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Infection with herpes simplex virus type 2 (HSV-2) can be transmitted via asymptomatic viral shedding and produce recurrent genital lesions. Current management includes episodic or continuous antiviral therapy, such as with valacyclovir. However, such therapy is only partially effective.
To improve on these results, investigators with industry sponsorship tested a purified protein subunit vaccine that contained two fragments of HSV-2 (GEN-003) and a novel adjuvant. Patients with recurrent HSV-2 outbreaks received three doses of GEN-003 at one of three concentrations (10 µg, 30 µg, or 100 µg), with or without the adjuvant, or placebo. Patients collected genital swab samples to measure shedding and performed daily lesion counts.
Local and syste…