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

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

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.

Sponsors & Collaborators

• University of Oxford

  collaborator OTHER

• ReiThera Srl

  lead INDUSTRY

Principal Investigators

• Paul Klenerman, Professor · University of Oxford, UK

• David Adams, Professor · University of Birmingham

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2010-08-31

Completion

2011-02-28

Countries

• United Kingdom

Study Locations