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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00277576
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : November 21, 2008
Sponsor:
Information provided by:
PowderMed

Tracking Information
First Submitted Date  ICMJE January 13, 2006
First Posted Date  ICMJE January 16, 2006
Last Update Posted Date November 21, 2008
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2006)
Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00277576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection
Official Title  ICMJE 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
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 )
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis B
Intervention  ICMJE Biological: ppdpSC18 administered by PMED
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 13, 2006)
48
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Otherwise healthy, treatment naïve subjects with chronic well compensated, eAg positive HBV infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong,   Singapore,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00277576
Other Study ID Numbers  ICMJE PM HBV-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE PowderMed
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account PowderMed
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP