NCT01070407

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

A Phase I Study to Assess the Safety and Immunogenicity of New Hepatitis C Virus Vaccine Candidates AdCh3NSmut and Ad6NSmut

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: ReiThera Srl · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
BIOLOGICAL	Ad6NSmut; AdCh3NSmut	2 doses Ad6NSmut 5 x 10\^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 24.
BIOLOGICAL	Ad6NSmut; AdCh3NSmut	2 doses Ad6NSmut 5 x 10\^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 24.
BIOLOGICAL	Ad6NSmut; AdCh3NSmut	2 doses Ad6NSmut 2.5 x 10\^10vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 24.
BIOLOGICAL	AdCh3NSmut; Ad6NSmut	2 doses AdCh3NSmut 5 x 10\^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10\^10vp at week 24.
BIOLOGICAL	AdCh3NSmut; Ad6NSmut	2 doses AdCh3NSmut 5 x 10\^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10\^10vp at week 24.
BIOLOGICAL	AdCh3NSmut; Ad6NSmut	2 doses AdCh3NSmut 2.5 x 10\^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10\^10vp at week 24.
BIOLOGICAL	Ad6NSmut; AdCh3NSmut	1 dose Ad6NSmut 2.5 x 10\^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 8.
BIOLOGICAL	AdCh3NSmut; Ad6NSmut	1 dose AdCh3NSmut 2.5 x 10\^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10\^10vp at week 8.
BIOLOGICAL	AdCh3NSmut; Ad6NSmut	1 dose AdCh3NSmut 7.5 x 10\^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10\^10vp at week 8.

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-08-01
• Completion: 2011-02-01
• First posted: 2010-02-18
• Last updated: 2015-04-23

Locations

2 sites across 1 country: United Kingdom