Double-blind, placebo-controlled trial of a herpes simplex virus type 2 glycoprotein vaccine in persons at high risk for genital herpes infection

J Infect Dis. 1990 Apr;161(4):653-60. doi: 10.1093/infdis/161.4.653.


To determine the efficacy of a herpes simplex virus type 2 (HSV-2) glycoprotein subunit vaccine, vaccine (50 micrograms) or placebo was administered intramuscularly at weeks 0, 4, and 22 to 161 persons who lacked HSV-2 antibodies and were sex partners of persons with recurrent genital herpes. The annual rate of acquisition of HSV infection was similar among vaccine and placebo recipients (10.7% and 8%, respectively) but was higher in initially seronegative subjects (15.5%) than in those with HSV-1 at entry (5.9%). Eleven (79%) of the 14 HSV infections acquired during follow-up were symptomatic. Vaccination elicited ELISA antibody titers to glycoproteins gD2 and gB2 that were only 10% and 5%, respectively, of titers found in persons with recurrent genital HSV-2 infection. This vaccine failed to provide protection from acquisition of genital HSV infection. The lack of efficacy appears to be related, in part, to the poor immunogenicity of the vaccine.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Antibodies, Viral / biosynthesis
  • Clinical Trials as Topic
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Herpes Genitalis / prevention & control*
  • Herpes Simplex / immunology*
  • Humans
  • Immunoassay
  • Male
  • Prospective Studies
  • Recurrence
  • Risk Factors
  • Sexual Partners
  • Viral Envelope Proteins / immunology
  • Viral Vaccines* / immunology


  • Antibodies, Viral
  • Viral Envelope Proteins
  • Viral Vaccines
  • glycoprotein B, herpes simplex virus type 2
  • glycoprotein D-herpes simplex virus type 2