Liver Disease ChronicNCT03459521
Efficacy of HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease.
A study testing Fendrix or HBVAXPRO 40 in people with Liver Disease Chronic and Hepatitis B Virus, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease Chronic, Hepatitis B Virus
- What is being tested?
- Fendrix or HBVAXPRO 40
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona/Spain, 08221
About this study
Official title: Efficacy of Hepatitis B Virus Vaccines HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease in Clinical Practice.
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.
Read the detailed description
Intervention: Serological markers of HBV will be assessed prospectively in consecutive non-cirrhotic liver disease or cirrhotic patients. Seronegative patients willing to participate will sign a written informed consent and will receive four doses of 20 µg Fendrix ® at 0,1, 2 and 6 months or HBVAXPRO® at 0,1 and 6 months, depending on availability. Antibodies against HBV superficial antigen (anti-HBs) will be determined at 2 months +/- 10 days, six and twelve months after having received the fourth dose of the vaccine (to see kinetics). The study will differentiate between responders and nonresponders to the vaccine: adequate immunity to HBV will be defined as anti-HBs higher than > 10mUI/mL (standard definition of seroconversion) and > 100mUI/mL. Adverse events will be assessed throughout the treatment period.
- Conditions
- Liver Disease Chronic, Hepatitis B Virus
- Being tested
- Fendrix or HBVAXPRO 40
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fendrix or HBVAXPRO 40Biological
To administer hepatitis B virus vaccines in patients with chronic liver disease that have not been previously vaccinated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Fendrix or HBVAXPRO 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of individuals seroconverting with Hepatitis B surface antibody titres of > 10 and > 100 UI/ml.
Measured: 8 months
Secondary outcomes (1)
Number of Participants With Vaccine-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Sep 2017
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Disease ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Horta-Sangenis, Corporacion Parc Tauli
- Investigators
- Diana Horta, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459521
- Sponsor's protocol ID
- HMT2
- Status last verified
- Jul 2022
- First submitted
- 19 Jun 2017
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hepatitis B Virus Vaccines HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease in Clinical Practice.
- ClinicalTrials.gov ID
- NCT03459521
- Acronym / sponsor ID
- HMT2
- Conditions
- Liver Disease Chronic, Hepatitis B Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intervention: Serological markers of HBV will be assessed prospectively in consecutive non-cirrhotic liver disease or cirrhotic patients. Seronegative patients willing to participate will sign a written informed consent and will receive four doses of 20 µg Fendrix ® at 0,1, 2 and 6 months or HBVAXPRO® at 0,1 and 6 months, depending on availability. Antibodies against HBV superficial antigen (anti-HBs) will be determined at 2 months +/- 10 days, six and twelve months after having received the fourth dose of the vaccine (to see kinetics). The study will differentiate between responders and nonresponders to the vaccine: adequate immunity to HBV will be defined as anti-HBs higher than > 10mUI/mL (standard definition of seroconversion) and > 100mUI/mL. Adverse events will be assessed throughout the treatment period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fendrix HBV vaccine or HBVaxpro 40 | Experimental | Biological: Fendrix or HBVAXPRO 40Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fendrix or HBVAXPRO 40To administer hepatitis B virus vaccines in patients with chronic liver disease that have not been previously vaccinated. | Biological | Fendrix HBV vaccine or HBVaxpro 40 |
Primary outcome
The proportion of individuals seroconverting with Hepatitis B surface antibody titres of > 10 and > 100 UI/ml.
Time frame: 8 months
1 secondary outcome
Number of Participants With Vaccine-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Horta principal investigator
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fendrix or HBVAXPRO 40 in people with Liver Disease Chronic and Hepatitis B Virus, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of individuals seroconverting with Hepatitis B surface antibody titres of > 10 and > 100 UI/ml. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.