Under construction – not a live service
Sign in
Taking peopleNo phase

VACcination of LIver Transplantation Candidates

Key facts

Who runs it
Hospices Civils de Lyon
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
100 people, planned
Started
6 Jul 2020
Expected to end
6 Jul 2027
Type of study
Observational
Treatments tested
  • Vaccine immunogenicity
Record updated
9 November 2023

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • patient with any other hereditary immune deficiency or acquired which could compromise the vaccine response or interpretation of serological results
  • asplenic patients for a reason other than liver disease
  • chronic infection with the human immunodeficiency virus (HIV)
  • splenectomized patients
  • patient under legal protection measure or unable to consent to the study

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Liver transplantation candidates

    Treatment: Vaccine immunogenicity

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
VACcination of LIver Transplantation Candidates: Efficacy, Tolerance and Acceptability Prospective Cohort Study.
Record updated
9 November 2023