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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.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Ad6NSmut; AdCh3NSmut, Ad6NSmut; AdCh3NSmut, Ad6NSmut; AdCh3NSmut, Ad6NSmut; AdCh3NSmut, AdCh3NSmut; Ad6NSmut, AdCh3NSmut; Ad6NSmut, AdCh3NSmut; Ad6NSmut, AdCh3NSmut; Ad6NSmut, Ad6NSmut; AdCh3NSmut, AdCh3NSmut; Ad6NSmut, AdCh3NSmut; Ad6NSmut
Azienda Ospedaliera Universitaria Federico II di Napoli
Published on BioPortfolio: 2014-08-27T03:15:50-0400
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