THE EFFICACY AND SAFETY OF SKINNER HERPES-SIMPLEX VACCINE TOWARDS MODULATION OF HERPES GENITALIS - REPORT OF A PROSPECTIVE DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

A randomised, placebo-controlled, multi-centre trial of intracellular subunit herpes simplex virus (HSV) type 1 vaccine NFU.Ac.HSV-1(S-)MRC (Skinner vaccine) was conducted at three medical centres in the United States. Subjects with documented herpes genitalis of at least 1-year duration and a history of six or more genital HSV recurrences in the 1 2 months prior to study entry were randomised to receive vaccine or pl acebo at 0, 1 and 2 months. Vaccination induced significant neutralisi ng, enzyme-linked immunosorbent assay and lymphocyte transformation re sponse to HSV-1 antigen. The frequency of recurrences was reduced in t he vaccinated female patients at both 3 and 6 months following vaccina tion with an overall reduction in patients of both sexes which did not reach statistical significance. Recurrence severity was reduced as me asured by decreased number of lesions and associated symptoms per recu rrence (P = 0.04). The data suggest that clinical manifestations of la tent HSV genital infection may be modified by therapeutic immunisation .