Chronic Hepatitis BPhase 1NCT00277576
Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection
A Phase 1 study testing ppdpSC18 administered by PMED in people with Chronic Hepatitis B, run by PowderMed at 9 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ppdpSC18 administered by PMED
- How many people
- 48 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Jan 2006to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Otherwise healthy, treatment naïve subjects with chronic well compensated, eAg positive HBV infection
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Hong Kong3 sites
Queen Mary Hospital
Hong Kong
19/F Prince of Wales Hospital
Shatin
Alice Ho Miu Ling Nethersole Hospital
Tai Po, N. T.
Singapore2 sites
National University Hospital
Singapore, 119074
Singapore General Hospital
Singapore, 169608
Taiwan2 sites
Cathay General Hospital
Taipei, 106
Chang Gung Memorial Hospital - Linko
Taoyan, 33
Thailand2 sites
Siriraj Hospital
Bangkok
Maharaj Nakorn Chiangmai Hospital
Chiang Mai
About this study
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
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.
Read the 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 )
- Conditions
- Chronic Hepatitis B
- Being tested
- ppdpSC18 administered by PMED
- Keywords
- DNA vaccine, immunotherapy, Hepatitis B Virus, Particle Mediated Epidermal Delivery
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ppdpSC18 administered by PMEDBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startJan 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PowderMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henry LY Chan, Principal investigator, Prince of Wales Hospital, Shatin, Hong KongNancy Leung, Principal investigator, Alice Ho Miu Ling Nethersole HospitalSeng Gee Lim, Principal investigator, National University Hospital, SingaporeWan Cheng Chow, Principal investigator, Singapore General HospitalSien-Sing Yang, Principal investigator, Cathay General HospitalI Shyan-Sheen, Principal investigator, Chang Gung Memorial Hospital - LinkoSatawat Thongsawat, Principal investigator, Maharaj Nakorn Chiang Mai HospitalTawesak Tandwandee, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277576
- Sponsor's protocol ID
- PM HBV-001
- Status last verified
- Nov 2008
- First submitted
- 13 Jan 2006
- Last updated
- 21 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00277576
- Acronym / sponsor ID
- PM HBV-001
- Conditions
- Chronic Hepatitis B
- Keywords
- DNA vaccine, immunotherapy, Hepatitis B Virus, Particle Mediated Epidermal Delivery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- PowderMedIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ppdpSC18 administered by PMED | Biological | – |
Primary outcome
Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2008.
Related trials for Chronic Hepatitis B
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry LY Chan principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
Nancy Leung principal investigator
Alice Ho Miu Ling Nethersole Hospital
Seng Gee Lim principal investigator
National University Hospital, Singapore
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ppdpSC18 administered by PMED in people with Chronic Hepatitis B, run by PowderMed at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Hong Kong, Singapore, Taiwan, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2008.