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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. Herpes is a viral disease that causes painful blisters on the genitals and the surrounding areas.
Scientists, according to Science News, have created the vaccine by attacking a viral surface protein called glycoprotein D (gD-2), The herpes virus uses this protein to enter host cells. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced the launch of phase 1 clinical trials into an investigational genital herpes vaccine, according to an agency press release Friday.
Currently, there is no preventive vaccine for genital herpes, Approximately three-quarters of a million people are infected with herpes simplex virus type 2 (HSV-2) and herpes simplex virus type 1 (HSV-1) annually. The investigational vaccine candidate, called HSV529, will be tested in the trials for safety and the its ability to illicit an immune response. The clinical trial is expected to enroll 60 adults ages 18 to 40, who will be divided into three groups of 20 participants each. Within each of the three groups, researchers will randomly assign participants to receive three doses (0.5 milliliters each) of the investigational HSV529 vaccine (15 participants) or a saline-based placebo vaccine (five participants). Early in 2012, Glaxo SmithKline pulled the plug on the trials on their vaccine, Simplirix, after it failed clinical trials. HSV-2 is generally transmitted through sexual contact and can spread even when the infected individual shows no symptoms. Justin Caba Justin Caba is a reporter for Medical Daily focusing on nutrition, fitness, and all things athletic. 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. By deleting gD-2 from the viral genome, researchers have rendered the virus unable to infect cells. The three vaccinations will occur at study enrollment and again one month and six months later. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources.
Sex frequency in relationships can influence overall feelings about a partner and the relationship. All rights reserved.Medical Daily is for informational purposes and should not be considered medical advice, diagnosis or treatment recommendation. 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 addition, the vaccine triggers the body’s own immune cells to produce antibodies that recognize different viral targets.
The investigational vaccine is being tested among study participants who have previously been infected with HSV to determine if it may pose any safety issues. Participant safety will be monitored throughout the course of the trial, and researchers will follow participants for six months after they have received their last dose of vaccine.


Once in the body, HSV migrates to nerve cells and remains there permanently, where it can reactivate to cause painful sores and blisters. 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. Blood samples will be used to evaluate the candidate vaccine’s ability to stimulate immune system responses to HSV-2, including production of virus-specific antibodies and T-cell responses.
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People with a compromised immune system are especially at risk for developing genital herpes.Researchers working on this genital herpes vaccine recruited 156 patients who had tested positive for HSV 2. Throughout the study each participant was asked to record instances of genital herpes signs and symptoms. Although the use of latex condoms can reduce a person’s chance of being infected by HSV 2, signs and symptoms can still occur in the area of the body covered by the condom.




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