Liver Transplant; ComplicationsVacLitNCT04446832
VACcination of LIver Transplantation Candidates
An observational study of Liver Transplant; Complications and Vaccination; Complications, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Chronic hepatic disease, and especially cirrhosis, are associated to a global dysfunction of the immune system. Liver transplantation represents the only replacement therapy for end-stage liver disease and a curative means of localized hepatocellular carcinoma (HCC) but required immunosuppressive treatment to limit… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Vaccination; Complications, Cirrhosis
- What is being tested?
- Vaccine immunogenicity
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2020to 6 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 transplantation candidates
Who may be able to join
- age ≥ 18 years old
- patients waiting for liver transplantation referred by hepato-gastroenterology department as part of the pre-transplant evaluation to the infectiology consultation
- patient who were informed of the study and did not object to participate
Who cannot join
- patient candidate for multi-organ transplant
- patient who received immunosuppressive therapy, biotherapy and/ or corticosteroid therapy at a dose greater than 10 mg / day of prednisone equivalent for more than 2 weeks within 3 months before vaccination (6 months of rituximab)
- patient who received polyvalent immunoglobulins within the 6 months before the serological evaluation
- patient who received systemic anti-cancer chemotherapy for solid tumor or hemopathy within 6 months preceding the start of vaccination
- splenectomized patients
- asplenic patients for a reason other than liver disease
Show all 9Show fewer
- chronic infection with the human immunodeficiency virus (HIV)
- patient with any other hereditary immune deficiency or acquired which could compromise the vaccine response or interpretation of serological results
- patient under legal protection measure or unable to consent to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse
Lyon, 69317
Florent VALOUR, Dr, 04 72 07 11 07 ext. +33, florent.valour@chu-lyon.fr
About this study
Official title: VACcination of LIver Transplantation Candidates: Efficacy, Tolerance and Acceptability Prospective Cohort Study.
Chronic hepatic disease, and especially cirrhosis, are associated to a global dysfunction of the immune system. Liver transplantation represents the only replacement therapy for end-stage liver disease and a curative means of localized hepatocellular carcinoma (HCC) but required immunosuppressive treatment to limit the risk of rejection. Candidates for liver transplantation are at an increased risk for severe infections, some of which can be prevented by vaccination. With regard to vaccine preventable diseases, these patients share the same pitfalls than all immunocompromised individuals: i) a theoretical or proven increased incidence and severity of certain infections warranting specific vaccine recommendations; ii) a decrease in immunogenicity of vaccine; iii) a risk of developing vaccine disease after administration of live attenuated vaccines. It is therefore recommended for all patients awaiting liver transplantation: i) updating the vaccinations recommended in general population (DTPw, MMR); ii) vaccination against viral hepatitis A and B to limit the risk of severe hepatitis; iii) vaccination against pneumococcal infection, influenza and chickenpox more common and more serious in this population. However, these recommendations are based on theoretical assessments and experts opinions; i) immunogenicity of vaccination in cirrhotic patients and persistence of post-transplant protection had been poorly assessed as well as their determinants; ii) there are only a few data regarding the tolerance of vaccinations in this population; iii) vaccination coverage of patients with end-stage liver disease is poorly known in France and; iv) the perception and acceptability of vaccinations have not been evaluated in this population.
Investigators hypothesis is that: the vaccination schedule currently recommended for liver transplantation does not provide adequate protection against vaccine targets 6 months after liver transplantation.
- Being tested
- Vaccine immunogenicity
- Medical subject headings
- Fibrosis, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine immunogenicityOther
Evaluation of the vaccine immunogenicity by standard approved serological tests
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation candidates | Not described Receives: Other: Vaccine immunogenicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of vaccine " responder " according to serological results measured 6 months after liver transplantation
Vaccine immunogenicity will be assess by titration of specific antibodies by standard approved serological tests and patients will be considered if their antibody title exceed protection threshold defined by the WHO and support by the literature when available (for example for tetanus or diphtheria vaccines), or a 4-fold increase in antibody titers compared to antibodies titers measures before vaccination when a protection threshold is not formally defined (for example for pneumococcus vaccination)
Measured: 6 months after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start6 Jul 2020
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446832
- Sponsor's protocol ID
- 69HCL19_0752
- Acronym
- VacLit
- Status last verified
- Nov 2023
- First submitted
- 22 Jun 2020
- Last updated
- 9 Nov 2023
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VACcination of LIver Transplantation Candidates: Efficacy, Tolerance and Acceptability Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04446832
- Acronym / sponsor ID
- VacLit / 69HCL19_0752
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 25 Jun 2020 (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.
