CHRONVAC-C Study Followed by Standard of Care in Chronic Hepatitis C Virus (HCV) Subjects
Study Details
Study Description
Brief Summary
To explore the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m. in combination with electroporation followed by standard of care (SOC) in treatment naïve chronic HCV genotype 1 patients.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IMP_C/C IL28B C/C IL28B subjects to whom IMP will be administrated prior to SOC |
Drug: ChronVac-C + SOC
IMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days.
SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)
|
Active Comparator: SOC_C/C IL28B C/C IL28B subjects to whom only SOC will be administrated |
Drug: SOC
SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)
|
Experimental: IMP_non-C/C IL28B non-C/C IL28B subjects to whom IMP will be administrated prior to SOC |
Drug: ChronVac-C + SOC
IMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days.
SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)
|
Active Comparator: SOC_non-C/C IL28B non-C/C IL28B subjects to whom only SOC will be administrated |
Drug: SOC
SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)
|
Outcome Measures
Primary Outcome Measures
- Early viral kinetics - Second phase slope of viral decline [0-4 weeks after SOC onset]
- Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA. [4 weeks after SOC onset]
- Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA. [12 weeks after SOC onset]
- Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA. [12 weeks after SOC onset]
Secondary Outcome Measures
- Local tolerance [up to 12 weeks after SOC onset]
Local tolerance will be measured for subjects randomized to vaccination. Local tolerance will be measured 3 times during a time period of 2 h post vaccination. The site of injection will also be inspected at the following visits.
- Change from baseline in vital signs [0 - 12 weeks]
- Number of patients with AEs [12 weeks]
- Change of blood status from baseline [0 - 12 weeks]
- Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response [0 - 12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subject 18 - 65 years of age with a known chronic hepatitis C infection, being treatment naїve (that is not being earlier treated for HCV infection) and a planned start of standard of care within 12 weeks from screening.
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Known genotype 1 infection.
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Viral load equal to 1000 IU/ml or more
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BMI less than 35.
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Considered probable that the deltoid muscles (left and right) of the subject will be reached at vaccination using a 12.7 mm cannula for injection and a 15 mm applicator tip for electroporation.
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Written informed consent obtained, and a copy provided to the subject.
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Subject legally competent and able to communicate effectively with the study personnel.
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Subject likely to co-operate and attend the clinic at the appointed times during the study
Exclusion Criteria:
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Subject having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
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Subject having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
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Subject having clinical or biochemical signs of cirrhosis.
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Positive hepatitis B surface antigen (HBsAg).
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Positive HIV antigen or antibody test.
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Subject having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.
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Subject having received previous treatment for HCV.
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Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug.
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Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, IFN-alpha, IFN-beta, IFN-gamma within 4 weeks prior to the first dose of study drug. (Corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed, however not on the vaccination area.)
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Immunization within 30 days of the first dose of the study drug.
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Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study drug.
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Prior treatment with DNA therapy.
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Known allergy towards vaccines.
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Known allergy or contraindications to interferon and/or ribavirin or their excipients
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Known abuse of alcohol, drugs or pharmaceuticals.
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History, signs or symptoms of a cardiac disease.
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Presence of an implantable pacemaker.
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Any metal implants within the treatment areas (close to the right and/or left deltoid muscles).
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Diagnoses of a serious psychiatric illness which may influence study participation.
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Female subject who is pregnant or breast feeding.
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Female subject not clinically sterile (hysterectomy, tubal ligation or postmenopausal (amenorrhea > 1 year and FSH > 30 mU/ml) OR if not clinically sterile unwilling to use a reliable contraception method.
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Female subject with a positive urine pregnancy test.
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Male subject unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.
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Subject or their immediate families being an investigator or site personnel directly affiliated with this study. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital | Huddinge | Sweden | SE-141 86 | |
2 | Division of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of Östergötland | Linköping | Sweden | SE-581 85 |
Sponsors and Collaborators
- ChronTech Pharma AB
- Inovio Pharmaceuticals
Investigators
- Principal Investigator: Ola RH Weiland, Professor, I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden
- Study Chair: Anders G Vahlne, Professor, ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden
- Study Director: Matti Sällberg, Professor, ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CVC-202
- 2010-022960-10