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

Primary Purpose

Chronic Hepatitis B

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

ppdpSC18 administered by PMED

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring DNA vaccine, immunotherapy, Hepatitis B Virus, Particle Mediated Epidermal Delivery

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

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

Full Information

NCT ID

NCT00277576

First Posted

January 13, 2006

Last Updated

November 20, 2008

Sponsor

PowderMed

1. Study Identification

Unique Protocol Identification Number

NCT00277576

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

PowderMed

4. Oversight

5. 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.

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 )

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

ppdpSC18 administered by PMED

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

The secondary endpoints will assess the effect of the Investigational Product on:

Title

immunological response to vaccine at each visit

Title

clinical response to vaccine at each visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: