Treatment of chronic infections caused by hepatitis C virus genotype 1 strains MedDRA version: 13.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: ChronVac-C
Product Code: ChronVac-C
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ChronVac-C
Current Sponsor code: ChronVac-C
Concentration unit: µg/ml microgram(s)/mi
Sponsors
ChronTech Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject 18 – 65 years of age with a known chronic hepatitis C infection, being treatment na?ve (that is not being earlier treated for HCV infection) and a planned start of standard of care within 12 weeks from screening. 2. Known genotype 1 infection. 3. Viral load equal to 1000 IU/ml or more 4. BMI less than 35. 5. 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. 6. Written informed consent obtained, and a copy provided to the subject. 7. Subject legally competent and able to communicate effectively with the study personnel. 8. Subject likely to co-operate and attend the clinic at the appointed times during the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator. 2. Subject having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator. 3. Subject having clinical or biochemical signs of cirrhosis. 4. Positive hepatitis B surface antigen (HBsAg). 5. Positive HIV antigen or antibody test. 6. Subject having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention. 7. Subject having received previous treatment for HCV. 8. Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug. 9. 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.) 10. Immunization within 30 days of the first dose of the study drug. 11. 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. 12. Prior treatment with DNA therapy. 13. Known allergy towards vaccines. 14. Known allergy or contraindications to interferon and/or ribavirin or their excipients 15. Known abuse of alcohol, drugs or pharmaceuticals. 16. History, signs or symptoms of a cardiac disease. 17. Presence of an implantable pacemaker. 18. Any metal implants within the treatment areas (close to the right and/or left deltoid muscles). 19. Diagnoses of a serious psychiatric illness which may influence study participation. 20. Female subject who is pregnant or breast feeding. 21. 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. 22. Female subject with a positive urine pregnancy test. 23. Male subject unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection. 24. 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 |
|---|---|
| Main Objective: To explore the effect of 500 µg plasmid DNA vaccine CHRONVAC-C 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 on early viral kinetics and viral load in treatment naïve chronic HCV genotype 1 subjects with a viral load equal to 1 000 IU/ml or more for further clinical investigations in HCV infected subjects.;Secondary Objective: To determine safety, tolerability, and anti-viral immune response (antibodies and IFN-gamma producing T cells) of 500 µg plasmid DNA vaccine CHRONVAC-C 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, in treatment naïve chronic HCV genotype 1 subjects with a viral load equal to 1 000 IU/ml or more. ;Primary end point(s): • HCV-RNA kinetics. Second phase slope of viral decline during the initial 4 weeks of standard of care treatment (Week 2, Week 3 and Week 4) (measured using PCR). • Rapid Viral Response (RVR). After 4 weeks of standard of care; Percent subjects reaching non-detectable level of HCV-RNA (measured using PCR). • Partial Early Viral Response (pEVR). After 12 weeks of standard of care; Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA from standard of care initiation (Week 0) (measured using PCR). • Complete Early Viral Response (cEVR). After 12 weeks of standard of care; Percent subjects reaching non-detectable level of HCV-RNA (measured using PCR). The HCV-RNA kinetics will be based on analyses of frozen samples while RVR, pEVR, and cEVR will be based on analyses of fresh samples. ;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are specified in Section E.5.1 above. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Local tolerance will be assessed at the clinic immediately after vaccination, 0.5 h and 2 h after vaccination. The site of injection will also be checked at the following visits. • Vital signs will be measured at the clinic before vaccination and 2 h after vaccination. Vital signs are also assessed at Screening, 1st Vaccination (for subjects randomized to CHRONVAC-C treatment), 2nd Vaccination (for subjects randomized to ChronVA-C treatment), Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, and Week 12. • AEs will be recorded after active questioning and spontaneous reporting by subject throughout the study, starting in connection with 1st Vaccination for subjects randomized to CHRON-VAC-C treatment and in connection with initiation of SOC for subjects randomized to SOC alone. • General blood analyses will be monitored in venous blood at Screening, 1st Vaccination (for subjects randomized to CHRONVAC-C), 2nd Vaccination (for subjects randomized to CHRONVAC-C), Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, and Week 12. At the vaccination visits blood samples will be collected before vaccination. • Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response. At Screening, 1st Vaccination (for subjects randomized to CHRONVAC-C treatment), 1st Vaccination + 2 weeks (for subjects randomized to CHRONVAC-C treatment), 2nd Vaccination + 2 weeks (for subjects randomized to CHRONVAC-C treatment), Week 0, Week 2, Week 4, and Week 12. The following parameters will be analyzed in venous blood; - HCV NS3 specific antibody levels - Activation of NS3/4A-specific T cells ;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are specified in Section E. 5.2 above. | — |
Countries
Sweden
Contacts
Public ContactCVC-202 clinical trial information
Semcon Drug Development Consulting
Outcome results
None listed