Chronic hepatic disease, and especially cirrhosis, are associated to a global dysfunction of the immune system. Liver transplantation represents the only replacement therapy for end-stage liver disease and a curative means of localized hepatocellular carcinoma (HCC) but required immunosuppressive treatment to limit the risk of rejection. Candidates for liver transplantation are at an increased risk for severe infections, some of which can be prevented by vaccination. With regard to vaccine preventable diseases, these patients share the same pitfalls than all immunocompromised individuals: i) a theoretical or proven increased incidence and severity of certain infections warranting specific vaccine recommendations; ii) a decrease in immunogenicity of vaccine; iii) a risk of developing vaccine disease after administration of live attenuated vaccines. It is therefore recommended for all patients awaiting liver transplantation: i) updating the vaccinations recommended in general population (DTPw, MMR); ii) vaccination against viral hepatitis A and B to limit the risk of severe hepatitis; iii) vaccination against pneumococcal infection, influenza and chickenpox more common and more serious in this population. However, these recommendations are based on theoretical assessments and experts opinions; i) immunogenicity of vaccination in cirrhotic patients and persistence of post-transplant protection had been poorly assessed as well as their determinants; ii) there are only a few data regarding the tolerance of vaccinations in this population; iii) vaccination coverage of patients with end-stage liver disease is poorly known in France and; iv) the perception and acceptability of vaccinations have not been evaluated in this population.
Investigators hypothesis is that: the vaccination schedule currently recommended for liver transplantation does not provide adequate protection against vaccine targets 6 months after liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation candidates | – | Other: Vaccine immunogenicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplantation candidates
Key inclusion criteria (3 listed)
- age ≥ 18 years old
- patients waiting for liver transplantation referred by hepato-gastroenterology department as part of the pre-transplant evaluation to the infectiology consultation
- patient who were informed of the study and did not object to participate
Key exclusion criteria (9 listed)
- patient candidate for multi-organ transplant
- patient who received immunosuppressive therapy, biotherapy and/ or corticosteroid therapy at a dose greater than 10 mg / day of prednisone equivalent for more than 2 weeks within 3 months before vaccination (6 months of rituximab)
- patient who received polyvalent immunoglobulins within the 6 months before the serological evaluation
- patient who received systemic anti-cancer chemotherapy for solid tumor or hemopathy within 6 months preceding the start of vaccination
- splenectomized patients
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 |
|---|---|---|
| Vaccine immunogenicityEvaluation of the vaccine immunogenicity by standard approved serological tests | Other | Liver transplantation candidates |
Primary outcome
Proportion of vaccine " responder " according to serological results measured 6 months after liver transplantation
Time frame: 6 months after liver transplantation
Vaccine immunogenicity will be assess by titration of specific antibodies by standard approved serological tests and patients will be considered if their antibody title exceed protection threshold defined by the WHO and support by the literature when available (for example for tetanus or diphtheria vaccines), or a 4-fold increase in antibody titers compared to antibodies titers measures before vaccination when a protection threshold is not formally defined (for example for pneumococcus vaccination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Liver Transplant; Complications
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Active, not recruitingPhase 4
Semaglutide vs Sitagliptin
Liver Transplant; Complications, Diabetes Mellitus
RecruitingPhase 4
Extended-Release Tacrolimus Following Liver Transplantation
Liver Transplant; Complications, Renal Insufficiency
Active, not recruitingObservational study
Herpesvirus Immunology in Solid Organ Transplant Recipients - Liver Transplant Study
Cytomegalovirus Infections, Varicella Zoster Virus Infection
Recruiting
HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients
Liver Transplant; Complications
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.
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 Liver Transplant; Complications and Vaccination; Complications, run by Hospices Civils de Lyon 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Nov 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florent VALOUR, Dr (04 72 07 11 07 ext. +33, florent.valour@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of vaccine " responder " according to serological results measured 6 months after liver transplantation (time frame: 6 months after liver transplantation). 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 9 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.