Follow-up report on 50 subjects vaccinated against herpes genitalis with Skinner vaccine.

Fifty subjects at risk of herpes genitalis received 109 immunizations with Skinner herpes vaccine and were assessed after a follow-up period of 4-48 months, representing a total follow-up period of 694 patient months. There was no evidence of contraction of herpes genitalis in 49 subjects. The risk of virus transmission and rate of contraction of disease was quantified by construction of two functions, namely a unit of exposure risk calculated per year (UYE) and standard contraction rate (SCR); in this study the SCR was 0.02. There was no evidence of significant side-effects from vaccination. Administration of Alhydrogel adjuvant with vaccine induced temporary granuloma formation in most subjects but was only detectable beyond 1 year of follow-up in one subject, in whom a painless swelling of 0.2 cm was detected 3 years after vaccination. There was no evidence of immunological reactivity to host cell or calf serum antigens in any of the subjects vaccinated.