Treatment of chronic infections caused by hepatitis C virus genotype 1 strains MedDRA version: 8.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Product Name: ChronVac-C
Product Code: n.a.
Pharmaceutical Form: Solution for injection
Sponsors
Tripep AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient 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). 2. Known genotype 1 infection. 3. Viral load equal to or less than 800.000 IU/mL. 4. BMI less than 30. 5. Considered probable that the deltoid muscles (left and right) of the patient 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 patient. 7. Patient legally competent and able to communicate effectively with the study personnel. 8. Patient 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator. 2. Patient having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator. 3. Patient having clinical or biochemical signs of cirrhosis. 4. Positive hepatitis B surface antigen (HBsAg). 5. Positive HIV antigen or antibody test. 6. Patient having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention. 7. Patient 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. 10. Treatment with systemic NSAID within 10 days of the first dose of study drug. 11. Immunization within 30 days of the first dose of the study drug. 12. Patient 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. 13. Prior treatment with DNA therapy. 14. Known allergy towards vaccines. 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 patient who is pregnant or breast feeding. 21. Female patient 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. Patient with a positive urine pregnancy test. 23. Male patient unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection. 24. Patient 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 determine safety and tolerability of the plasmid DNA vaccine CHRONVAC-C® administered i.m. in combination with electroporation using MedPulser® DDS at 3 different dose levels at 4 occasions with 4 weeks in between, in treatment naïve chronic HCV genotype 1 patients with a viral load of 800 000 IU/ml or less over a range of doses. ;Secondary Objective: To provide information regarding dose related anti-viral immune response (antibodies and IFN-gamma producing T cells) and dose related effect on viral load in treatment naïve chronic HCV genotype 1 patients with a viral load of 800 000 IU/ml or less for further clinical investigations in HCV infected patients.;Primary end point(s): • Local tolerance will be assessed at the clinic immediately after vaccination, 0.5 h, 2 h and 6 h after vaccination. The patient will inspect the site of injection once per day at home for additional 7 days (patient diary). The site of injection will also be checked at the follow-up visits (weeks 1, 2, 5, 6, 9, 10, 13, 14, 16, and 36). • Vital signs will be measured at the clinic before vaccination, 2 h and 6 h after vaccination. The patient will measure body temperature once per day at home for additional 7 days (patient diary). Vital signs are also assessed at the screening and follow-up visits (week 1, 2, 5, 6, 9, 10, 13, 14, 16, and 36). • AEs will be recorded after active questioning and spontaneous reporting by patient, starting in connection with the initial administration and throughout the study. • Routine analyses (blood) will be monitored in venous blood at screening, weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 36. At the vaccination visits blood samples will be collected before and 6 h after vaccination. At the follow-up visits, weeks 1, 5, 9, and 13 the venous blood routine analyses will be limited to; ASAT, ALAT, bilirubin and CK. • Routine analyses (urine) will be performed at screening, weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 36. At the vaccination visit | — |
Countries
Sweden
Outcome results
None listed