Hepatitis B, Cirrhosis, Awaiting Organ Transplant
Conditions
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.
Interventions
BIOLOGICALHBV vaccine
Patients receive a second cycle of vaccination
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 diabetes presence | After 6 months | Diabetes |
| Association of serological response to HBV vaccination to body mass index | At baseline | Body mass index |
| 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 |
Countries
Spain
Outcome results
None listed