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Posted by / 01-Aug-2017 20:17

WH: Numerous publications from the Halford Lab between 20 highlight that a live-attenuated HSV-2 vaccine, the active ingredient in the Theravax vaccine, is 50 to 100 times more effective than the GEN-003 subunit vaccine.Three decades of publications document the repeated failure of HSV-2 glycoprotein D-based subunit vaccines, which is the primary active ingredient in the GEN-003 vaccine.If so, will you be measuring shedding by viral titer, a decrease in transmission during times of asymptomatic shedding, or both?WH: I absolutely want to run many more trials of RVx’s vaccines to address this and many other questions about the efficacy of this live-attenuated HSV-2 vaccine.Can you comment on the difference between Theravax HSV-2 vaccine and prophylactic Valtrex in this regard? Valtrex has limited use in reducing shedding; by most accounts about a 2-fold reduction in shedding.We expect that, given the reductions in symptoms participants are reporting, that the live Theravax HSV-2 vaccine would reduce shedding by 10 to 100-fold, but until we make those measurements, that is little more than speculation.JB: The data (number of outbreaks) from the people who received the vaccination were self-reported, a notoriously unreliable method for data collection.In other words, the possibility for the blurring of real and placebo effects becomes a problem.

Human clinical trials for the live Profavax vaccine, RVx’s preventative vaccine, will take longer to complete; perhaps 2-3 years.JB: Will the upcoming data include more participants, more data on the first 20 participants, or both?WH: The further data we plan to make public over the next 12 months will come from the n=20 people who were enrolled in the 2016 Phase I clinical trial conducted in St Kitts.Still no data or peer review of their claims, but this morning, RVx issued a press release about a Phase I safety study of the company's Theravax (therapeutic) vaccine.JB: Phase I trials are usually conducted for safety only.

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However, the focus for the moment is more about reducing herpes patients’ symptoms than dotting all of the i’s and t’s necessary to offer a formal scientific explanation as to why the therapeutic HSV-2 vaccine works, and measuring the magnitude of the effect.

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