Clinical trial NCT00277576: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Keywords: DNA vaccine
immunotherapy
Hepatitis B Virus
Particle Mediated Epidermal Delivery
Lead sponsor: PowderMed
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 )

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

Primary outcomes:
measure: Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination
Secondary outcomes:
measure: The secondary endpoints will assess the effect of the Investigational Product on:
measure: immunological response to vaccine at each visit
measure: clinical response to vaccine at each visit
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin
country: Hong Kong
facility: 19/F Prince of Wales Hospital
city: Tai Po, N. T.
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taoyan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linko
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiangmai Hospital
Study officials:
affiliation: Prince of Wales Hospital
name: Henry LY Chan
role: PRINCIPAL_INVESTIGATOR
affiliation: Alice Ho Miu Ling Nethersole Hospital
name: Nancy Leung
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Hospital, Singapore
name: Seng Gee Lim
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Wan Cheng Chow
role: PRINCIPAL_INVESTIGATOR
affiliation: Cathay General Hospital
name: Sien-Sing Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital - Linko
name: I Shyan-Sheen
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharaj Nakorn Chiang Mai Hospital
name: Satawat Thongsawat
role: PRINCIPAL_INVESTIGATOR
affiliation: Siriraj Hospital
name: Tawesak Tandwandee
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Mary Hospital, Hong Kong
name: Man Fung Yuen
role: PRINCIPAL_INVESTIGATOR
References: