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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

Interventions

  • Biological: HBV vaccine
    • Patients receive a second cycle of vaccination
  • Biological: HBV vaccine
    • Patients receive vaccination according to the guidelines.

Arms, Groups and Cohorts

  • Experimental: Second HBV vaccination cycle
    • Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg.
  • Active Comparator: Single dose of HBV vaccine
    • Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination

Clinical Trial Outcome Measures

Primary Measures

  • Post-vaccination serological response
    • Time Frame: At 35 ± 5 days after administration
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Juan Manual Pascasio Acevedo, MD, PhD, Study Director, Virgen del Rocío Hospital

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