Ineffectiveness and toxicity of BCG vaccine for the prevention of recurrent genital herpes.

One hundred fifty-five patients with genital herpes were enrolled in a double-blind, placebo-controlled trial comparing 0.1 ml of intradermal BCG vaccine with placebo for the prevention of recurrent episodes of genital herpes. The mean rate or recurrence over 9 months of prospective follow-up was 0.528 recurrences per month in BCG recipients compared with 0.392 recurrences per month in placebo recipients (not significant). The BCG vaccine also failed to influence the duration of lesions in the first recurrent episode of genital herpes after vaccination. Six patients were given a second inoculation of BCG vaccine, and persistent cutaneous granulomas were noted in three of these six patients. Intradermal inoculation with BCG does not appear to affect the natural history of genital herpes, and repeated inoculations can be toxic.