title: Correlate of immune protection against HSV-1 genital disease in vaccinated women.
abstract: BACKGROUND
  Previously we conducted a double-blind controlled, randomized efficacy field trial of gD-2 HSV vaccine adjuvanted with ASO4 in 8323 women. Subjects had been previously selected to be seronegative for HSV-1 and HSV-2. We found that vaccine was 82% protective against HSV-1 genital disease, but offered no significant protection against HSV-2 genital disease.
  
  
  METHODS
  To better understand the results of the efficacy study, post-vaccination anti-gD-2 antibody concentrations from all HSV infected subjects and matched uninfected controls were measured. Three models were used to determine whether thes responses correlated with protection against HSV infection or disease. Similarly, cellular immune responses from a subset of subjects and matched controls were evaluated for a correlation with HSV protection.
  
  
  RESULTS
  Antibodies to gD-2 correlated with protection against HSV-1 infection with higher antibody concentration associated with higher efficacy. Cellular immune responses to gD-2 did not correlate with protection.
  
  
  CONCLUSIONS
  The protection against HSV-1 infection observed in the Herpevac Trial for Women was associated with antibodies directed against the vaccine. Clinical Trials Registration NCT00057330.
authors.affiliation: Department of Internal Medicine, Division of Infectious Diseases, Allergy & Immunology, Saint Louis University School of Medicine, St. Louis, Missouri 63104, USA.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Belshe
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Heineman
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: Abbie R
authors.initials: AR
authors.lastname: Bellamy
authors.forename: Marian
authors.initials: M
authors.lastname: Ewell
authors.forename: Robbert
authors.initials: R
authors.lastname: van der Most
authors.forename: Carolyn D
authors.initials: CD
authors.lastname: Deal
mesh_terms: D000914:Antibodies, Viral / Q000096:biosynthesis / Q000097:blood / Q000276:immunology; D016022:Case-Control Studies; D016207:Cytokines / Q000097:blood; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006558:Herpes Genitalis / Q000097:blood / Q000276:immunology* / Q000517:prevention & control*; D022301:Herpes Simplex Virus Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D018259:Herpesvirus 1, Human / Q000276:immunology*; D006801:Humans; D011446:Prospective Studies
chemical_list: D000914:Antibodies, Viral; D016207:Cytokines; D022301:Herpes Simplex Virus Vaccines
keywords: HSV vaccine; protective antibodies; vaccine efficacy