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

NCT ID: NCT00277576

Last Updated: 2008-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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 )

Conditions

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Chronic Hepatitis B

Keywords

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DNA vaccine immunotherapy Hepatitis B Virus Particle Mediated Epidermal Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ppdpSC18 administered by PMED

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PowderMed

INDUSTRY

Sponsor Role lead

Principal Investigators

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Henry LY Chan

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital

Nancy Leung

Role: PRINCIPAL_INVESTIGATOR

Alice Ho Miu Ling Nethersole Hospital

Seng Gee Lim

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Wan Cheng Chow

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Sien-Sing Yang

Role: PRINCIPAL_INVESTIGATOR

Cathay General Hospital

I Shyan-Sheen

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital - Linko

Satawat Thongsawat

Role: PRINCIPAL_INVESTIGATOR

Maharaj Nakorn Chiang Mai Hospital

Tawesak Tandwandee

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Man Fung Yuen

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital, Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

19/F Prince of Wales Hospital

Shatin, , Hong Kong

Site Status

Alice Ho Miu Ling Nethersole Hospital

Tai Po, N. T., , Hong Kong

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Singapore General Hospital

Singapore, , Singapore

Site Status

Cathay General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital - Linko

Taoyan, , Taiwan

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, , Thailand

Site Status

Countries

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Hong Kong Singapore Taiwan Thailand

Other Identifiers

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PM HBV-001

Identifier Type: -

Identifier Source: org_study_id