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

SE Frey, M Houghton, S Coates, S Abrignani, D Chien… - Vaccine, 2010 - Elsevier
SE Frey, M Houghton, S Coates, S Abrignani, D Chien, D Rosa, P Pileri, R Ray
Vaccine, 2010Elsevier
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 …
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 subjects developed antibodies detectable by ELISA, CD81 neutralization and VSV/HCV pseudotype neutralization. There were no significant differences between vaccine groups in the number of responders and geometric mean titers for each of the three assays. All subjects developed lymphocyte proliferation responses to E1E2 and an inverse response to increasing amounts of antigen was noted.
CONCLUSIONS
The vaccine was safe and generally well-tolerated at each of the 3 dosage levels and induced antibody and lymphoproliferative responses. A larger study to further evaluate safety and immunogenicity is warranted.
Elsevier