Safety and immunogenicity of glycoprotein D-adjuvant genital herpes vaccine.
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.
Bernstein
David I
DI
Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, USA. david.bernstein@cchmc.org
Aoki
Fred Y
FY
Tyring
Stephen K
SK
Stanberry
Lawrence R
LR
St-Pierre
Claude
C
Shafran
Stephen D
SD
Leroux-Roels
Geert
G
Van Herck
Koen
K
Bollaerts
Anne
A
Dubin
Gary
G
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*
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D022301:Herpes Simplex Virus Vaccines; D014759:Viral Envelope Proteins