Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg

NCT01817725 | Completed Phase 1 Results DMC

• 1 other identifier: ChangGungMH 101-3594A3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate chronic HBV infection in patients with low titer HBsAg.
2. 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. 3.To discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.

Conditions

Chronic Hepatitis B

Keywords

Therapeutic vaccine; HBsAg clearance; Immune clearance; HBsAg clearance induced by vaccination; s seroconversion in carriers after vaccination

Outcome Measures

Primary Outcomes (1)

• Change in HBsAg Levels From Baseline to 2 Years

  The difference of HBsAg levels at the end of follow up (2 years) and baseline

  2 years

Secondary Outcomes (1)

• Anti-HBs Seropositivity

  2 years

Study Arms (1)

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

Biological: HBV vaccine (Engerix B)

Interventions

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.

Engerix-B

Eligibility Criteria

• Age: 3 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Pregnancy
• Allergic to HBV vaccine or yeast.
• Hepatic decompensation

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan Xian, 33305, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 30088198 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is a pilot study. A control arm is not included. However, from literature review, natural HBsAg decay without seroconversion was around 0.054\~0.058 log IU/ml/year.

Results Point of Contact

• Title: Dr. Ming-Wei Lai
• Organization: Chang Gung Memorial Hospital, Linkou Branch

a22141@adm.cgmh.org.tw

886-3-3281200

Study Officials

• Ming-Wei Lai

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Chao-Wei Hsu

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Chau-Ting Yeh

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 25, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 2, 2017
• Results First Posted: May 2, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)