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A Poxvirus Vaccine Is Safe, Induces T-Cell Responses, and Decreases Viral Load in Patients With Chronic Hepatitis C
Gastroenterology, 08/29/2011
Clinical Article
Habersetzer F et al. – In patients with chronic hepatitis C(CHC), the viral–vector–based vaccine TG4040 had a good safety profile, induced hepatitis C virus(HCV)–specific cellular immune responses, and reduced viral load. This vaccine should be investigated in further clinical studies, in combination with standard of care.
Methods- In an open-label, dose-escalating study, patients with mild CHC (genotype 1) were assigned to 3 groups of 3 patients each; they received subcutaneous injections of 106, 107, or 108 plaque-forming units of TG4040 on study days 1, 8, and 15.
- 6 additional patients were given the highest dose of vaccine (108 plaque-forming units).
- Patients were followed for 6 months after the last injection.
- T-cell–based and antibody responses and levels of HCV RNA were measured.
- All 3 doses of TG4040 were well tolerated, without serious adverse events.
- Vaccine-induced HCV-specific cellular immune responses were observed in 5 of the 15 patients (33%).
- A transient decrease in circulating levels of HCV RNA, from -0.52 log10 to -1.24 log10, was observed in 8 patients; in 5 patients, the lowest level of HCV RNA was observed on day 37, after the first injection.
- Most pronounced decrease in viral load occurred in 2 patients, who also had marked vaccine-induced T-cell responses.
