Ignite Creation Date:
2024-05-05 @ 10:19 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01070407
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2010-02-16
Brief Title:
A Study of a New Candidate Vaccine Against Hepatitis C Virus HCV
Sponsor:
ReiThera Srl
Organization:
ReiThera Srl
Study Overview
Official Title:
A Phase I Study to Assess the Safety and Immunogenicity of New Hepatitis C Virus Vaccine Candidates AdCh3NSmut and Ad6NSmut
Status:
COMPLETED
Status Verified Date:
2015-04
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:
HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus HCV The vaccine is based on the sequential delivery by intramuscular route of two different adenoviral vectors of human and chimpanzee origin respectively bearing the same genetic information for HCV antigens NS region
The two recombinant vectors called Ad6NSmut and AdCh3NSmut are weakened and unable to multiply within the body they are designed to induce an immune response against HCV proteins Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial promising results have been obtained in non-human studies
The HCV001 study is designed to explore different prime-boost regimes concerning dose order and interval of administration of Ad6NSmut and AdCh3NSmut
The two recombinant vectors called Ad6NSmut and AdCh3NSmut are weakened and unable to multiply within the body they are designed to induce an immune response against HCV proteins Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial promising results have been obtained in non-human studies
The HCV001 study is designed to explore different prime-boost regimes concerning dose order and interval of administration of Ad6NSmut and AdCh3NSmut
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 |
|---|---|---|---|
| 2007-004259-12 | EUDRACT_NUMBER | None | None |
| GTAC144 | OTHER | Gene Therapy Advisory Committee GTAC UK | None |