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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase: Completed; Phase 3

Conditions: Cirrhosis; Hepatitis B; Awaiting Organ Transplant

Treatments: Biological: HBV vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01884415

HEPATOTRAS

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

112 participants in 2 patient groups

Second HBV vaccination cycle

Experimental group

Description:

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

Treatment:

Biological: HBV vaccine

Single dose of HBV vaccine

Active Comparator group

Description:

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

Treatment:

Biological: HBV vaccine