to identify seronegative patients with a history of COVID-19 (ie who lost antibodies) and seropositive patients with no history of COVID-19.
Read more
The hypothesis is that the degree of immunosuppression is determinant on the seroconversion rate and therefore, although at higher risk of severe forms of COVID-19, liver transplanted patients have a lower chance of being protected after vaccination.
Seroconversion rate in previously seronegative and with no history of COVID-19 liver transplanted patients is the main evaluation criteria.
The factors associated with the absence of seroconversion will be identified as a potential tool to better adapt the vaccination strategy in this population.
The rate of seroconversion after the 1st dose will also be evaluated. Safety of the 1st and 2nd injection will be reported as well as their value to predict seroconversion.
A control group of patients listed for transplantation will also be included both in the seroprevalence and the seroconversion analysis.
Persistance of the antibodies in long-term after transplantation and after transplantation for the patients who have been vaccinated before transplantation will also be reported.
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Coronavirus Vaccine, COVID-19 Pandemic, COVID-19 Virus Disease, SARS-CoV-2 Infection, Solid organ transplant, mRNA vaccine, MODERNA, liver transplant, Serological testing, serological response, SARS-CoV-2 mRNA vaccine, Anti-SARS-CoV-2 IgG antibodies
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the serological response to the anti-SARS-CoV-2 mRNA vaccine
Measured: Files analysed retrospectively from January 18, 2020 to April 30, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Jun 2021
- Primary completionMar 2022 (estimated)
- Study completion30 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 University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079165
- Sponsor's protocol ID
- 8261
- Acronym
- VACCHEPA
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE RESPONSE TO mRNA SARS-CoV-2 VACCINE IN A COHORT OF LIVER TRANSPLANTED OR LISTED PATIENTS
- ClinicalTrials.gov ID
- NCT05079165
- Acronym / sponsor ID
- VACCHEPA / 8261
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Coronavirus Vaccine, COVID-19 Pandemic, COVID-19 Virus Disease, SARS-CoV-2 Infection, Solid organ transplant, mRNA vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 15 Oct 2021 (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.
The goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mRNA anti-SARS-CoV2 vaccination in a cohort of high risk liver transplanted patients.
Seroprevalence is a secondary objective in order to identify seronegative patients with a history of COVID-19 (ie who lost antibodies) and seropositive patients with no history of COVID-19.
The hypothesis is that the degree of immunosuppression is determinant on the seroconversion rate and therefore, although at higher risk of severe forms of COVID-19, liver transplanted patients have a lower chance of being protected after vaccination.
Seroconversion rate in previously seronegative and with no history of COVID-19 liver transplanted patients is the main evaluation criteria.
The factors associated with the absence of seroconversion will be identified as a potential tool to better adapt the vaccination strategy in this population.
The rate of seroconversion after the 1st dose will also be evaluated. Safety of the 1st and 2nd injection will be reported as well as their value to predict seroconversion.
A control group of patients listed for transplantation will also be included both in the seroprevalence and the seroconversion analysis.
Persistance of the antibodies in long-term after transplantation and after transplantation for the patients who have been vaccinated before transplantation will also be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Liver transplanted adult patients for > 6 months after transplantation
Key inclusion criteria (4 listed)
- Liver transplanted patients for > 6 months after transplantation
- Listed cirrhotic patients
- Age >18 years-old
- Consent for vaccination with mRNA vaccine
Key exclusion criteria (2 listed)
- Vaccination with non mRNA anti-SARS-CoV-2 vaccine
- Expressed opposition to participation to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective description of the serological response to the anti-SARS-CoV-2 mRNA vaccine
Time frame: Files analysed retrospectively from January 18, 2020 to April 30, 2021 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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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.
Saïd CHAYER, PhD, HDR contact
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 COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
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 2 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 3 Feb 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François FAITOT, MD, PhD (33 3.88 12 72 85, francois.faitot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the serological response to the anti-SARS-CoV-2 mRNA vaccine (time frame: Files analysed retrospectively from January 18, 2020 to April 30, 2021 will be examined]). 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 3 Feb 2022.