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

Sponsor

PowderMed (Industry)

Overall Status

Completed

CT.gov ID

NCT00277576

Collaborator

(none)

Enrollment

Locations

Duration (Months)

5.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Biological: ppdpSC18 administered by PMED	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2006

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Queen Mary Hospital	Hong Kong	Hong Kong
2	19/F Prince of Wales Hospital	Shatin	Hong Kong
3	Alice Ho Miu Ling Nethersole Hospital	Tai Po, N. T.	Hong Kong
4	National University Hospital	Singapore	Singapore	119074
5	Singapore General Hospital	Singapore	Singapore	169608
6	Cathay General Hospital	Taipei	Taiwan	106
7	Chang Gung Memorial Hospital - Linko	Taoyan	Taiwan	33
8	Siriraj Hospital	Bangkok	Thailand
9	Maharaj Nakorn Chiangmai Hospital	Chiang Mai	Thailand