HBV inmunization in patients with cirrhosis candidates for liver transplantation. MedDRA version: 14.1 Level: PT Classification code 10054130 Term: Hepatitis B immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10061890 Term: Organ transplant System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10019641 Term: Hepatic cirrhosis System Organ Class: 10019805 -
Conditions
Interventions
Trade Name: HBVAXPRO 40 mcg
Product Name: HBVAXPRO 40 micrograms
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis B virus surface antigen, recombinant
Other descriptive nam
Sponsors
Fundación FISEVI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cirrhotic patients over 18 years old, potential candidates for liver transplantation with an estimated wait time of more than 6 months, with indication to HBV vaccionation (HBsAg negative and anti-HBs negative), who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 ?g at 0, 1 and 2 months, and who have given their consent to participate in the study. 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 118 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Absolute contraindication to HBV vaccine. Medical history of allergy to any component of the vaccine. Chronic renal failure on hemodialysis. Presence of antibodies against Human Immunodeficiency Virus. Patients with seroconversion (anti-HBs ? 10 IU /ml) after the first three doses of vaccine. Lack of consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At 35 ± 5 days after administration of the first cycle of vaccination (0, 1 and 2 months). In order to identify non-responders. At 35 ± 5 days after administration of the 4th dose at month 6 (Standard scheme). At 35 ± 5 days after administration of the second cycle of vaccination (0, 1 and 2 months) (Experimental scheme). Serum extraction will coincide as much as possible with other blood determinations to control patient's disease.;Main Objective: To compare the response rate obtained with two different vaccionation schemes against HBV in cirrhotic patients potential candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 UI/ml) after three intramuscular doses of 40 ?g at 0, 1 and 2 months.;Secondary Objective: To evaluate the association of immunogenicity of two vaccination procedures with clinical variables: age, sex, tobacco, diabetes, weight, body mass index / obesity, presence of anti-HBc positive, etiological factors and severity (Child Pugh stage, index MELD) in cirrhosis.;Primary end point(s): Post-vaccination serological response measured by the titre of anti-HBs and the response rate (? 10 IU / ml). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Association of serological response to HBV vaccionation to other clinical variables: age, sex, etiology and severity of cirrhosis (according to Child Pugh score, MELD index),diabetes, tobacco, weight, index of body mass/obesity, presence of anti-HBc positive, local and general adverse effects of the vaccine.;Timepoint(s) of evaluation of this end point: Clinical variables (age, weight, etiology and severity of cirrhosis, diabetes, snuff, weight, body mass index, obesity, presence of anti-HBc positive) will be collected at baseline visit. Local and general adverse effects of the vaccine will be recorded during the patients follow-up visits. | — |
Countries
Spain
Contacts
Public ContactUnidad de Coordinación de Ensayos
Hospital Virgen del Rocío
Outcome results
None listed