title: Safety and immunogenicity of glycoprotein D-adjuvant genital herpes vaccine.
abstract: BACKGROUND
  Two previous trials have suggested that a herpes simplex virus (HSV) type 2 glycoprotein D (gD) vaccine combined with the adjuvants alum and 3'-O-deacylated-monophosphoryl lipid A (MPL) is well tolerated and provides protection against genital herpes disease in women with no preexisting HSV antibody.
  
  
  METHODS
  The safety and immunogenicity of this vaccine were evaluated in a large, multicenter, double-blind, randomized, placebo-controlled trial. The effects of sex and preexisting HSV immunity were sought.
  
  
  RESULTS
  When solicited symptoms that continued after the initial 4 days of observation were excluded, the incidence of unsolicited symptoms occurring during the 7 months after vaccination (the primary analysis period) was 22.1% in vaccine recipients and 21.9% in placebo recipients. Significant increases in the number of local and systemic symptoms were found in vaccine recipients within 4 days after vaccination. However, most symptoms were mild to moderate in severity and were short lived. Women reported symptoms more frequently than did men, but preexisting immunity had little effect. The vaccine induced higher titers of HSV gD antibody on enzyme-linked immunosorbent assays than did natural infection with HSV.
  
  
  CONCLUSIONS
  The vaccine was generally safe, well tolerated, and immunogenic.
authors.affiliation: Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, USA. david.bernstein@cchmc.org
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: Fred Y
authors.initials: FY
authors.lastname: Aoki
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Tyring
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Stanberry
authors.forename: Claude
authors.initials: C
authors.lastname: St-Pierre
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Shafran
authors.forename: Geert
authors.initials: G
authors.lastname: Leroux-Roels
authors.forename: Koen
authors.initials: K
authors.lastname: Van Herck
authors.forename: Anne
authors.initials: A
authors.lastname: Bollaerts
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects*; D000328:Adult; D000914:Antibodies, Viral / Q000276:immunology; D005260:Female; D006558:Herpes Genitalis / Q000276:immunology* / Q000517:prevention & control*; D022301:Herpes Simplex Virus Vaccines / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014759:Viral Envelope Proteins / Q000276:immunology*
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D022301:Herpes Simplex Virus Vaccines; D014759:Viral Envelope Proteins