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http://content.nejm.org/cgi/content/short/347/21/1652?query=TOC
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Glycoprotein-D–Adjuvant Vaccine to Prevent Genital Herpes
Lawrence R. Stanberry, M.D., Ph.D., Spotswood L. Spruance, M.D., Anthony L. Cunningham, M.D., David I. Bernstein, M.D., Adrian Mindel, M.D., Stephen Sacks, M.D., Stephen Tyring, M.D., Ph.D., Fred Y. Aoki, M.D., Moncef Slaoui, Ph.D., Martine Denis, Ph.D., Pierre Vandepapeliere, M.D., Gary Dubin, M.D., for the GlaxoSmithKline Herpes Vaccine Efficacy Study Group
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.
Source Information
From the University of Texas Medical Branch, Galveston (L.R.S., S.T.); the University of Utah, Salt Lake City (S.L.S.); the Westmead Millennium Institute (A.L.C.) and the Sexually Transmitted Infections Research Centre (A.M.), Westmead Hospital and University of Sydney, Westmead, Australia; the Cincinnati Children's Hospital Medical Center, Cincinnati (D.I.B.); Viridae Clinical Sciences, Vancouver, B.C., Canada (S.S.); the University of Manitoba, Winnipeg, Canada (F.Y.A.); and GlaxoSmithKline Biologicals, Rixensart, Belgium (M.S., M.D., P.V., G.D.).
Address reprint requests to Dr. Stanberry at the Department of Pediatrics and Sealy Center for Vaccine Development, University of Texas Medical Branch, 3.300 Children's Hospital, 301 University Blvd., Galveston, TX 77555-0351, or at l.stanberry@utmb.edu.
This article has been cited by other articles:
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