A Phase 1 interventional study of ppdpSC18 administered by PMED in Chronic Hepatitis B, sponsored by PowderMed. Completed at 9 sites in 4 countries. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2008-11-21.
Sponsored by PowderMed · Phase 1, Interventional, and Treatment
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.
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 )
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 48 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →PowderMed is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Otherwise healthy, treatment naïve subjects with chronic well compensated, eAg positive HBV infection
Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination
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
This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
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