Researchers have launched an early-stage clinical trial of an investigational vaccine designed to prevent genital herpes disease. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the Phase I trial, which is being conducted at the NIH Clinical Center in Bethesda, Maryland. Genital herpes is one of the most common sexually transmitted infections in the United States. Most genital herpes cases are caused by infection with herpes simplex virus type 2 (HSV-2); however, herpes simplex virus type 1 (HSV-1) can also cause genital herpes. An estimated 776,000 people in the United States are infected with HSV-2 or HSV-1 each year. There is no vaccine to prevent genital herpes. "Although genital herpes is treatable, it is a lifelong infection that can exact a substantial psychological and physical toll on infected individuals and places them at higher risk of acquiring HIV," said NIAID Director Anthony S. Fauci, M.D. "Furthermore, mothers with active genital herpes infection at time of delivery can transmit the virus to their newborns, which can lead to severe illness and death. A protective vaccine would help to reduce significantly the spread of this all-too- common sexually transmitted infection," Dr. Fauci added. Led by principal investigator Lesia K. Dropulic, M.D., of NIAID's Laboratory of Infectious Diseases, the trial will test an investigational HSV-2 vaccine candidate, called HSV529, for safety and the ability to generate an immune system response. The investigational vaccine, manufactured by Sanofi Pasteur, was developed by David Knipe, Ph.D., professor of microbiology and immunobiology at Harvard Medical School, Boston. Preclinical testing of the candidate vaccine involved a 10-year collaborative effort between Dr.
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