Safety and immunogenicity of glycoprotein D-adjuvant genital herpes vaccine

被引:56
|
作者
Bernstein, DI
Aoki, FY
Tyring, SK
Stanberry, LR
St Pierre, C
Shafran, SD
Leroux-Roels, G
Van Herck, K
Bollaerts, A
Dubin, G
机构
[1] Cincinnati Childrens Hosp, Med Ctr, Div Infect Dis, Cincinnati, OH 45229 USA
[2] Univ Cincinnati, Cincinnati, OH 45221 USA
[3] Univ Texas, Hlth Sci Ctr, Houston, TX USA
[4] Univ Texas, Med Branch, Galveston, TX 77550 USA
[5] Univ Manitoba, Winnipeg, MB, Canada
[6] Novabyss, Sherbrooke, PQ, Canada
[7] Univ Alberta, Edmonton, AB, Canada
[8] Rijks Univ Gent, Ghent, Belgium
[9] Univ Antwerp, B-2020 Antwerp, Belgium
[10] GlaxoSmithKline Biol, Rixensart, Belgium
关键词
D O I
10.1086/429240
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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. Conclusion. The vaccine was generally safe, well tolerated, and immunogenic.
引用
收藏
页码:1271 / 1281
页数:11
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