Safety and Immunogenicity of HCV E1E2 Vaccine Adjuvanted with MF59 Administered to Healthy Adults
| Autor: | Jang H. Han, Paola Rinella, Ranjit Ray, Domenico Rosa, Michael Houghton, David Chien, Adrian M. Di Bisceglie, Viola Schultze, Heather Hill, Mark Wolff, Bruce F. Scharschmidt, Robert B. Belshe, Sharon E. Frey, Sergio Abrignani, Stephen R. Coates, Piero Pileri |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2010 |
| Předmět: |
Adult
CD4-Positive T-Lymphocytes Male Squalene Viral Hepatitis Vaccines Hepatitis C virus MF59 Polysorbates Lymphocyte proliferation Hepacivirus medicine.disease_cause Chronic liver disease Article Young Adult Adjuvants Immunologic Double-Blind Method medicine Humans Hepatitis Antibodies Adverse effect Immunization Schedule Cell Proliferation General Veterinary General Immunology and Microbiology business.industry Immunogenicity Public Health Environmental and Occupational Health Hepatitis C Middle Aged medicine.disease Virology Antibodies Neutralizing Vaccination Infectious Diseases Immunology Molecular Medicine Female business |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|