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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277576
• Other study ID #: PM HBV-001
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2006
• Last updated: November 20, 2008
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: November 2008
• Source: PowderMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• ppdpSC18 administered by PMED

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
PowderMed

Countries where clinical trial is conducted

Hong Kong,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination
Secondary	The secondary endpoints will assess the effect of the Investigational Product on:
Secondary	immunological response to vaccine at each visit
Secondary	clinical response to vaccine at each visit