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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-07

Study Completion Date

2017-12-31

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.

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Detailed Description

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Conditions

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Hepatitis B Cirrhosis Awaiting Organ Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Second HBV vaccination cycle

Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg.

Group Type EXPERIMENTAL

HBV vaccine

Intervention Type BIOLOGICAL

Patients receive a second cycle of vaccination

Single dose of HBV vaccine

Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination

Group Type ACTIVE_COMPARATOR

HBV vaccine

Intervention Type BIOLOGICAL

Patients receive vaccination according to the guidelines.

Interventions

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HBV vaccine

Patients receive a second cycle of vaccination

Intervention Type BIOLOGICAL

HBV vaccine

Patients receive vaccination according to the guidelines.

Intervention Type BIOLOGICAL

Other Intervention Names

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HBVAXPRO 40µg HBV vaccine HBVAXPRO 40µg HBV vaccine

Eligibility Criteria

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Inclusion Criteria

1. Cirrhotic patients, potential candidates for liver transplantation, with indication to HBV vaccination (HBsAg negative and anti-HBs negative).
2. 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.
3. Patients over 18 years old.
4. Negative pregnancy test.
5. Patients who have given their consent to participate in the study.

Exclusion Criteria

1. Absolute contraindication to HBV vaccine.
2. Medical history of allergy to any component of the vaccine.
3. Chronic renal failure on hemodialysis.
4. Presence of antibodies against Human Immunodeficiency Virus.
5. Patients with seroconversion (anti-HBs \> 10 IU /ml) after the first three doses of vaccine.
6. Lack of consent to participate in the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No