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

Phase 3

Completed

• Conditions: Cirrhosis; Awaiting Organ Transplant; Hepatitis B
• Interventions: Biological: HBV vaccine

• Registration Number: NCT01884415
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-07
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-24
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single dose of HBV vaccine	HBV vaccine	Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination
Second HBV vaccination cycle	HBV vaccine	Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg.

Primary Outcome Measures

Name	Time	Method
Post-vaccination serological response	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 Outcome Measures

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

Trial Locations

Locations (1)

Virgen del Rocío Hospital; 🇪🇸 Seville, Spain