Journal article
Efficacy Results of a Trial of a Herpes Simplex Vaccine
The New England journal of medicine, Vol.366(1), pp.34-43
2012
DOI: 10.1056/NEJMoa1103151
PMCID: PMC3287348
PMID: 22216840
Abstract
BACKGROUND
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.
METHODS
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.
RESULTS
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).
CONCLUSIONS
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
Details
- Title: Subtitle
- Efficacy Results of a Trial of a Herpes Simplex Vaccine
- Creators
- Robert B BELSHE - Division of Infectious Diseases, Allergy, and Immunology, Saint Louis University, St. Louis, United StatesPeter A LEONE - Department of Epidemiology, University of North Carolina, Chapel Hill, United StatesGary DUBIN - GlaxoSmithKline, King of Prussia, PA, United StatesThomas C HEINEMAN - GlaxoSmithKline, King of Prussia, PA, United StatesJoann M SCHULTE - National Institute of Allergy and Infectious Diseases, Bethesda Maryland, United StatesCarolyn D DEAL - National Institute of Allergy and Infectious Diseases, Bethesda Maryland, United StatesDavid I BERNSTEIN - Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, United StatesAnna WALD - Department of Medicine, Epidemiology, and Laboratory Medicine, Fred Hutchinson Cancer Research Center, Vaccine and Infectious Diseases Division, UniversityofWashington, Seattle, United StatesMyron J LEVIN - Anschutz Medical Campus, Section of Pediatric Infectious Diseases, University of Colorado Denver, Aurora, United StatesJack T STAPLETON - Department of Internal Medicine, University of Iowa, and the Veterans Affairs Medical Center, Iowa City, United StatesIris GORFINKEL - PrimeHealth Clinical Research Organization, Toronto, CanadaRhoda L ASHLEY MORROW - Children's Hospital Virology, Department of Laboratory Medicine, UniversityofWashington, Seattle, United StatesMarian G EWELL - EMMES Corporation, Rockville, United StatesAbbie STOKES-RINER - EMMES Corporation, Rockville, United StatesHerpevac Trial Women
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.366(1), pp.34-43
- Publisher
- Massachusetts Medical Society
- DOI
- 10.1056/NEJMoa1103151
- PMID
- 22216840
- PMCID
- PMC3287348
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Language
- English
- Date published
- 2012
- Academic Unit
- Microbiology and Immunology; Infectious Diseases; Internal Medicine
- Record Identifier
- 9984094612402771
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