VACcination of LIver Transplantation Candidates

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults waiting for a liver transplant. They must be sent to an infection clinic as part of their check-up before the transplant. The study looks at how well vaccines work in these people.

Életkor

18 years or older

Nem

All sexes

A betegség stádiuma

Liver disease serious enough that the person is waiting for a liver transplant.

Korábbi kezelés

People cannot join if they had treatment that weakens the immune system, biotherapy, or more than 10 mg / day of prednisone (or similar) for more than 2 weeks in the 3 months before vaccination. For rituximab, the limit is 6 months. People also cannot join if they had polyvalent immunoglobulins in the 6 months before the blood tests, or anti-cancer chemotherapy in the 6 months before vaccination.

A részvétel fő kizáró okai

• Waiting for a transplant of more than one organ
• Spleen removed, or no spleen for a reason other than liver disease
• Living with HIV
• Another inherited or acquired immune weakness that could change how vaccines work
• Under legal protection or unable to give consent

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat csoportja

• Liver transplantation candidates

  Kezelés: Vaccine immunogenicity