Agenus announced statistically significant results from its Phase 2 study for HerpV, a recombinant therapeutic vaccine for the treatment of genital herpes caused by the herpes simplex virus-2 (HSV-2).
In this randomized, double-blind, multi-center study, a total of 80 patients with a history of 1–9 herpes recurrences 12 months prior to inclusion were randomized to receive the active treatment, HerpV and QS-21 Stimulon (n=70) or placebo (n=10). Three injections of HerpV or placebo were given at 2 week intervals with a 45 day genital swabbing period before and after the vaccination period. Patients were not on any antiviral treatments during their swabbing period.
A primary analysis looking at viral shedding after the initial three injections, shows that subjects who received HerpV had a statistically significant reduction in viral shedding (P=0.015; RR=0.85). These results suggest a 15% reduction in viral shedding after the initial treatment period before the administration of the booster injection. A reduction in viral load of 34% (P=0.08) was also observed. In the small group of subjects who received placebo there was no reduction in viral shedding (P=0.96).
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