Just three injections appeared to have lasting effects.
Yesterday (June 20), researchers at Indiana University presented their findings about a novel genital herpes treatment at the 2016 ASM Microbe research meeting in Boston.
Based on the results of a phase II clinical trial, the researchers believe that the immunotherapy, called GEN-003, may effectively reduce the activity of the herpes virus as well as the number of days with recurrent herpes.
"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," Dr. Kenneth Fife, an investigator and Professor of Medicine at Indiana University, said in a press release.
GEN-003 is also designed to stimulate antibodies to help neutralize the herpes virus. The treatment is given in a series of three injections, and according to the presented research, it appears to last for up to at least one year.
In the trial, 310 participants who had a history of chronic, recurrent genital herpes were recruited. They received three shots 21 days apart, and the injections were one of six different vaccine doses.
Over the next year, the participants were tested for “viral shedding,” which is the frequency that the herpes virus was detectable on the skin around the genital area, as well as the number of days that lesions from herpes outbreaks were visible. The researchers also tested for stimulation of the immune system against the virus.
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According to the press release on the presented findings, the GEN-003 treatment “drove significant reductions in the rate of viral shedding and lesion frequency compared to rates before treatment.”
An interim report on 6-month data, published by Genocea Biosciences, who funded the study, showed that GEN-003 was associated with more than a 50 percent reduction in viral shedding and up to a 69 percent reduction in genital lesions when compared to baseline observations from before the treatments began.
However, the data tells a slightly different story when you look at the placebo group. Volunteers taking a placebo were monitored for just 28 days after the third and final dose, and at the end of this period, their lesions rates had declined significantly even though they didn’t receive GEN-003. The placebo group did not experience a significant change in viral shedding.
"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.
The current options for herpes treatments aren’t ideal. There are antiviral medications, which have to be taken daily to reduce the number of outbreaks and the risk of transmitting the virus to sexual partners, or they can be taken episodically to treat acute outbreaks after they’ve already occurred.
He says that GEN-003 could potentially provide relief similar to the daily antiviral medications, but without the hassle of having to take medication every day. Further, he says GEN-003 is expected to be tested in combination with antiviral medications, which could theoretically “provide a level of relief not currently achievable.”
"While several previous preventative vaccines have failed in the past, the new approach taken with GEN-003, arming the T cell immune system, may one day lead to an effective prophylactic herpes vaccine," Dr. Fife concluded.
The immune response data are now being analyzed and will be presented at a future conference.
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Editor’s note (June 23): The original article compared the placebo group with the data collected 6 months after the last dose. However, data for the placebo group was only collected once, 28 days after the initial 3 doses, so observations of the treatment group at 6 months can only be compared to baseline observations.
