Efficacy Results of a Trial of a Herpes Simplex Vaccine
Top Cited Papers
- 5 January 2012
- journal article
- research article
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 366 (1), 34-43
- https://doi.org/10.1056/nejmoa1103151
Abstract
Two previous studies of a herpes simplex virus type 2 (HSV-2) subunit vaccine containing glycoprotein D in HSV-discordant couples revealed 73% and 74% efficacy against genital disease in women who were negative for both HSV type 1 (HSV-1) and HSV-2 antibodies. Efficacy was not observed in men or HSV-1 seropositive women. We conducted a randomized, double-blind efficacy field trial involving 8323 women 18 to 30 years of age who were negative for antibodies to HSV-1 and HSV-2. At months 0, 1, and 6, some subjects received the investigational vaccine, consisting of 20 μg of glycoprotein D from HSV-2 with alum and 3-O-deacylated monophosphoryl lipid A as an adjuvant; control subjects received the hepatitis A vaccine, at a dose of 720 enzyme-linked immunosorbent assay (ELISA) units. The primary end point was occurrence of genital herpes disease due to either HSV-1 or HSV-2 from month 2 (1 month after dose 2) through month 20. The HSV vaccine was associated with an increased risk of local reactions as compared with the control vaccine, and it elicited ELISA and neutralizing antibodies to HSV-2. Overall, the vaccine was not efficacious; vaccine efficacy was 20% (95% confidence interval [CI], −29 to 50) against genital herpes disease. However, efficacy against HSV-1 genital disease was 58% (95% CI, 12 to 80). Vaccine efficacy against HSV-1 infection (with or without disease) was 35% (95% CI, 13 to 52), but efficacy against HSV-2 infection was not observed (−8%; 95% CI, −59 to 26). In a study population that was representative of the general population of HSV-1– and HSV-2–seronegative women, the investigational vaccine was effective in preventing HSV-1 genital disease and infection but not in preventing HSV-2 disease or infection. (Funded by the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline; ClinicalTrials.gov number, NCT00057330.)Keywords
This publication has 20 references indexed in Scilit:
- Maternal and Neonatal Herpes Simplex Virus InfectionsNew England Journal of Medicine, 2009
- Increasing role of herpes simplex virus type 1 in first-episode anogenital herpes in heterosexual women and younger men who have sex with men, 1992-2006Sexually Transmitted Infections, 2009
- Optimizing PCR Positivity Criterion for Detection of Herpes Simplex Virus DNA on Skin and MucosaJournal of Clinical Microbiology, 2007
- Prevalence of infection with herpes simplex virus types 1 and 2 in Australia: a nationwide population based surveySexually Transmitted Infections, 2006
- Safety and Immunogenicity of Glycoprotein D--Adjuvant Genital Herpes VaccineClinical Infectious Diseases, 2005
- Seroprevalence and Seroincidence of Herpes Simplex Virus Type 1 and Herpes Simplex Virus Type 2 Infections in a Cohort of Adolescents in ItalySexually Transmitted Diseases, 2004
- Increasing Proportion of Herpes Simplex Virus Type 1 as a Cause of Genital Herpes Infection in College StudentsSexually Transmitted Diseases, 2003
- Herpes Simplex Virus Type 1 Is the Prevailing Cause of Genital Herpes in the Tel Aviv Area, IsraelSexually Transmitted Diseases, 2003
- The burden of infection with HSV-1 and HSV-2 in England and Wales: implications for the changing epidemiology of genital herpesSexually Transmitted Infections, 2000
- Reactivation of Genital Herpes Simplex Virus Type 2 Infection in Asymptomatic Seropositive PersonsNew England Journal of Medicine, 2000