HerpeVac Trial for Young Women
Condition: Herpes Simplex Infection
MeSH terms: Herpes Simplex
Intervention: 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 description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 8323.0
Sex: Female
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A female between, and including, 18 and 30 years of age at the time of the first
             vaccination.

          -  Written informed consent obtained from the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Seronegative for HSV-1 and HSV-2 by Western blot.

          -  Subject must be non-childbearing potential, i.e. either surgically sterilized or, if
             of child bearing potential, she must be using a highly effective method of birth
             control (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or
             condom in combination with contraceptive jelly, cream or foam; Norplant®;
             DepoProvera®; contraceptive skin patch or cervical ring) for 30 days prior to
             vaccination, have a negative urine pregnancy test and must agree to continue such
             precautions for two months after completion of the vaccination series.

          -  A subject for whom the investigator believes can and will comply with the requirements
             of the protocol (e.g. completion of the memory aid/diary cards, return for follow-up
             visits, accessible by phone or pager, able to self-sample and not planning on moving
             from study area).

        Exclusion Criteria:

          -  Pregnant or nursing female.

          -  Clinical signs or symptoms of current oro-labial, genital or non-genital HSV disease,
             such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema,
             discharge, pain, burning, itching, tingling or dysuria.

          -  Previous vaccination against herpes.

          -  Previous administration of monophosphoryl lipid A (MPL) adjuvant (no vaccines
             currently licensed in the USA contain this).

          -  History of any confirmed oro-labial, genital or non-genital HSV disease or infection.

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Planned administration/ administration of a non-study vaccine within 30 days of the
             first dose of the study vaccine with the following exceptions: Administration of
             routine Meningococcal, Hepatitis B, inactivated Influenza, and Diphtheria/Tetanus
             vaccine up to 8 days before the first dose of study vaccine is allowed.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the study vaccines, e.g. aluminum, MPL, alum-MPL, 2-phenoxyethanol or neomycin.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including,
             human immunodeficiency virus (HIV) infection.

          -  Acute or chronic, clinically significant (unresolved, requiring on-going medical
             management or medication, etc.) pulmonary, cardiovascular, hepatic or renal function
             abnormality, as determined by medical history or physical examination.

          -  Acute disease at the time of enrollment (defer vaccination until subject recovers).
             Acute disease is defined as the presence of a moderate or severe illness with or
             without fever. Study vaccine can be administered to persons with a minor illness such
             as diarrhea, mild upper respiratory infection with or without low-grade febrile
             illness.

          -  Oral temperature greater than or equal to 99.5º F (greater than or equal to 37.5º C) /
             axillary temperature greater than or equal to 99.5º (greater than or equal to 37.5º C)
             / tympanic temperature on oral setting greater than or equal to 99.5º F (greater than
             or equal to 37.5º C).

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose. (For
             corticosteroids, this will mean prednisone or, equivalent, greater than or equal to
             0.5 mg/kg/day. Inhaled or topical steroids are allowed.)

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Recent history of chronic alcohol consumption (defined as more than 5 oz of ethanol
             [absolute alcohol] per day) and/or drug abuse.

          -  History of sexually transmitted infection within 30 days preceding the first dose of
             study vaccine.