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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No. 2007-002901-33 |
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| Name | Class |
|---|---|
| Inovio Pharmaceuticals | INDUSTRY |
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The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected individuals with a low viral load. In addition the capability of the vaccine to induce an immune response and the effect on viral load will be studied. In order to increase the uptake of the vaccine the intra muscular injection is combined with electroporation, meaning that a brief electric field is applied to the injection site resulting in temporary pores in the cell membranes that allows the vaccine to enter the cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Low dose |
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| 2 | Other | Medium dose |
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| 3 | Other | High dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHRONVAC-C® | Drug | DNA vaccine, solution for injection, i.m. administration in combination with electroporation |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and tolerability of electroporation mediated i.m. delivery of CHRONVAC-C® in chronically HCV infected, treatment naive patients with low viral load. | From start of treatment to 24 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information regarding dose related anti-viral immune response and dose related effect on viral load. | From start of treatment to 24 weeks post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ola RH Weiland, Professor | I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden | Principal Investigator |
| Anders Vahlne, Professor | Tripep AB | Study Chair |
| Matti Sällberg, Professor | Tripep AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge | Stockholm | SE-141 86 | Sweden | |||
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| Department of Gastroenterology and Hepatology, Karolinska University Hospital, Solna |
| Stockholm |
| SE-171 76 |
| Sweden |