Immunogenicity and efficacy of the vaccine against Hepatitis B virus in immunosuppressed patients antiHBc positive with low titers of anti-HBs. Assessment of clinical usefulness in preventing reactivation of HBV infection. - HEPBARE

Vall de Hebron Hospital0 sitesMay 28, 2015

Overview

No summary available.

Registry

who.int

Start Date

May 28, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Vall de Hebron Hospital

•1\) Age \> 18 year\-old.
•2\) Immunosuppressive therapy (corticosteroids, anticalcineurin, antagonists purines, mTOR inhibitors, monoclonal antibodies).
•3\) Past hepatitis B (HBsAg negative / positive antiHBc / undetectable HBV DNA) with anti\-HBs titers below 100 mIU/mL.
•4\) At the time of inclusion, the patient will grant consent to participate in the study.
•5\) No exclusion criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 80
•F.1\.3 Elderly (\>\=65 years) yes

•1\) Life expectancy of less than 6 months.
•2\) The following patients will be excluded due to the high risk of reactivation and the need for prophylactic treatment :
•\- AntiCD\-20 monoclonal antibody (Rituximab, Ofatumumab).
•\- Chemotherapy.
•\- Transplanted hematopoietic progenitors.
•3\) Patients with allergy to any component of the vaccine.
•4\) Patients who have previously received HBV vaccination.
•5\) Patients with occult hepatitis B (HBsAg negative / antiHBc positive /detectable HBV DNA ).
•6\) Patients on renal replacement therapy with dialysis.