Phase 1
N=20
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT01817725 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change in HBsAg Levels From Baseline to 2 Years — -0.27 log IU/ml — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- HBV vaccine (Engerix B) (Biological)
- Age
- Pediatric, Adult, Older Adult · 3+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HBsAg Levels From Baseline to 2 Years |
-0.27 | <0.05 sig |
| SECONDARY Anti-HBs Seropositivity |
2 | — |
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. 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
1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate chronic HBV infection in patients with low titer HBsAg.
2. 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.
3. To discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.
Eligibility Criteria
Inclusion Criteria
- 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;
Exclusion Criteria
- Pregnancy
- Allergic to HBV vaccine or yeast.
- Hepatic decompensation
Data sourced from ClinicalTrials.gov (NCT01817725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.