Efficacy Results of a Trial of a Herpes Simplex Vaccine

• Published in: The New England journal of medicine Vol. 366; no. 1; pp. 34 - 43
• Main Authors: Belshe, Robert B, Leone, Peter A, Bernstein, David I, Wald, Anna, Levin, Myron J, Stapleton, Jack T, Gorfinkel, Iris, Morrow, Rhoda L. Ashley, Ewell, Marian G, Stokes-Riner, Abbie, Dubin, Gary, Heineman, Thomas C, Schulte, Joann M, Deal, Carolyn D
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 05.01.2012
• Subjects: Adolescent; Adult; Allergies; Aluminum sulfate; Antibodies; Biological and medical sciences; Double-Blind Method; Enzyme-linked immunosorbent assay; Female; General aspects; Genital diseases; Genitalia, Female - virology; Glycoprotein D; Hepatitis; Hepatitis A; Herpes Genitalis - prevention & control; Herpes Genitalis - virology; Herpes simplex; Herpes Simplex Virus Vaccines - adverse effects; Herpes Simplex Virus Vaccines - immunology; Herpesvirus 1, Human; Herpesvirus 2, Human; Human viral diseases; Humans; Infections; Infectious diseases; Lipid A; Male; Medical sciences; Monophosphoryl lipid A; Population studies; Prevention and actions; Public health. Hygiene; Public health. Hygiene-occupational medicine; Risk Factors; Treatment Outcome; Vaccine efficacy; Vaccines; Viral diseases; Viral diseases with cutaneous or mucosal lesions and viral diseases of the eye; Viral Envelope Proteins; Virus Shedding; Womens health; Young Adult; Canada; United States > US; Infection; Medicine; Prevention; Immunoprophylaxis; Trial; Viral disease; Treatment efficiency; Herpes; Clinical trial; Vaccine; Result
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa1103151

There is no vaccine to prevent herpes simplex virus (HSV) infection. In this trial in 8323 women, a candidate HSV vaccine containing glycoprotein D was found to be ineffective in preventing HSV-2 infection. Both herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) can cause primary infection of the genital tract, and HSV-1 infection has become an increasingly frequent cause of genital disease. 1 The majority of HSV infections are asymptomatic, and only 10 to 25% of persons with HSV-2 antibodies have recurrent genital disease. 2 , 3 Transmission of HSV from infected women to neonates may lead to severe neurologic disease or death in the newborn. Strategies to control genital herpes infection and disease have mainly focused on antiviral chemotherapy, education, and the use of condoms. The availability of an effective prophylactic vaccine would . . .