search
Back to results

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

Primary Purpose

Hepatitis B, Cirrhosis, Awaiting Organ Transplant

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
HBV vaccine
HBV vaccine
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virgen del Rocío Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Second HBV vaccination cycle

Single dose of HBV vaccine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Association of serological response to HBV vaccination to etiology and severity of cirrhosis
Etiology and severity of cirrhosis
Association of serological response to HBV vaccination to diabetes presence
Diabetes
Association of serological response to HBV vaccination to body mass index
Body mass index
Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence
Presence of anti-Hepatitis B core antigen positive
Association of serological response to HBV vaccination to obesity
Obesity

Full Information

First Posted
June 18, 2013
Last Updated
May 8, 2018
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
search

1. Study Identification

Unique Protocol Identification Number
NCT01884415
Brief Title
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
Official Title
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
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 7, 2012 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Cirrhosis, Awaiting Organ Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Second HBV vaccination cycle
Arm Type
Experimental
Arm Description
Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg.
Arm Title
Single dose of HBV vaccine
Arm Type
Active Comparator
Arm Description
Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination
Intervention Type
Biological
Intervention Name(s)
HBV vaccine
Other Intervention Name(s)
HBVAXPRO 40µg HBV vaccine
Intervention Description
Patients receive a second cycle of vaccination
Intervention Type
Biological
Intervention Name(s)
HBV vaccine
Other Intervention Name(s)
HBVAXPRO 40µg HBV vaccine
Intervention Description
Patients receive vaccination according to the guidelines.
Primary Outcome Measure Information:
Title
Post-vaccination serological response
Description
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.
Time Frame
At 35 ± 5 days after administration
Secondary Outcome Measure Information:
Title
Association of serological response to HBV vaccination to etiology and severity of cirrhosis
Description
Etiology and severity of cirrhosis
Time Frame
After 6 months
Title
Association of serological response to HBV vaccination to diabetes presence
Description
Diabetes
Time Frame
After 6 months
Title
Association of serological response to HBV vaccination to body mass index
Description
Body mass index
Time Frame
At baseline
Title
Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence
Description
Presence of anti-Hepatitis B core antigen positive
Time Frame
At baseline
Title
Association of serological response to HBV vaccination to obesity
Description
Obesity
Time Frame
After 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Manual Pascasio Acevedo, MD, PhD
Organizational Affiliation
Virgen del Rocío Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Virgen del Rocío Hospital
City
Seville
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs