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

This study has been completed.
Sponsor:
Information provided by:
PowderMed
ClinicalTrials.gov Identifier:
NCT00277576
First received: January 13, 2006
Last updated: November 20, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Chronic Hepatitis B
Biological: ppdpSC18 administered by PMED
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by PowderMed:

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

Estimated Enrollment: 48
Study Start Date: January 2006
Study Completion Date: December 2007
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 )

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277576

Locations
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., Hong Kong
Singapore
National University Hospital
Singapore, Singapore, 119074
Singapore General Hospital
Singapore, Singapore, 169608
Taiwan
Cathay General Hospital
Taipei, Taiwan, 106
Chang Gung Memorial Hospital - Linko
Taoyan, Taiwan, 33
Thailand
Siriraj Hospital
Bangkok, Thailand
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, Thailand
Sponsors and Collaborators
PowderMed
Investigators
Principal Investigator: Henry LY Chan Prince of Wales Hospital
Principal Investigator: Nancy Leung Alice Ho Miu Ling Nethersole Hospital
Principal Investigator: Seng Gee Lim National University Hospital, Singapore
Principal Investigator: Wan Cheng Chow Singapore General Hospital
Principal Investigator: Sien-Sing Yang Cathay General Hospital
Principal Investigator: I Shyan-Sheen Chang Gung Memorial Hospital - Linko
Principal Investigator: Satawat Thongsawat Maharaj Nakorn Chiang Mai Hospital
Principal Investigator: Tawesak Tandwandee Siriraj Hospital
Principal Investigator: Man Fung Yuen Queen Mary Hospital, Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00277576     History of Changes
Other Study ID Numbers: PM HBV-001
Study First Received: January 13, 2006
Last Updated: November 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by PowderMed:
DNA vaccine
immunotherapy
Hepatitis B Virus
Particle Mediated Epidermal Delivery

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 26, 2014