Ignite Creation Date:
2024-05-05 @ 10:22 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01094873
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2010-03-25
Brief Title:
Study of a Novel Therapeutic Vaccine for Hepatitis C Virus
Sponsor:
ReiThera Srl
Organization:
ReiThera Srl
Study Overview
Official Title:
A Phase I Study to Assess the Safety and Immunogenicity of Ad6NSmut and AdCh3NSmut in Patients With Hepatitis C Virus Infection
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HCV002TV is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus HCV in chronically infected patients The vaccine is based on the sequential delivery by intramuscular route of two different adenoviral vectors of chimpanzee and human origin respectively bearing the same genetic information for HCV antigens NS region
The two recombinant vaccine vectors called AdCh3NSmut and Ad6NSmut are weakened and unable to multiply within the body they are designed to induce an immune response against HCV proteins AdCh3NSmut and Ad6NSmut are being used in the ongoing HCV001 study in healthy volunteers with very good safety and immunogenicity results
HCV002TV is a dose-escalation study the AdCh3NSmut is administered as priming vaccination and Ad6NSmut as boosting vaccination
The trial includes
Arm A in which vaccinated patients are into Interferon-ribavirin therapy the gold standard therapy for hepatitis C
Arm B in which vaccinated patients are not into therapy
The two recombinant vaccine vectors called AdCh3NSmut and Ad6NSmut are weakened and unable to multiply within the body they are designed to induce an immune response against HCV proteins AdCh3NSmut and Ad6NSmut are being used in the ongoing HCV001 study in healthy volunteers with very good safety and immunogenicity results
HCV002TV is a dose-escalation study the AdCh3NSmut is administered as priming vaccination and Ad6NSmut as boosting vaccination
The trial includes
Arm A in which vaccinated patients are into Interferon-ribavirin therapy the gold standard therapy for hepatitis C
Arm B in which vaccinated patients are not into therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GTAC162 | OTHER | Gene Therapy Advisory Committee GTAC UK | None |
| 2008-006127-32 | EUDRACT_NUMBER | None | None |