VACcination of LIver Transplantation Candidates: Efficacy, Tolerance and Acceptability Prospective Cohort Study.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse
RECRUITING
Lyon
Contact Information
Primary
Florent VALOUR, Dr
florent.valour@chu-lyon.fr
04 72 07 11 07
Time Frame
Start Date: 2020-07-06
Estimated Completion Date: 2027-07-06
Participants
Target number of participants: 100
Treatments
Liver transplantation candidates
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov