title: Immunotherapy of recurrent genital herpes with recombinant herpes simplex virus type 2 glycoproteins D and B: results of a placebo-controlled vaccine trial.
abstract: To determine the safety, immunogenicity, and efficacy of a recombinant herpes simplex virus type 2 glycoprotein D and B vaccine in the treatment of recurrent genital herpes, a randomized, placebo-controlled trial was held at two referral centers. Healthy patients with 4-14 recurrences per year received injections of both glycoproteins in MF59 adjuvant or of MF59 alone at 0, 2, 12, and 14 months. For 18 study months, the rate and number of recurrences, the duration and severity of the first confirmed recurrence, vaccine immunogenicity, and rates of local and systemic reactions were determined. The monthly rate of recurrences was not significantly improved, but the duration and severity of the first study outbreak was reduced significantly by vaccination. Glycoprotein-specific and neutralizing antibodies were boosted by vaccination for the duration of the study. This vaccine is safe and immunogenic and ameliorated an observed first postvaccination genital recurrence, but it does not reduce recurrence frequency.
authors.affiliation: Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892, USA.
authors.forename: S E
authors.initials: SE
authors.lastname: Straus
authors.forename: A
authors.initials: A
authors.lastname: Wald
authors.forename: R G
authors.initials: RG
authors.lastname: Kost
authors.forename: R
authors.initials: R
authors.lastname: McKenzie
authors.forename: A G
authors.initials: AG
authors.lastname: Langenberg
authors.forename: P
authors.initials: P
authors.lastname: Hohman
authors.forename: J
authors.initials: J
authors.lastname: Lekstrom
authors.forename: E
authors.initials: E
authors.lastname: Cox
authors.forename: M
authors.initials: M
authors.lastname: Nakamura
authors.forename: R
authors.initials: R
authors.lastname: Sekulovich
authors.forename: A
authors.initials: A
authors.lastname: Izu
authors.forename: C
authors.initials: C
authors.lastname: Dekker
authors.forename: L
authors.initials: L
authors.lastname: Corey
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006558:Herpes Genitalis / Q000628:therapy*; D018258:Herpesvirus 2, Human / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000276:immunology; D012008:Recurrence; D014614:Vaccines, Synthetic / Q000276:immunology*; D014759:Viral Envelope Proteins / Q000276:immunology*; D014765:Viral Vaccines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000914:Antibodies, Viral; D011994:Recombinant Proteins; D014614:Vaccines, Synthetic; D014759:Viral Envelope Proteins; D014765:Viral Vaccines; C044525:glycoprotein B, herpes simplex virus type 2; C040570:glycoprotein D-herpes simplex virus type 2