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admin 01.09.2015

Genital herpes is a disease caused by the herpes simplex virus (HSV), of which there are two types. HSV-2 cannot survive long on a non-living surface, so there is no real risk of getting it from a toilet seat or hot tub, for example. Initial, positive results have been reported for a therapeutic vaccine candidate for treating patients with genital herpes. T cells, a type of white blood cells, generate immune responses to pathogens and are important in controlling infections. Wald and her team presented the initial findings of the first-in-human clinical trial of the novel GEN-003 T cell vaccine Sept.
Genocea plans to move into Phase 2 of this trial in 2014 to further evaluate GEN 003’s safety and effectiveness in a larger group of patients.
At unpredictable times in those carrying the infection, the herpes virus will come out of hiding and  surface on the genitals, sometimes producing blisters and discomfort, and sometimes arising without any noticeable symptoms.  This surfacing is called viral shedding. The results also demonstrated that immunization with GEN-003 is associated with activation of T cell immunity. The first-in-human clinical trial was not designed to test whether GEN-003 lessens symptoms or lowers how often a breakout occurs. Genocea developed the proprietary platform ATLAS, which can identify protective T cell antigens in people exposed to a pathogen. The vaccine contains, among other components, a proprietary adjuvant, trademarked Matrix-M.
Also known as a cold sore, this lesion is caused by the contagious herpes simplex virus Type-1 (HSV-1), and should not be confused with a canker sore, which is not contagious.


When it's active, it travels to the surface of the infected area (skin or mucous membrane) and makes copies of itself.
One reason may be that the virus can infect a woman's genitals more easily than it can a man's. HSV-1 can also spread from the mouth to the genitals during oral sex (fellatio, cunnilingus, analingus). But just as HSV-1 can infect the genitals and cause genital herpes, HSV-2 can pass from one person's genitals to another person's mouth, resulting in oral herpes. This first-in-class, investigational, protein subunit vaccine, GEN-003, is under development by Genocea Biosciences Inc. Anna Wald, University of Washington professor of medicine and laboratory medicine in the School of Medicine and professor of epidemiology in the School of Public Health, is among those leading clinical studies of GEN-003. David Koelle’s lab in the Division of Allergy and Infectious Diseases, Department of Medicine. T cell vaccine research is trying to find safe, effective ways to spur this protective reaction.
12 at a session of the Interscience Conference on Antimicrobials Agents and Chemotherapy in Denver.
The infection can provoke recurring episodes of painful genital sores.  An estimated 50 million to 60 million Americans are affected. In those receiving the vaccine candidate, T cell immune responses increased more than 20 times to one vaccine antigen and more than 10 times to another antigen.  The vaccine candidate also increased neutralizing antibodies to the herpes simplex 2 by five times greater than baseline amounts. 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. This is called "shedding" because these new viruses can, at this time, rub off on another person. Genital herpes is more common among blacks than it is among whites, and it becomes more common as people age. 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. Viral shedding is a marker both of the risk of recurrence and the transmission of infection. The adjuvant has a product that, in previous clinical studies, has been shown to stimulate B and T cell immune responses.
Reducing the frequency of viral shedding is the first step to showing that a drug can reduce outbreaks or, potentially, sexual transmission to partners.
In the past, HSV-1 was not known to cause genital herpes, but that is changing, especially among people who begin having sex at a young age. Then the virus travels back down the nerve to a ganglion (mass of nerve tissue), usually at the base of the spine, where it lies dormant for a while. Tenofovir has been shown in some studies to reduce the risk of acquiring HIV, and in some studies there was also a reduction in the frequency of HSV-2 acquisition, but this is the first time that it is being tested as a drug specifically for HSV-2.



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