BOSTON — A three-injection treatment for genital herpes, an immunotherapy called GEN-003, may reduce the activity of the virus and the number of days with recurrent herpes and appears to last for up to at least one year, according to data presented at the ASM Microbe meeting.

“GEN-003 is believed to work through a different pathway from most vaccines by recruiting T cells, which are critical to controlling chronic infections such as herpes,” Kenneth H. Fife, MD, PhD, an investigator and Professor of Medicine at Indiana University said in a prepared statement about the findings. In addition, GEN-003 is also designed to stimulate antibodies to help neutralize the virus.

Three hundred and ten participants with a history of chronic, recurrent genital herpes received three shots of one of six different vaccine doses, 21 days apart. Over 1 year, participants were tested for stimulation of the immune system against the herpes virus, the frequency that the herpes virus was detectable on the skin around the genital area (“viral shedding”), and the number of days that herpes outbreaks (“lesions”) were visible. GEN-003 treatment drove significant reductions in the rate of viral shedding and lesion frequency compared to rates before treatment. Immune response data are being analyzed and will be the topic of a future presentation.

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“The importance of these clinical findings is that it represents a new approach to treatment, and may provide a new option for patients suffering from chronic, recurrent genital herpes,” said Dr. Fife. Current treatments consist of antiviral medications, which may be taken episodically to treat acute lesion outbreaks, or daily to reduce the number of outbreaks and the risk of transmitting the herpes simplex 2 (HSV-2) virus to sexual contacts.

The study was sponsored by Genocea Biosciences, Cambridge, MA.


Fife KH. Poster session. Presented at: ASM Microbe. 2016. June 16-20, 2016. Boston.