The results of a large-scale double-blind, randomized field trial of a glycoprotein D (gD)-based vaccine against herpes simplex virus type 2 (HSV-2) have been reported in the New England Journal of Medicine and, to the surprise of many in the field, have proved disappointing. Previous efficacy trials had shown that, in HSV-discordant couples, the vaccine conferred >70% protection against HSV-2-mediated genital disease in HSV-seronegative women. The current trial recruited 8,323 HSV-seronegative women between 18 and 30 years of age, who were given three doses of either the test vaccine, comprising 20 μg of HSV-2 gD combined with an alum and monophosphorylated lipid A adjuvant, or a control, which was an inactivated hepatitis A virus vaccine. Although the vaccine provided 58% protection against HSV-1-mediated genital disease and 35% protection against HSV-1 infection, only 20% of participants were protected against HSV-2-mediated disease, the primary end point of the trial, and there was no protection against HSV-2 infection. The authors concluded that the failure of this study compared with previous studies could be due to differences in the study populations.
ORIGINAL RESEARCH PAPER
Belshe, R. B. et al. Efficacy results of a trial of a herpes simplex vaccine. N. Engl. J. Med. 366, 34–43 (2012)Article
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Molloy, S. Back to the HSV drawing board. Nat Rev Microbiol 10, 82 (2012). https://doi.org/10.1038/nrmicro2744
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DOI: https://doi.org/10.1038/nrmicro2744