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

Abstract

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.

Antibody Responses and Protection in Mice Immunized with Herpes Simplex Virus Type 1 Antigen Immune-stimulating Complex Preparations

“…Although treatment with acyloguanosine (acyclovir) can ameliorate recurrent infection (van Landingham et al, 1988), eradication of an established latent infection using this drug has not been successful (Klein, 1982). Although existing experimental HSV vaccines are also ineffective in eliminating latent virus in both animals and man, subunit vaccines composed of HSV glycoproteins can protect against both primary and spontaneous recurrences in guineapigs (Stanberry et al, 1987) and may provide protection against the acquisition of herpes genitalis in man (Skinner et al, 1987). It remains possible that such vaccines administered to susceptible individuals before contact with HSV, may prevent clinical illness and perhaps also modify the establishment of latent infection.…”

Herpes Simplex Virus and Human Cytomegalovirus: Their Role in Morphological Transformation and Genital Cancers

“…Although the treatment (three times weekly for 80 to 100 weeks) appears traumatic the lack of dysplasia or carcinomas in mice similarly treated with control DNAs suggests some specific role for HSV-2 DNA. Similar types of investigation (Chen et al, 1986) have been carried out in China in conjunction with the Skinner vaccine (for reference, see Skinner et al, 1987). Skinner's group has produced a subunit vaccine against HSV-2 and Chen has used it to protect mice against the development of cervical carcinoma after the application of HSV-2 to the cervix.…”

Herpes immunization—on the threshold

“…Investigators began examining the efficacy of experimental vaccines in preventing primary genital herpes. In their second study they further evaluated the effectiveness of the HSV-1 subunit vaccine in 50 subjects [21]. These difficulties are exemplified by the early studies by Skinner and colleagues.…”