IMMUNOTHERAPY OF RECURRENT GENITAL HERPES WITH RECOMBINANT HERPES-SIMPLEX VIRUS TYPE-2 GLYCOPROTEIN-D AND GLYCOPROTEIN-B - RESULTS OF A PLACEBO-CONTROLLED VACCINE TRIAL

To determine the safety, immunogenicity, and efficacy of a recombinant herpes simplex virus type 2 glycoprotein D and B vaccine in the treat ment of recurrent genital herpes, a randomized, placebo-controlled tri al was held at two referral centers. Healthy patients with 4-14 recurr ences per year received injections of both glycoproteins in MF59 adjuv ant or of MF59 alone at 0, 2, 12, and 14 months. For 18 study months, the rate and number of recurrences, the duration and severity of the f irst confirmed recurrence, vaccine immunogenicity, and rates of local and systemic reactions were determined. The monthly rate of recurrence s was not significantly improved, but the duration and severity of the first study outbreak was reduced significantly by vaccination. Glycop rotein-specific and neutralizing antibodies were boosted by vaccinatio n for the duration of the study. This vaccine is safe and immunogenic and ameliorated an observed first postvaccination genital recurrence, but it does not reduce recurrence frequency.