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

Phase 1

Completed

• Conditions: Chronic Hepatitis B

• Registration Number: NCT00277576
• Lead Sponsor: PowderMed

Brief Summary

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.

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-13
• Study First Submitted QC: 2006-01-13
• Study First Posted: 2006-01-16
• Study Completion: 2007-12
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-20
• Last Update Posted: 2008-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

19/F Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong

Cathay General Hospital; 🇨🇳 Taipei, Taiwan

Singapore General Hospital; 🇸🇬 Singapore, Singapore

Maharaj Nakorn Chiangmai Hospital; 🇹🇭 Chiang Mai, Thailand

National University Hospital; 🇸🇬 Singapore, Singapore

Chang Gung Memorial Hospital - Linko; 🇨🇳 Taoyan, Taiwan

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Alice Ho Miu Ling Nethersole Hospital; 🇭🇰 Tai Po, N. T., Hong Kong