CHRONVAC-C Study Followed by Standard of Care in Chronic Hepatitis C Virus (HCV) Subjects
Phase 2
- Conditions
- Chronic Hepatitis C
- Interventions
- Drug: ChronVac-C + SOCDrug: SOC
- Registration Number
- NCT01335711
- Lead Sponsor
- ChronTech Pharma AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMP_C/C IL28B ChronVac-C + SOC C/C IL28B subjects to whom IMP will be administrated prior to SOC SOC_C/C IL28B SOC C/C IL28B subjects to whom only SOC will be administrated IMP_non-C/C IL28B ChronVac-C + SOC non-C/C IL28B subjects to whom IMP will be administrated prior to SOC SOC_non-C/C IL28B SOC non-C/C IL28B subjects to whom only SOC will be administrated
- Primary Outcome Measures
Name Time Method Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA. 4 weeks after SOC onset Early viral kinetics - Second phase slope of viral decline 0-4 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
Name Time Method 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 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.
Trial Locations
- Locations (2)
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital
🇸🇪Huddinge, Sweden
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
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital🇸🇪Huddinge, SwedenOla RH Weiland, ProfessorPrincipal Investigator