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
Background An effective prophylactic vaccine would help controlthe spread of genital herpes.
Methods We conducted two double-blind, randomized trials ofa herpes simplex virus type 2 (HSV-2) glycoprotein-D–subunitvaccine with alum and 3-O-deacylated-monophosphoryl lipid Ain subjects whose regular sexual partners had a history of genitalherpes. In Study 1, subjects were seronegative for herpes simplexvirus type 1 (HSV-1) and HSV-2; in Study 2, subjects were ofany HSV serologic status. At months 0, 1, and 6, subjects receivedeither vaccine or a control injection and were evaluated for19 months. The primary end point was the occurrence of genitalherpes disease in all subjects in Study 1 and in HSV-2–seronegativefemale subjects in Study 2.
Results A total of 847 subjects who were seronegative for bothHSV-1 and HSV-2 (268 of them women, in Study 1) and 1867 subjectswho were seronegative for HSV-2 (710 of them women, in Study2) underwent randomization and received injections. Vaccinationwas well tolerated and elicited humoral and cellular responses.Overall, the efficacy of the vaccine was 38 percent in Study1 (95 percent confidence interval, –18 to 68 percent;15 cases occurred in the vaccine group and 24 in the controlgroup), and efficacy in female subjects was 42 percent in Study2 (95 percent confidence interval, –31 to 74 percent;9 cases occurred in the vaccine group and 16 in the controlgroup). In both studies, further analysis showed that the vaccinewas efficacious in women who were seronegative for both HSV-1and HSV-2: efficacy in Study 1 was 73 percent (95 percent confidenceinterval, 19 to 91 percent; P=0.01), and efficacy in Study 2was 74 percent (95 percent confidence interval, 9 to 93 percent;P=0.02). It was not efficacious in women who were seropositivefor HSV-1 and seronegative for HSV-2 at base line or in men.
Conclusions These studies suggest that the glycoprotein D vaccinehas efficacy against genital herpes in women who are seronegativefor both HSV-1 and HSV-2 at base line but not in those who areseropositive for HSV-1 and seronegative for HSV-2. It had noefficacy 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{at}utmb.edu.
A Human Papillomavirus Type 16 Vaccine
Duggirala M. K., Cuddihy M.-T., Tammela J. E., Lele S., Odunsi K., Schrag S. J., Schuchat A., Schulkin J., Gambacorti C. B., Yoo S. S., Whitmore S. E., Koutsky L. A., Stanberry L. R.
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N Engl J Med 2003;
348:1402-1405, Apr 3, 2003.
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