Actively Recruiting

Age: 18Years +
All Genders
NCT04446832

VACcination of LIver Transplantation Candidates

Led by Hospices Civils de Lyon · Updated on 2023-11-09

100

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

VACcination of LIver Transplantation Candidates

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Waiting for liver transplantation and referred by hepato-gastroenterology department for pre-transplant evaluation to infectious disease consultation
  • Informed about the study and did not object to participate
Not Eligible

You will not qualify if you...

  • Candidate for multi-organ transplant
  • Received immunosuppressive, biotherapy, or corticosteroid therapy above 10 mg/day prednisone equivalent for more than 2 weeks within 3 months before vaccination (6 months for rituximab)
  • Received polyvalent immunoglobulins within 6 months before serological evaluation
  • Received systemic anti-cancer chemotherapy for solid tumor or blood cancer within 6 months before vaccination
  • Splenectomized patients
  • Asplenic patients for reasons other than liver disease
  • Chronic HIV infection
  • Any hereditary or acquired immune deficiency that may affect vaccine response or serological interpretation
  • Under legal protection or unable to consent to the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse

Lyon, France, 69317

Actively Recruiting

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Research Team

F

Florent VALOUR, Dr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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