NCT01094873

Study of a Novel Therapeutic Vaccine for Hepatitis C Virus

A Phase I Study to Assess the Safety and Immunogenicity of Ad6NSmut and AdCh3NSmut in Patients With Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: ReiThera Srl · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
BIOLOGICAL	AdCh3NSmut	Genetic vaccines against Hepatitis C virus infection
BIOLOGICAL	Ad6NSmut	Genetic vaccine against Hepatitis C virus infection

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-03-29
• Last updated: 2015-04-23

Locations

2 sites across 1 country: United Kingdom