drugset / Trial / NCT01070407

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

NCT01070407

Phase 1 Completed 41 enrolled ReiThera Srl University of Oxford · collab
Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2007-07
Primary completion
2010-08
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad6NSmut Unknown 5e+08 unknown Intramuscular
Subject Ad6NSmut Unknown 5e+09 unknown Intramuscular
Subject Ad6NSmut Unknown 2.5e+10 unknown Intramuscular
Subject Ad6NSmut Unknown 7.5e+10 unknown Intramuscular
Subject AdCh3NSmut Unknown 5e+08 unknown Intramuscular
Subject AdCh3NSmut Unknown 5e+09 unknown Intramuscular
Subject AdCh3NSmut Unknown 2.5e+10 unknown Intramuscular
Subject AdCh3NSmut Unknown 7.5e+10 unknown Intramuscular