HSV Vaccine

Herpes simplex virus type 2 (HSV-2) is the cause of genital herpes. The hallmark of herpesvirus infections is the establishment of a lifelong, latent infection that can reactivate to cause one or more rounds of disease. HSV-2 is a highly prevalent disease – and approximately 20-25% of individuals in developed countries are infected, with most experiencing painful periodic disease. In the USA, for example, from 40 to 60 million people are HSV-2-infected, with an incidence of 1-2 million new infections and 600,000–800,000 clinical cases per year. Prevalence in the 30-40 year-old population is about 30%, and is higher in women compared with men.

There is a significant medical need for prevention and treatment of HSV-2. There are no licensed vaccines currently available, and therapeutic treatment requires repeated dosing with antiviral products. AlphaVax is developing prophylactic and therapeutic alphavaccine products focused on the sexually transmitted form of HSV. These products are leveraged by 6 years of preclinical work showing excellent prophylactic protection in animal models as well as the ability to reduce HSV reactivation and disease severity in state-of-the-art therapeutic disease models. A successful prophylactic vaccine product is expected to require the induction of both antibody and T-cells, which makes HSV an ideally suited target for our alphavaccine platform.

Based on successful preclinical work which is now published, AlphaVax is advancing an HSV alphavaccine into clinical testing early in 2010. Following phase 1 safety and immunogenicity trials, a phase 2 proof-of-concept trial may be carried out in "discordant couples" which should provide an early indication of efficacy.