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Sita Awasthi, Harvey M. Friedman, A Paradigm Shift: Vaccine-Induced Antibodies as an Immune Correlate of Protection Against Herpes Simplex Virus Type 1 Genital Herpes, The Journal of Infectious Diseases, Volume 209, Issue 6, 15 March 2014, Pages 813–815, https://doi.org/10.1093/infdis/jit658
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(See the major article by Belshe et al on pages 828–36.)
More than a half-billion people worldwide are infected with genital herpes [1]. During primary infection, herpes simplex virus (HSV) establishes latency in lumbosacral dorsal root ganglia. The natural history of genital herpes is characterized by frequent episodes of recurrences that may be symptomatic or asymptomatic and that transmit virus to sexual partners or from mother to infant during labor and delivery [2–4]. Genital herpes increases the risk of human immunodeficiency virus (HIV) acquisition and transmission by 3- to 4-fold, which underscores the importance of a vaccine to prevent genital herpes [5].
The Herpevac Trial for Women was a large, multicenter, randomized controlled trial of HSV-2 glycoprotein D (gD2) subunit antigen vaccine administered with monophosphoryl lipid A and alum to HSV-1 and HSV-2 doubly seronegative women [6].The primary end point was prevention of genital herpes disease caused by HSV-1 and HSV-2 between months 2 (1 month after the second of 3 doses) and 20. Disease was defined as clinically compatible signs and symptoms confirmed by viral culture, seroconversion, or both. That end point was not achieved.
