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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Cirrhosis; Awaiting Organ Transplant
• Intervention / Treatment: Biological: HBV vaccine; Biological: HBV vaccine

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41013
    • Virgen del Rocio Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Second HBV vaccination cycle; Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg.	Biological: HBV vaccine; Patients receive a second cycle of vaccination; Other Names: HBVAXPRO 40µg HBV vaccine; Biological: HBV vaccine; Patients receive vaccination according to the guidelines.; Other Names: HBVAXPRO 40µg HBV vaccine
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	Biological: HBV vaccine; Patients receive a second cycle of vaccination; Other Names: HBVAXPRO 40µg HBV vaccine; Biological: HBV vaccine; Patients receive vaccination according to the guidelines.; Other Names: HBVAXPRO 40µg HBV vaccine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Study Director: Juan Manual Pascasio Acevedo, MD, PhD, Virgen del Rocio Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2012
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 18, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Fibrosis; Hepatitis B; Hepatitis; Liver Cirrhosis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: HEPATOTRAS