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Completed

NCT Number: NCT01884415

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

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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Key information

Conditions

Hepatitis B Awaiting Organ Transplant Blood-Borne Infections Cirrhosis Communicable Diseases DNA Virus Infections Digestive System Diseases Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Virgen del Rocío Hospital

Seville, 41013, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HBV vaccine

Biological

Patients receive a second cycle of vaccination

Other names: HBVAXPRO 40µg HBV vaccine

Primary outcomes

  1. Post-vaccination serological response

    Time frame: 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 outcomes

  1. Association of serological response to HBV vaccination to etiology and severity of cirrhosis

    Time frame: After 6 months

    Etiology and severity of cirrhosis

  2. Association of serological response to HBV vaccination to diabetes presence

    Time frame: After 6 months

    Diabetes

  3. Association of serological response to HBV vaccination to body mass index

    Time frame: At baseline

    Body mass index

  4. Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence

    Time frame: At baseline

    Presence of anti-Hepatitis B core antigen positive

  5. Association of serological response to HBV vaccination to obesity

    Time frame: After 6 months

    Obesity

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 24, 2013
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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