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NIH launches trial of investigational genital herpes vaccine
Date:11/8/2013

vaccine, meaning that scientists have removed two key proteins from the vaccine virus so that it cannot multiply to cause genital herpes.

The clinical trial is expected to enroll 60 adults ages 18 to 40, who will be divided into three groups of 20 participants each. The first group will be of people who have been previously infected with HSV-2 and HSV-1 or solely with HSV-2; the second will have individuals who had been infected with HSV-1 only; and the third will consist of those who have not been infected with HSV-1 or HSV-2. 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.

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). The three vaccinations will occur at study enrollment and again one month and six months later. 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. 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. The study is expected to be completed by October 2016.

HSV-2 is generally transmitted through sexual contact and can spread even when the infected individual shows no symptoms. Although HSV-1 commonly infects the mouth and lips, it can also cause genital herpes. Once in the body, HSV migrates to nerve cells and remains there permanently, where it can reactivate to cause painful sores and blisters.


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Contact: Jennifer Routh
jennifer.routh@nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
Source:Eurekalert

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