VACcination of LIver Transplantation Candidates

Status Recruiting

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04446832
Study type	Observational
Source	Hospices Civils de Lyon
Contact	Florent VALOUR, Dr
Phone	04 72 07 11 07
Email	florent.valour@chu-lyon.fr
Status	Recruiting
Phase
Start date	July 6, 2020
Completion date	July 6, 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

VACcination of LIver Transplantation Candidates — VacLit

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms