Safety and immunogenicity of HCV E1E2 vaccine adjuvanted with MF59 administered to healthy adults.

ABSTRACT:

Background

Hepatitis C virus (HCV) causes chronic liver disease that often leads to cirrhosis and hepatocellular carcinoma. In animal studies, chimpanzees were protected against chronic infection following experimental challenge with either homologous or heterologous HCV genotype 1a strains which predominate in the USA and Canada. We describe the first in humans clinical trial of this prophylactic HCV vaccine.

Methods

HCV E1E2 adjuvanted with MF59C.1 (an oil-in-water emulsion) was given at 3 different dosages on day 0 and weeks 4, 24 and 48 in a phase 1, placebo-controlled, dose escalation trial to healthy HCV-negative adults.

Results

There was no significant difference in the proportion of subjects reporting adverse events across the groups. Following vaccination sub

SUBMITTER: Frey SE 

PROVIDER: S-EPMC2923449 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature