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Glycoprotein-D-adjuvant vaccine to prevent genital herpes

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Please use this identifier to cite or link to this item: http://hdl.handle.net/1928/2376

Glycoprotein-D-adjuvant vaccine to prevent genital herpes

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dc.contributor.author Stanberry, LR
dc.contributor.author Spruance, SL
dc.contributor.author Cunningham, AL
dc.contributor.author Bernstein, DI
dc.contributor.author Mindel, A
dc.contributor.author Sacks, S
dc.contributor.author Tyring, S
dc.contributor.author Aoki, FY
dc.contributor.author Slaoui, M
dc.contributor.author Denis, M
dc.contributor.author Vandepapeliere, P
dc.contributor.author Dubin, G
dc.contributor.author GlaxoSmithKline Herpes Vaccine Efficacy Study Group
dc.date.accessioned 2006-10-30T16:53:39Z
dc.date.available 2006-10-30T16:53:39Z
dc.date.issued 2002-11-21
dc.identifier.citation N Engl J Med. 2002 Nov 21;347(21):1652-61 en_US
dc.identifier.issn 0028-4793
dc.identifier.uri http://hdl.handle.net/1928/2376
dc.description PubMed ID: 12444179 en
dc.description.abstract BACKGROUND: An effective prophylactic vaccine would help control the spread of genital herpes. METHODS: We conducted two double-blind, randomized trials of a herpes simplex virus type 2 (HSV-2) glycoprotein-D-subunit vaccine with alum and 3-O-deacylated-monophosphoryl lipid A in subjects whose regular sexual partners had a history of genital herpes. In Study 1, subjects were seronegative for herpes simplex virus type 1 (HSV-1) and HSV-2; in Study 2, subjects were of any HSV serologic status. At months 0, 1, and 6, subjects received either vaccine or a control injection and were evaluated for 19 months. The primary end point was the occurrence of genital herpes disease in all subjects in Study 1 and in HSV-2-seronegative female subjects in Study 2. RESULTS: A total of 847 subjects who were seronegative for both HSV-1 and HSV-2 (268 of them women, in Study 1) and 1867 subjects who were seronegative for HSV-2 (710 of them women, in Study 2) underwent randomization and received injections. Vaccination was well tolerated and elicited humoral and cellular responses. Overall, the efficacy of the vaccine was 38 percent in Study 1 (95 percent confidence interval, -18 to 68 percent; 15 cases occurred in the vaccine group and 24 in the control group), and efficacy in female subjects was 42 percent in Study 2 (95 percent confidence interval, -31 to 74 percent; 9 cases occurred in the vaccine group and 16 in the control group). In both studies, further analysis showed that the vaccine was efficacious in women who were seronegative for both HSV-1 and HSV-2: efficacy in Study 1 was 73 percent (95 percent confidence interval, 19 to 91 percent; P=0.01), and efficacy in Study 2 was 74 percent (95 percent confidence interval, 9 to 93 percent; P=0.02). It was not efficacious in women who were seropositive for HSV-1 and seronegative for HSV-2 at base line or in men. CONCLUSIONS: These studies suggest that the glycoprotein D vaccine has efficacy against genital herpes in women who are seronegative for both HSV-1 and HSV-2 at base line but not in those who are seropositive for HSV-1 and seronegative for HSV-2. It had no efficacy in men, regardless of their HSV serologic status. en_US
dc.format.extent 127429 bytes
dc.format.mimetype application/pdf
dc.language.iso en_US en_US
dc.publisher Massachusetts Medical Society; Stanberry, LR en_US
dc.relation.ispartofseries 347 en
dc.relation.ispartofseries 21 en
dc.subject rophylactic vaccine en_US
dc.subject genital herpes en_US
dc.subject herpes simplex virus type 2 en_US
dc.title Glycoprotein-D-adjuvant vaccine to prevent genital herpes en_US
dc.type Article en_US


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