A randomized, double blind, placebo-controlled, parallel group, pilot study to assess the safety and efficacy of a therapeutic Herpes Simplex Virus-2 (HSV-2) Deoxyribonucleic Acid (DNA) vaccine in HSV-2 positive adults

INTERVENTION: HSV‐2 DNA Vaccine 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 CONDITION: Genital Herpes PRIMARY OUTCOME: Safety. Possible adverse events include erythema, induration and pain at the injection site SECONDARY OUTCOME: Immunogenicity. Immune responses to HSV gD2 antigens will be measured using ELISA and ELISPOT assays INCLUSION CRITERIA: Genital HSV‐2 seropositive and genital HSV‐1 seronegative Generally healthy No birthmarks, tattoos, wounds or skin conditions on either forearm