Efficacy of HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease.

NCT03459521 | Completed

• 1 other identifier: HMT2
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cirrhotic patients have an increased risk of infections. In these patients is important to prevent hepatitis B virus (HBV) infection, as it may cause a deterioration of liver function. However, HBV vaccine efficacy in this group of patients is lower than in healthy population. Despite increasing standard doses to double doses or administering an accelerated pattern, the response to HBV vaccination remains suboptimal. For this reason, an alternative strategy may be using vaccines with novel adjuvants such as Fendrix® or the recombinant vaccine HBVAXPRO®. Aim: To assess the adjuvanted HBV vaccine (Fendrix ®) efficacy in patients with chronic liver disease and to understand the kinetics of anti-HBs titers over time in patients who respond to vaccination. Methods: Prospective and multicenter study. Serological markers of HBV will be assessed prospectively in consecutive patients with non-cirrhotic liver disease (permanent abnormal liver blood tests \> six months; elastogram ≥8 kilopascal (kPa); serum markers of fibrosis (APRI or FIB-4 ≥ F2); ultrasound changes suggesting chronic liver disease) and cirrhotic patients (diagnosed by liver biopsy and/or non-invasive methods: clinical, blood tests and ultrasound). Seronegative patients will receive four doses of Fendrix ® at 0,1, 2 and 6 months. Antibodies against HBV superficial antigen (anti-HBs) will be determined at 2 months +/- 10 days, six months and one year after having received the fourth dose of the vaccine (to see kinetics). The study will differentiate between responders and non-responders to the vaccine: adequate immunity to HBV will be defined as anti-HBs higher than \> 10mUI/mL (standard definition of seroconversion) and\> 100mUI/mL. Investigators will evaluate the factors that influence the response, kinetics and safety of the vaccination in patients with chronic liver disease and cirrhosis.

Conditions

Liver Disease Chronic; Hepatitis B Virus

Outcome Measures

Primary Outcomes (1)

• The proportion of individuals seroconverting with Hepatitis B surface antibody titres of > 10 and > 100 UI/ml.

  8 months

Secondary Outcomes (1)

• Number of Participants With Vaccine-Related Adverse Events as Assessed by CTCAE v4.0

  8 months

Other Outcomes (1)

• The durability of anti-HBs titers over time in patients who respond to vaccination.

  1 year

Study Arms (1)

Fendrix HBV vaccine or HBVaxpro 40

EXPERIMENTAL

Drug: Fendrix Fendrix suspension for injection GlaxoSmithKline Route of administration, dose regimen: Intra-muscular Dose: 20mcg of Hepatitis B Surface Antigen per vaccination at baseline, 1, 2 and 6 months. Drug: HBVaxpro 40 Sanofi Pasteur MSD Route of administration, dose regimen: Intra-muscular Dose: 40mcg of Hepatitis B Surface Antigen per vaccination at baseline, 1 and 6 months.

Biological: Fendrix or HBVAXPRO 40

Interventions

Fendrix or HBVAXPRO 40 BIOLOGICAL

To administer hepatitis B virus vaccines in patients with chronic liver disease that have not been previously vaccinated.

Fendrix HBV vaccine or HBVaxpro 40

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic liver disease patients -non-cirrhotic and cirrhotic- diagnosed by liver biopsy and / or non-invasive methods (by standard clinical, analytical and ultrasound crite-ria)
• Negative hepatitis B surface antigen (HBs Ag) and antibody to hepatitis B core antigen (anti-HBc).

You may not qualify if:

• Allergy to vaccine components (sodium chloride, aluminium phosphate)
• Active or past HBV infection
• Patients previously vaccinated against HBV (regardless of response)
• Child-Pugh C
• Conditions that cause immunosuppression (HIV infection, chronic renal failure, active neoplasia)
• Pregnancy or breastfeeding
• Non-immunized HAV infection.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona/Spain, 08221, Spain

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Fendrix

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Diana Horta

  Corporacion Parc Tauli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: March 9, 2018
• Study Start: September 1, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)