Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection

Phase I, Multi-Centre, Randomised, Placebo-Controlled, Dose Escalation Study to Assess Local & Systemic Tolerability of Therapeutic DNA Plasmid pdpSC18 Vaccine Administered by Particle Mediated Epidermal Delivery Using PowderJect ND10 Delivery System in Subjects With Chronic Hepatitis B Infection

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to reduce hepatitis B disease.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Biological: ppdpSC18 administered by PMED

Detailed Description

Hepatitis B virus (HBV) is responsible for the most common form of parenterally transmitted viral hepatitis. It is estimated that approximately 350 million people worldwide are persistent carriers of the virus and it is a major cause of acute and chronic infections of the liver, with significant associated morbidity and mortality. Chronic infection occurs in 98% of new-born children infected by vertical transmission from the mother and in 5% of individuals infected after 2 years of age. About 25% of these subjects will progress to cirrhosis and 20% of this subgroup will develop hepatocellular carcinoma - one of the most common cancers world wide. HBV is a non-cytopathic virus and liver injury is mainly mediated by the host immune response against virus-infected liver cells and by the production of inflammatory cytokines. A vigorous, polyclonal and multispecific cytotoxic and helper T cell response to HBV is readily detectable in the peripheral blood of subjects with acute self-limited hepatitis B, but is weak, antigenically restricted (mono- or oligospecific) or undetectable in subjects with chronic infection. A vigorous T cell response is thus believed to be responsible for the elimination of the hepatitis B virus. The aim of a therapeutic vaccine would be to enhance natural responses by boosting the appropriate cellular immune response to HBV. The purpose of this study is to evaluate the safety and tolerability profile of the pPDPSC18 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Shatin, Hong Kong
    • 19/F Prince of Wales Hospital
  • Tai Po, N. T., Hong Kong
    • Alice Ho Miu Ling Nethersole Hospital
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
• Taiwan
  • Taipei, Taiwan, 106
    • Cathay General Hospital
  • Taoyan, Taiwan, 33
    • Chang Gung Memorial Hospital - Linko
• Thailand
  • Bangkok, Thailand
    • Siriraj Hospital
  • Chiang Mai, Thailand
    • Maharaj Nakorn Chiangmai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Otherwise healthy, treatment naïve subjects with chronic well compensated, eAg positive HBV infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination

Secondary Outcome Measures

Outcome Measure
The secondary endpoints will assess the effect of the Investigational Product on:
immunological response to vaccine at each visit
clinical response to vaccine at each visit

Collaborators and Investigators

• Sponsor: PowderMed
• Investigators: Principal Investigator: Henry LY Chan, Prince Of Wales Hospital; Principal Investigator: Nancy Leung, Alice Ho Miu Ling Nethersole Hospital; Principal Investigator: Seng Gee Lim, National University Hospital, Singapore; Principal Investigator: Wan Cheng Chow, Singapore General Hospital; Principal Investigator: Sien-Sing Yang, Cathay General Hospital; Principal Investigator: I Shyan-Sheen, Chang Gung Memorial Hospital - Linko; Principal Investigator: Satawat Thongsawat, Maharaj Nakorn Chiang Mai Hospital; Principal Investigator: Tawesak Tandwandee, Siriraj Hospital; Principal Investigator: Man Fung Yuen, Queen Mary Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: January 13, 2006
• First Submitted That Met QC Criteria: January 13, 2006
• First Posted (Estimate): January 16, 2006

Study Record Updates

• Last Update Posted (Estimate): November 21, 2008
• Last Update Submitted That Met QC Criteria: November 20, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: immunotherapy; Hepatitis B Virus; DNA vaccine; Particle Mediated Epidermal Delivery
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: PM HBV-001