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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.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-000557-21-ES
Enrollment
Unknown
Registered
2015-05-28
Start date
2015-06-12
Completion date
Unknown
Last updated
2015-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients under immunosuppressant therapy with past hepatitis B infection (HBsAg -/antiHBc +) but low antiHBs titers. MedDRA version: 18.0 Level: LLT Classification code 10058827 Term: Hepatitis B reactivation System Organ Class: 100000004862 MedDRA version: 18.0 Level: PT Classification code 10050542 Term: Hepatitis B surface antigen negative System Organ Class: 10022891 - Investigations MedDRA version: 18.0 Level: PT Classification code 10052328 Term: Hepatitis B core antigen positive System

Interventions

Trade Name: HBVAXPRO Product Name: Recombinant Hepatitis B surface antigen Pharmaceutical Form: Suspension for injection

Sponsors

Vall de Hebron Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: Comparison of risk of Hepatitis B reactivation of immunosuppressed patients with past HBV infection who have received vaccination in contrast with a non-vaccinated control group, stratified by baseline antiHBs titers ( 100 mIU/mL after vaccination of immunosuppressed patients with past HBV infection (HBsAg - / antiHBc + /undetectable HBV DNA) and baseline low antiHBs titers. 2) Incidence of hepatitsi B reactivation in immunosuppressed patients with past HBV infection.;Timepoint(s) of evaluation of this end point: 1) 1 month after the administration of the last dose of HBV vaccine. 2) Follow-up during 2 years.—

Secondary

MeasureTime frame
Secondary end point(s): To contrast the incidence of hepatitis B reactivation in immunosuppresed patients with past hepatitis B who received vaccination in order to increase the antiHBs titers, in comparison with a non-vaccinated control group.;Timepoint(s) of evaluation of this end point: 2 years—

Countries

Spain

Contacts

Public ContactMar Riveiro

Vall de Hebron Hospital

mmriveir@vhebron.net0034932746140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026