Genocea has reviewed early study results from all patients after they completed Study Day 71 (an “interim analysis”). The study is still ongoing, and all participants will be followed until 1 year after their last vaccination.
The interim results show that study participants who received the middle and high doses (30 and 100 µg) of GEN-003 with the adjuvant had less viral shedding 1 month after their last vaccination. By comparison, patients who received placebo, or GEN-003 without adjuvant, did not.
At this time, we do not know which individual patients had a positive result. That information will be known when the study is over. The study was not designed to test if patients had fewer herpes outbreaks after vaccination. That will be tested in later clinical studies.
For patients in the study, this means that you still may have outbreaks and viral shedding, and may be at risk for transmission to your sex partner even if you received the middle or high dose with adjuvant. In addition, we do not know how long an effect, if any, will last. You should continue to practice abstinence or use a condom to reduce the chance of passing the infection to a sexual partner during this clinical trial.