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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
UNITED STATES: NIH Launches Trial of Investigational Genital Herpes Vaccine
Staff Writer
November 11, 2013
eNews Park Forest (11.08.2013) Aids Weekly Plus

eNews Park Forest recently reported that the National Institute of Allergy and Infectious Diseases (NIAID) has launched a Phase 1 trial of HSV529, an investigational vaccine for herpes simplex virus type 2 (HSV-2). The trial would test the safety of HSV529 and assess the vaccine’s ability to generate an immune system response. NIH estimated that 776,000 US residents acquired genital herpes each year. HSV-2 caused most genital herpes infections, but herpes simplex virus type 1 (HSV-1) also could cause genital herpes. NIAID Director Anthony S. Fauci, MD, stated that genital herpes was a life-long infection that increased the risk of acquiring HIV. Women who had active genital herpes at the time of birth could transmit the virus to their infants, which could cause “severe illness and death.” David Knipe, PhD, professor of microbiology and immunology at Harvard Medical School, developed the investigational vaccine, manufactured by Sanofi Pasteur. HSV529 was a replication-defective vaccine that removed two key proteins from the virus, preventing it from multiplying. The trial plans to enroll 60 adults ages 18–40, divided into three 20-participant groups. Group 1 would consist of people coinfected with HSV-1 and HSV-2, or only with HSV-2. Group 2 would include only people with HSV-1. Group 3 would include only people never infected. Within each group, researchers randomly would assign 15 participants to receive three 0.5 milliliter doses of HSV529 and five participants to receive a saline-based placebo. Doses would take place at enrollment, one month later, and six months later. Researchers would monitor participants during the trial and for six additional months. The trial would use blood samples to evaluate the vaccine’s ability to stimulate an immune response to HSV-2. Researchers expected to complete the trial by October 2016. Use the identifier NCT01915212 to learn more at http://www.ClinicalTrials.gov.

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