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Initial, positive results have been reported for a therapeutic vaccine candidate for treating patients with genital herpes. Wald and her team presented the initial findings of the first-in-human clinical trial of the novel GEN-003 T cell vaccine Sept. The vaccine contains, among other components, a proprietary adjuvant, trademarked Matrix-M. Genital herpes is one of the most common types of sexually transmitted infections (STI) in the United States – as well as one of the most frustrating. The discovery could lead to a vaccine capable of preventing herpes lesions on people who have already contracted the STI – or in other words, a vaccine that could “clinically cure” an individual of herpes symptoms.
The newly identified T-cells, called CD8??+ T-cells, reveal a great deal more information about genital herpes than was initially known. Before this study, researchers believed that herpes reactivation was controlled at the ganglion level of the spinal canal area.

Researchers had originally estimated that herpes reactivated once a month, but the discovery of these ever-present T-cells led Corey and his team to believe the virus actually reactivates once a week or every few days. The vaccine could potentially stop individuals from experiencing outbreaks – the times when a person is most contagious. According to the Centers for Disease Control and Prevention, 776,000 people in the United States are infected with herpes each year, and one out of six people between the ages of 14 and 49 have genital HSV-2 infection. Coridon’s herpes vaccine program has shown very positive animal data in clearing the virus, with longer term follow up data showing continued persistence of the immune response.
Results of the trial are due approximately in 1QCY14.Based on success to date, an effective vaccine for herpes looks to be within grasp, providing a grand prize for Allied Healthcare in potential revenue. This first-in-class, investigational, protein subunit vaccine, GEN-003, is under development by Genocea Biosciences Inc.
T cell vaccine research is trying to find safe, effective ways to spur this protective reaction.

However, an exploratory analysis suggested that the interval between the first immunization with GEN-003 and the next recurrence of genital herpes might be longer in those receiving the actual candidate vaccine, rather than the placebo injection. Wald is enrolling women infected with herpes simplex virus 2 in a study to see whether the drug tenofovir, given orally or as a vaginal gel, reduces genital shedding of the virus. Researchers have identified a subtype of immune cells that suppress outbreaks of genital herpes caused by the herpes simplex virus type 2 (HSV-2). While this vaccine would not cure those of HSV-2, it could ultimately help stop the spread of this very prevalent STI. Genocea, located near Boston, is a clinical-stage biopharmaceutical company for the discovery and development of T cell vaccines to prevent and treat infectious diseases.

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