HerpeVac Trial for Young Women
Condition: Herpes Simplex Infection
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes
      disease in women who are not infected. The study will enroll approximately 7550 healthy
      women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine
      (experimental group) or hepatitis A vaccine (control group). Participants will receive their
      assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and
      additional unscheduled visits for an evaluation of herpes if it is suspected. Participants
      will be involved in study related procedures for up to 20 months.
    

Detailed description: 
      This study is a double-blind, randomized, controlled Phase III trial to assess the
      prophylactic efficacy and safety of gD-Alum/MPL vaccine in the prevention of genital herpes
      disease in young women who are herpes simplex virus (HSV)-1 and -2 seronegative. The primary
      efficacy objective is to evaluate vaccine efficacy in the prevention of genital herpes
      disease caused by HSV-1 and/or HSV-2 between months 2 and 20 in healthy adult women who were
      initially HSV-1 and HSV-2 seronegative. The secondary efficacy objectives are to: evaluate
      vaccine efficacy in the prevention of genital herpes disease caused by HSV-1 and/or HSV-2
      occurring between the months 7 and 20; evaluate vaccine efficacy in the prevention of HSV-2
      infection between months 2 and 20; and to evaluate vaccine efficacy in the prevention of
      HSV-2 infection occurring between months 7 and 20. The study will enroll approximately 7,550
      women, ages 18-30 years. Participants will be randomized to 1 of 2 possible study groups:
      candidate vaccine; or control vaccine (hepatitis A vaccine). The study duration for each
      subject will be approximately 20 months. Study procedures will include 9 scheduled study
      visits (including the screening visit) and additional unscheduled visits for evaluation of
      suspected herpes disease episodes. Three doses of vaccine or control will be administered
      intramuscularly in the non-dominant deltoid on a 0, 1, and 6 month schedule. Subjects will
      attend clinic visits at screening, months 2, 7, 12, 16, and 20. In subjects who present with
      suspected herpes disease between months 17 and 20, an additional visit to collect a serum
      sample will be scheduled 3 months after the evaluation for suspected genital herpes.
    

Intervention name(s): HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine; Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine
Intervention type(s): Biological; Biological
Intervention description(s): the vaccine was administered intramuscularly in the non-dominant deltoid; the vaccine was administered intramuscularly in the non-dominant deltoid
Intervention MeSH terms: polysaccharide-K; Vaccines; Monophosphoryl lipid A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention