Chronic Hepatitis BPhase 1NCT01817725
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
A Phase 1 study testing HBV vaccine (Engerix B) in people with Chronic Hepatitis B, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- HBV vaccine (Engerix B)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Feb 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Naïve or treated chronic hepatitis B patients with positive HBsAg and negative HBeAg;
- Quantitative serum HBsAg (qHBsAg) <2000 IU/ml;
- No HIV co-infection;
- No obvious immunodeficiency (such as renal failure, chemotherapy, radiotherapy, immunosuppressant);
- Aged 3 to 80 years;
Who cannot join
- Pregnancy
- Allergic to HBV vaccine or yeast.
- Hepatic decompensation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg-a Pilot Study
Background:
The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance. There is a good chance to further increase the cure rate if the investigators can enhance the HBV-specific immune response when the HBsAg level already comes to a low level.
Read more
Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients whose HBsAg already <=2000 IU/ml.
Patients and methods:
This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose during the treatment period and every 3 months for another year following the last dose. Viral and cellular factors will be studied to discover determinants affecting HBsAg clearance.
Aims
- To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate chronic HBV infection in patients with low titer HBsAg.
- To delineate the doses to response (HBsAg clearance or decline rate) correlation so as to design a feasible schedule for future clinical trials in a larger group of patients.
- To discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.
Read the detailed description
Vaccination schedule:
Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) will be administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months or until HBsAg clearance. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old.
HBsAg and anti-HBs:
qHBsAg will be checked by commercial kits (Elecsys, Roche Diagnostics, Indianapolis, IN) at baseline, right before every dose, and every 3 months following the last dose for one year. ALT, AST, Alpha-fetoprotein, bilirubin and anti-HBs will be checked simultaneously.
- Conditions
- Chronic Hepatitis B
- Being tested
- HBV vaccine (Engerix B)
- Keywords
- Therapeutic vaccine, HBsAg clearance, Immune clearance, HBsAg clearance induced by vaccination, s seroconversion in carriers after vaccination
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV vaccine (Engerix B)Biological
Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old.
| Study group | Role | What they receive |
|---|---|---|
| Engerix-B | Experimental | Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old Receives: Biological: HBV vaccine (Engerix B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HBsAg Levels From Baseline to 2 Years
The difference of HBsAg levels at the end of follow up (2 years) and baseline
Measured: 2 years
Secondary outcomes (1)
Anti-HBs Seropositivity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Wei Lai, Chang Gung Memorial Hospital
- Investigators
- Ming-Wei Lai, Principal investigator, Chang Gung Memorial HospitalChao-Wei Hsu, Principal investigator, Chang Gung Memorial HospitalChau-Ting Yeh, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817725
- Sponsor's protocol ID
- ChangGungMH 101-3594A3
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2013
- Last updated
- 2 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lai MW, Hsu CW, Lin CL, Chien RN, Lin WR, Chang CS, Liang KH, Yeh CT. Multiple doses of hepatitis B recombinant vaccine for chronic hepatitis B patients with low surface antigen levels: a pilot study. Hepatol Int. 2018 Sep;12(5):456-464. doi: 10.1007/s12072-018-9890-x. Epub 2018 Aug 7.
PubMed 30088198
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg-a Pilot Study
- ClinicalTrials.gov ID
- NCT01817725
- Acronym / sponsor ID
- ChangGungMH 101-3594A3
- Conditions
- Chronic Hepatitis B
- Keywords
- Therapeutic vaccine, HBsAg clearance, Immune clearance, HBsAg clearance induced by vaccination, s seroconversion in carriers after vaccination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Posted 2 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance. There is a good chance to further increase the cure rate if the investigators can enhance the HBV-specific immune response when the HBsAg level already comes to a low level.
Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients whose HBsAg already <=2000 IU/ml.
Patients and methods:
This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose during the treatment period and every 3 months for another year following the last dose. Viral and cellular factors will be studied to discover determinants affecting HBsAg clearance.
Aims
- To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate chronic HBV infection in patients with low titer HBsAg.
- To delineate the doses to response (HBsAg clearance or decline rate) correlation so as to design a feasible schedule for future clinical trials in a larger group of patients.
- To discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.
Detailed description
Vaccination schedule:
Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) will be administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months or until HBsAg clearance. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old.
HBsAg and anti-HBs:
qHBsAg will be checked by commercial kits (Elecsys, Roche Diagnostics, Indianapolis, IN) at baseline, right before every dose, and every 3 months following the last dose for one year. ALT, AST, Alpha-fetoprotein, bilirubin and anti-HBs will be checked simultaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Engerix-B | Experimental | Biological: HBV vaccine (Engerix B)Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Naïve or treated chronic hepatitis B patients with positive HBsAg and negative HBeAg;
- Quantitative serum HBsAg (qHBsAg) <2000 IU/ml;
- No HIV co-infection;
- No obvious immunodeficiency (such as renal failure, chemotherapy, radiotherapy, immunosuppressant);
- Aged 3 to 80 years;
Key exclusion criteria (3 listed)
- Pregnancy
- Allergic to HBV vaccine or yeast.
- Hepatic decompensation
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 |
|---|---|---|
| HBV vaccine (Engerix B)Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old. | Biological | Engerix-B |
Primary outcome
Change in HBsAg Levels From Baseline to 2 Years
Time frame: 2 years
The difference of HBsAg levels at the end of follow up (2 years) and baseline
1 secondary outcome
Anti-HBs Seropositivity
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30088198Lai MW, Hsu CW, Lin CL, Chien RN, Lin WR, Chang CS, Liang KH, Yeh CT. Multiple doses of hepatitis B recombinant vaccine for chronic hepatitis B patients with low surface antigen levels: a pilot study. Hepatol Int. 2018 Sep;12(5):456-464. doi: 10.1007/s12072-018-9890-x. Epub 2018 Aug 7.
- 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.
Ming-Wei Lai principal investigator
Chang Gung Memorial Hospital
Chao-Wei Hsu principal investigator
Chang Gung Memorial Hospital
Chau-Ting Yeh principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBV vaccine (Engerix B) in people with Chronic Hepatitis B, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 3 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 2 May 2017. 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 Taiwan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in HBsAg Levels From Baseline to 2 Years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817725, which also lists 1 linked publication.
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 2 May 2017.