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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.
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Recurrence of varicella zoster virus (VZV) is a painful condition that can have long-term sequelae especially in the elderly.
However, cornea specialists may be adding another relative contraindication: those patients with a history of prior herpes zoster ophthalmicus (HZO). The 63-year-old male patient's herpes zoster keratouveitis and neurotrophic keratopathy was quiescent for three and a half years without medication. University of Toronto, after she saw mild recurrences of iritis after vaccination in some patients with a history of herpes zoster ophthalmicus.


Even more concerning was the case of a colleague's patient with a history of treatable recurrent bouts over many years of mild HZV-related keratitis and hypertensive iritis. Ocular inflammation from herpes zoster ophthalmicus can recur or recrudesce on its own even in the absence of the vaccine, he said. Reports of acute retinal necrosis?including isolation of the vaccine strain in one?and exacerbation of zoster interstitial keratitis and keratouveitis after vaccination have led Dr. 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. Post-herpetic neuralgia is a very painful complication and one that can have a serious effect on the quality of life of many individuals. There have been several reports of recurrence of HZO after patients received the herpes zoster vaccine.


Holland, MD, professor of ophthalmology, University of Cincinnati, and director, cornea service, Cincinnati Eye Institute. Liesegang to continue to recommend the zoster vaccine for all patients over age 50 except for those who are immunocompromised or on steroids.  Jay Pepose, MD, director, Pepose Vision Institute, and professor of clinical ophthalmology, Washington University School of Medicine, St. Pepose to elicit histories of any immunosuppressive drugs or immunosuppressive conditions in patients that may contraindicate vaccination. Pepose recommends the zoster vaccine for patients with a history of HZO but he carefully monitors them following vaccination. 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. The herpes zoster vaccine has been recommended for adults 60 years and older, and in some cases 50 years and older, whether or not the patient had a prior episode of VZV. Louis, agreed that it remains unclear whether the recurrence stems from a reactivation of latent varicella-zoster, from the vaccine strain itself or from a boost in immunity.
He also recommends against the zoster vaccine for patients who are allergic to neomycin, gelatin, or other components of the vaccine. 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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