Efficacy of the vaccine against Hepatitis B in patients under immunosuppressive treatment with past hepatitis B but low antibody titers. Assessment of the usefulness of developing higher antibody titers in the prevention of reactivation of hepatitis B.

Conditions: Patients under immunosuppressant therapy with past hepatitis B infection (HBsAg -/antiHBc +) but low antiHBs titers.
MedDRA version: 18.0Level: LLTClassification code 10058827Term: Hepatitis B reactivationSystem Organ Class: 100000004862
MedDRA version: 18.0Level: PTClassification code 10050542Term: Hepatitis B surface antigen negativeSystem Organ Class: 10022891 - Investigations
MedDRA version: 18.0Level: PTClassification code 10052328Term: Hepatitis B core antigen positiveSystem Organ Class: 10022891 - Investigations
MedDRA version: 18.0Level: LLTClassification code 10068384Term: Hepatitis immunizationSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-000557-21-ES

Lead Sponsor: Vall de Hebron Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

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.