NCT01884415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

5.2 years

First QC Date

June 18, 2013

Last Update Submit

May 8, 2018

Conditions

Hepatitis BCirrhosisAwaiting Organ Transplant

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Association of serological response to HBV vaccination to etiology and severity of cirrhosis

    After 6 months

  • Association of serological response to HBV vaccination to diabetes presence

    After 6 months

  • Association of serological response to HBV vaccination to body mass index

    At baseline

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

    At baseline

  • Association of serological response to HBV vaccination to obesity

    After 6 months

Study Arms (2)

Second HBV vaccination cycle

EXPERIMENTAL

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

Biological: HBV vaccine

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

Biological: HBV vaccine

Interventions

HBV vaccineBIOLOGICAL

Patients receive a second cycle of vaccination

Also known as: HBVAXPRO 40µg HBV vaccine
Second HBV vaccination cycle

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virgen del Rocío Hospital

Seville, 41013, Spain

Location

Related Publications (1)

  • 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.

    PMID: 36963815DERIVED

MeSH Terms

Conditions

Hepatitis BFibrosis

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Juan Manual Pascasio Acevedo, MD, PhD

    Virgen del Rocío Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 24, 2013

Study Start

September 7, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

ES(1)