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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00277576

Enrollment

Registered

2006-01-16

Start date

2006-01-31

Completion date

2007-12-31

Last updated

2008-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

DNA vaccine, immunotherapy, Hepatitis B Virus, Particle Mediated Epidermal Delivery

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 )

Interventions

BIOLOGICALppdpSC18 administered by PMED

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Hong Kong, Singapore, Taiwan, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026