Chronic Hepatitis CPhase 1NCT00445419
Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides
A Phase 1 study testing PEV2A PEV2B in people with Chronic Hepatitis C, run by Pevion Biotech Ltd at 1 site in Switzerland.
Trial summary
Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- PEV2A PEV2B
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2006to Jun 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers of both sexes
- Aged between 18 and 45 years
- Free of obvious health problems
- With a BMI between 18.5 and 29.9 are included if they give written informed consent
Who cannot join
- Chronic or acute illness
- Immunosuppression
- HCV and/or HBV infection
- history of allergic disease
- Pre-existing immune response against peptide of the vaccines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Single-blind Randomised Placebo Controlled Dose Escalating Study of One Virosome Formulated CD4 and Two Virosomes Formulated CD8 Hepatitis C Virus (HCV) Vaccine Components (PEV2A and PEV2B) Administered to Healthy Adult Volunteers
Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together with a supportive helper T cell response (PeviPRO). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.
- Conditions
- Chronic Hepatitis C
- Being tested
- PEV2A PEV2B
- Keywords
- Hepatitis C, Liver disease, Viral infection, Virosome, Vaccine, therapeutic vaccine, Chronic hepatitis C virus infection
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Liver Diseases, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEV2A PEV2BBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Specific cellular immune response by Elispot and FACS
Secondary outcomes (2)
Specific proliferative response
Humoral immunity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startDec 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pevion Biotech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Giuseppe Pantaleo, MD, Principal investigator, Vaccine and Immunotherapy Center (VIC), Division of Immunology and Allergy, CHUV, Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445419
- Sponsor's protocol ID
- PHEPC001
- Other IDs
- 2006DR1345
- Status last verified
- Feb 2010
- First submitted
- 8 Mar 2007
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single-blind Randomised Placebo Controlled Dose Escalating Study of One Virosome Formulated CD4 and Two Virosomes Formulated CD8 Hepatitis C Virus (HCV) Vaccine Components (PEV2A and PEV2B) Administered to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00445419
- Acronym / sponsor ID
- PHEPC001
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Liver disease, Viral infection, Virosome, Vaccine, therapeutic vaccine, Chronic hepatitis C virus infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pevion Biotech LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Mar 2007 (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.
Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together with a supportive helper T cell response (PeviPRO). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers of both sexes
- Aged between 18 and 45 years
- Free of obvious health problems
- With a BMI between 18.5 and 29.9 are included if they give written informed consent
Key exclusion criteria (5 listed)
- Chronic or acute illness
- Immunosuppression
- HCV and/or HBV infection
- history of allergic disease
- Pre-existing immune response against peptide of the vaccines
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 |
|---|---|---|
| PEV2A PEV2B | Biological | – |
Primary outcome
Incidence of adverse events
Specific cellular immune response by Elispot and FACS
2 secondary outcomes
Specific proliferative response
Humoral immunity
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 8 Feb 2010.
- Click here for more information about this studyLink provided by the sponsor.
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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.
Giuseppe Pantaleo, MD principal investigator
Vaccine and Immunotherapy Center (VIC), Division of Immunology and Allergy, CHUV, Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEV2A PEV2B in people with Chronic Hepatitis C, run by Pevion Biotech Ltd at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Incidence of adverse events. The study lists 2 primary outcomes in all. 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 8 Feb 2010.