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A Study of a New Candidate Vaccine Against Hepatitis C Virus (HCV)

2014-08-27 03:15:50 | BioPortfolio

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Hepatitis C

Intervention

Ad6NSmut; AdCh3NSmut, Ad6NSmut; AdCh3NSmut, Ad6NSmut; AdCh3NSmut, Ad6NSmut; AdCh3NSmut, AdCh3NSmut; Ad6NSmut, AdCh3NSmut; Ad6NSmut, AdCh3NSmut; Ad6NSmut, AdCh3NSmut; Ad6NSmut, Ad6NSmut; AdCh3NSmut, AdCh3NSmut; Ad6NSmut, AdCh3NSmut; Ad6NSmut

Location

Azienda Ospedaliera Universitaria Federico II di Napoli
Napoli
Oxfordshire
Italy
80131

Status

Recruiting

Source

Okairos

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:50-0400

Clinical Trials [1 Associated Clinical Trials listed on BioPortfolio]

Study of a Novel Therapeutic Vaccine for Hepatitis C Virus

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 sequ...

PubMed Articles [0 Results]

None

Medical and Biotech [MESH] Definitions

None available.

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