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NIH Launches Trial of Investigational Vaccine for Genital Herpes
Researchers have launched an early-stage clinical trial of an investigational vaccine designed to prevent genital herpes infection. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is sponsoring the phase I trial, which is being conducted at the NIH Clinical Center in Bethesda, Maryland.
The study will test an investigational herpes simplex virus-2 (HSV-2) vaccine candidate, called HSV529, for safety and for the ability to generate an immune response. The investigational vaccine is manufactured by Sanofi Pasteur.
The clinical trial is expected to enroll 60 adults aged 18 to 40 years, who will be divided into three groups of 20 participants each. The first group will consist of participants who have been previously infected with HSV-2 and HSV-1 or only with HSV-2; the second group will have individuals who had been infected only with HSV-1; and the third group will consist of those who have not been infected with HSV-1 or HSV-2.
Within each of the three groups, researchers will randomly assign participants to receive three doses (0.5 mL each) of the HSV529 vaccine (15 participants) or a saline-based placebo vaccine (five participants). The three vaccinations will occur at study enrollment and again 1 month and 6 months later. Researchers will follow the participants for 6 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 responses to HSV-2, including the production of virus-specific antibodies and T-cell responses.
The study is expected to be completed by October 2016.
Source: NIH; November 8, 2013.