Chronic Hepatitis C
Conditions
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.
Interventions
DRUGChronVac-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)
DRUGSOC
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)
Sponsors
Inovio Pharmaceuticals
ChronTech Pharma AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Known genotype 1 infection. * Viral load equal to 1000 IU/ml or more * BMI less than 35. * 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. * Written informed consent obtained, and a copy provided to the subject. * Subject legally competent and able to communicate effectively with the study personnel. * Subject likely to co-operate and attend the clinic at the appointed times during the study
Exclusion criteria
* Subject having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator. * Subject having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator. * Subject having clinical or biochemical signs of cirrhosis. * Positive hepatitis B surface antigen (HBsAg). * Positive HIV antigen or antibody test. * Subject having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention. * Subject having received previous treatment for HCV. * Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug. * 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.) * Immunization within 30 days of the first dose of the study drug. * 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. * Prior treatment with DNA therapy. * Known allergy towards vaccines. * Known allergy or contraindications to interferon and/or ribavirin or their excipients * Known abuse of alcohol, drugs or pharmaceuticals. * History, signs or symptoms of a cardiac disease. * Presence of an implantable pacemaker. * Any metal implants within the treatment areas (close to the right and/or left deltoid muscles). * Diagnoses of a serious psychiatric illness which may influence study participation. * Female subject who is pregnant or breast feeding. * 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. * Female subject with a positive urine pregnancy test. * Male subject unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response | 0 - 12 weeks | — |
| 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 | — |
Countries
Sweden
Contacts
Primary ContactOla RH Weiland, Professor
Outcome results
None listed