PLACEBO-CONTROLLED TRIAL OF VACCINATION WITH RECOMBINANT GLYCOPROTEIN-D OF HERPES-SIMPLEX VIRUS TYPE-2 FOR IMMUNOTHERAPY OF GENITAL HERPES LANCET Straus, S. E., Corey, L., BURKE, R. L., SAVARESE, B., Barnum, G., Krause, P. R., KOST, R. G., Meier, J. L., Sekulovich, R., ADAIR, S. F., Dekker, C. L. 1994; 343 (8911): 1460-1463

Abstract

Immunotherapy of chronic viral diseases with vaccines is an important but unproven concept. We investigated the effect of a vaccine containing recombinant glycoprotein D (gD2) of herpes simplex virus type 2 (HSV-2) on the frequency of symptomatic outbreaks in patients with genital herpes. 98 patients with documented genital herpes who reported 4-14 recurrences per year were enrolled in a double-blind, placebo-controlled trial. Subjects received injections of either 100 micrograms gD2 in alum or alum alone (placebo) at 0 and 2 months, and recurrences were documented for 1 year. The vaccine was well tolerated. gD2 recipients reported fewer recurrences per month than placebo recipients (mean 0.42 [SE 0.05] vs 0.55 [0.05]; p = 0.055), had fewer virologically confirmed recurrences per month (0.18 [0.03] vs 0.28 [0.03]; p = 0.019), and had a lower median number of recurrences for the study year (4 [range 0-17] vs 6 [0-15]; p = 0.039). Neither genital recurrence nor the placebo vaccine had any discernible effect on HSV-2-specific antibody responses, but gD2 vaccine boosted neutralising antibodies to HSV-2 fourfold and gD2-specific titres sevenfold over baseline levels. These results inspire optimism about the potential use of vaccine for the treatment of chronic, recurring viral diseases.

View details for Web of Science ID A1994NQ41500008

View details for PubMedID 7911177