Chronic Hepatitis B, HBsAg, Hepatitis B VaccinePhase 3NCT03405597
HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg
A Phase 3 study testing Commercial Hepatitis B vaccine and Standard Treatment in people with Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine, run by Mahidol University at 1 site in Thailand.
Trial summary
Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine
- What is being tested?
- Commercial Hepatitis B vaccine and Standard Treatment
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteThailand
- Study dates
- 30 Mar 2017to 30 Jun 2018
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic Hepatitis B infection group
- 18-80 year-old
- Compensated liver disease
- Chronic HBV infection with or without NUCs treatment
- History of HBsAg positive > 6 months
- HBsAg negative with qualitative Elecsys (Roche) twice at least 6 months apart
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- HBsAb negative
- HBV DNA < 20 IU/mL
- Healthy group
- Healthy person without history of HBV vaccination (HBsAg, anti-HBc and HBsAb negative)
Who cannot join
- History of previous HBV vaccination
- Anti-HCV and/or anti-HIV positive
- Decompensated cirrhosis
- History of previous malignancies
- History or currently receive immunotherapy, cytotoxic or immunosuppressive agents
- Patient with immunodeficiency disease
Show all 9Show fewer
- Creatinine > 1.5 mg/dL
- Pregnancy or lactating woman
- Unable to consent
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Chairat Shayakul
About this study
Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion.
There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.
- Being tested
- Commercial Hepatitis B vaccine, Standard Treatment
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial Hepatitis B vaccineDrug
Also called Engerix B
Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6
Standard TreatmentOther
HBsAg, HBsAb test Ultrasound upper abdomen every 6 months
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Experimental | Commercial Hepatitis B vaccine Receives: Drug: Commercial Hepatitis B vaccine |
| Chronic hepatitis B with vaccination | Experimental | Commercial Hepatitis B vaccine Receives: Drug: Commercial Hepatitis B vaccine; Other: Standard Treatment |
| Chronic hepatitis B without vaccination | Active comparator | Standard treatment Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAb level at 4 weeks after complete vaccine injection
HBsAb level more than 10 mIU/ml at 7 months
Measured: an average of 7 months
Secondary outcomes (3)
HBsAb level at 6 months after complete vaccine injection
HBsAb level more than 10 mIU/ml at 6 months
Measured: an average of 1 year
Adverse event from HBV vaccine
Any adverse event from HBV vaccine by CTCAE v4.0
Measured: an average of 1 year
Factors associated with HBV vaccine response
Factors associated with HBV vaccine response at 12 months
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start30 Mar 2017
- Primary completion28 Feb 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis B, HBsAg, Hepatitis B VaccineStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tawesak Tanwandee, Principal investigator, Department of Medicine, Faculty of medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405597
- Sponsor's protocol ID
- 13/2560(EC1)
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Taheri H, Hasanjani Roushan MR, Soleimani Amiri MJ, Pouralijan M, Bijani A. Efficacy of Hepatitis B vaccine in those who lost Hepatitis B surface antigen during follow-up: Efficacy of HBV vaccine in those who lost HBsAg. Hepat Mon. 2011 Feb;11(2):119-22.
PubMed 22087128
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg
- ClinicalTrials.gov ID
- NCT03405597
- Acronym / sponsor ID
- 13/2560(EC1)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 23 Jan 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.
Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion.
There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | Experimental | Drug: Commercial Hepatitis B vaccineCommercial Hepatitis B vaccine |
| Chronic hepatitis B with vaccination | Experimental | Drug: Commercial Hepatitis B vaccine, Other: Standard TreatmentCommercial Hepatitis B vaccine |
| Chronic hepatitis B without vaccination | Active comparator | Other: Standard TreatmentStandard treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Chronic Hepatitis B infection group
- 18-80 year-old
- Compensated liver disease
- Chronic HBV infection with or without NUCs treatment
- History of HBsAg positive > 6 months
Key exclusion criteria (9 listed)
- History of previous HBV vaccination
- Anti-HCV and/or anti-HIV positive
- Decompensated cirrhosis
- History of previous malignancies
- History or currently receive immunotherapy, cytotoxic or immunosuppressive agents
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 |
|---|---|---|
| Commercial Hepatitis B vaccineAlso: Engerix BCommercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6 | Drug | Chronic hepatitis B with vaccination, Healthy control |
| Standard TreatmentHBsAg, HBsAb test Ultrasound upper abdomen every 6 months | Other | Chronic hepatitis B with vaccination, Chronic hepatitis B without vaccination |
Primary outcome
HBsAb level at 4 weeks after complete vaccine injection
Time frame: an average of 7 months
HBsAb level more than 10 mIU/ml at 7 months
3 secondary outcomes
HBsAb level at 6 months after complete vaccine injection
Time frame: an average of 1 year
Adverse event from HBV vaccine
Time frame: an average of 1 year
Factors associated with HBV vaccine response
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 22087128Taheri H, Hasanjani Roushan MR, Soleimani Amiri MJ, Pouralijan M, Bijani A. Efficacy of Hepatitis B vaccine in those who lost Hepatitis B surface antigen during follow-up: Efficacy of HBV vaccine in those who lost HBsAg. Hepat Mon. 2011 Feb;11(2):119-22.
- Individual participant dataSharing planned: Undecided
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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.
Tawesak Tanwandee principal investigator
Department of Medicine, Faculty of medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Commercial Hepatitis B vaccine and Standard Treatment in people with Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine, run by Mahidol University at 1 site in Thailand.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Jan 2018. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suppawat Jiraphairot (+66 877116517, suppawat_tu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAb level at 4 weeks after complete vaccine injection (time frame: an average of 7 months). 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 NCT03405597, 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 23 Jan 2018.