Intercell's therapeutic Hepatitis C vaccine safe in combination with standard therapy

14-Dec-2006

Intercell AG announced that it has completed a Phase II trial for its therapeutic hepatitis C vaccine (IC41), where the vaccine was applied in combination with the standard Hepatitis C therapy (pegylated interferon and Ribavirin - PegIFN-RBV) to patients infected with genotype 1. In the study, the vaccine administration was bound to the schedule of the first patient trial concluded in 2004 where route and frequency was still sub-optimal as compared to the improved induction of pivotal T-cells achieved in recently concluded optimization trial.

In the current clinical trial, chronically infected Hepatitis C patients receiving standard therapy with PegIFN-RBV were enrolled in Germany, Austria and in the UK. 22 patients who had an early response at week 12 to standard therapy received vaccinations with IC41 as an add-on to standard therapy during the second half of their treatment (week 28 to 48). The study proved a good safety profile of IC41 when used concomitantly with PegINF-RBV.

Furthermore, the level of the critical T-cell response generated was similar to what had been seen in previous studies in which chronic patients or healthy subjects were vaccinated with IC41 alone, indicating that there was no apparent interference of PegIFN-RBV with vaccine immunogenicity. Moreover, it was observed that critical anti-HCV T-cell responses could only be measured in the group of non-relapsing patients (14 out of 22), whereas such responses were absent in the 8 relapsing patients. As expected, however, an improved relapse rate by the concomitant use of IC41 could not be demonstrated with statistical significance, given the use of the non-optimized vaccination schedule.

https://www.bionity.com/en/news/60134/intercell-s-therapeutic-hepatitis-c-vaccine-safe-in-combination-with-standard-therapy.html