Two injection regimens of the HSV-2 DNA vaccine will be compared with placebo, administered by intradermal injection as three, 4-weekly doses followed by a 6-month booster. The first injection regime will consist of subjects receiving an injection to each forearm. Once this is fully allocated, the second injection regime will commence recruiting. The second injection regime consists of two injections into the one forearm. Each injection will contain a dose of 500 mcg
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Antibody responses will be measured prior to vaccination and 4 weeks after each vaccination. Cell mediated responses will be measured at baseline and 1 week after each vaccination and at end of study visit 6 months post final vaccination
Actual date last participant enrolled: 4/02/2016
So there is a 12 month lag to final results for each participant; primary and secondary end-points are 6 months after their 6 month booster.
Also, results from the Phase I trial (in healthy volunteers) reached pre-print recently. Not sure if anyone has already posted;
