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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Second HBV vaccination cycle | Experimental | Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg. |
|
| Single dose of HBV vaccine | Active Comparator | Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBV vaccine | Biological | Patients receive a second cycle of vaccination |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Manual Pascasio Acevedo, MD, PhD | Virgen del Rocío Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virgen del Rocío Hospital | Seville | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36963815 | Derived | Giraldez-Gallego A, Rodriguez-Seguel EDP, Valencia-Martin R, Morillo-Garcia A, Salamanca-Rivera C, Ruiz-Perez R, Cuaresma-Duque M, Rosso-Fernandez C, Ferrer-Rios MT, Sousa-Martin JM, Praena-Fernandez JM, Desongles-Corrales T, Rodriguez-Perez A, Camino-Duran F, Gasch-Illescas A, Ampuero-Herrojo J, Pascasio-Acevedo JM. Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: an open-label randomised clinical trial. Gut. 2023 Dec 7;73(1):166-174. doi: 10.1136/gutjnl-2022-328222. |
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| HBV vaccine | Biological | Patients receive vaccination according to the guidelines. |
|
|
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 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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