Principal investigator Dr. Lesia K. Dropulic of the National Institute of Allergy and Infectious Disease's Laboratory of Infectious Diseases said the trial will test an investigational herpes simplex virus type 2 vaccine candidate, called HSV529, for safety and the ability to generate an immune system response. The Phase I trial is being conducted at the National Institute of Health's Clinical Center in Bethesda, Md.
The investigational vaccine was manufactured by Sanofi Pasteur and developed by David Knipe, a professor of microbiology and immunobiology at Harvard Medical School in Boston. Preclinical testing of the candidate vaccine involved a 10-year collaborative effort between Knipe Dr. Jeffrey Cohen, chief of NIAID's Laboratory of Infectious Diseases.
Genital herpes is one of the most common sexually transmitted infections in the United States and while genital herpes is caused by herpes simplex virus type 2, herpes simplex virus type 1 can also cause 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," Dr. Anthony S. Fauci, director of the NIAID, said in a statement.
"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."
An estimated 776,000 people in the United States are infected with herpes simplex virus type 2 or herpes simplex virus type 1 each year.
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