Double-blind, placebo-controlled trial of a herpes simplex virus type 2 glycoprotein vaccine in persons at high risk for genital herpes infection.
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.
Mertz
G J
GJ
Department of Laboratory Medicine, University of Washington, Seattle.
Ashley
R
R
Burke
R L
RL
Benedetti
J
J
Critchlow
C
C
Jones
C C
CC
Corey
L
L
D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006558:Herpes Genitalis / Q000517:prevention & control*; D006561:Herpes Simplex / Q000276:immunology*; D006801:Humans; D007118:Immunoassay; D008297:Male; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors; D012747:Sexual Partners; D014759:Viral Envelope Proteins / Q000276:immunology; D014765:Viral Vaccines / Q000276:immunology
D000914:Antibodies, Viral; D014759:Viral Envelope Proteins; D014765:Viral Vaccines; C044525:glycoprotein B, herpes simplex virus type 2; C040570:glycoprotein D-herpes simplex virus type 2