Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis

Study Overview
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Brief Summary
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The objective of this clinical trial is to compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients. These patients must be candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml) after three intramuscular doses of 40 µg.

Official Title
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Open-label, Phase III, Randomized, Clinical Trial to Evaluate the Efficacy of Two Different Hepatitis B Virus (HBV) Vaccination Schemes in Patients With Hepatic Cirrhosis Candidates to Liver Transplantation

Conditions
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Hepatitis B, Cirrhosis, Awaiting Organ Transplant

Intervention / Treatment
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* Biological: HBV vaccine
* Biological: HBV vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cirrhotic patients, potential candidates for liver transplantation, with indication to HBV vaccination (HBsAg negative and anti-HBs negative). Patients under treatment with HBVAXPRO® who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 µg at 0, 1 and 2 months. Patients over 18 years old. Negative pregnancy test. Patients who have given their consent to participate in the study. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Second HBV vaccination cycle<br>Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg. | Biological: HBV vaccine<br>* Patients receive a second cycle of vaccination<br>* Other names: HBVAXPRO 40µg HBV vaccine;|
| Active Comparator: Single dose of HBV vaccine<br>Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination | Biological: HBV vaccine<br>* Patients receive vaccination according to the guidelines.<br>* Other names: HBVAXPRO 40µg HBV vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-vaccination serological response | To compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients potential candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml) after three intramuscular doses of 40 µg at 0, 1 and 2 months. | At 35 ± 5 days after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of serological response to HBV vaccination to etiology and severity of cirrhosis | Etiology and severity of cirrhosis | After 6 months | 
| Association of serological response to HBV vaccination to diabetes presence | Diabetes | After 6 months | 
| Association of serological response to HBV vaccination to body mass index | Body mass index | At baseline | 
| Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence | Presence of anti-Hepatitis B core antigen positive | At baseline | 
| Association of serological response to HBV vaccination to obesity | Obesity | After 6 months |