Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease

Safety of SmithKline Beecham Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL & Its Efficacy to Prevent Genital Herpes Disease in HSV Positive or Negative Consorts of Subjects With Genital Herpes Disease

The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t) with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative consorts of subjects with genital herpes disease.

This study was monitored by a Data Safety Monitoring Board At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Inclusion Criteria:

• Between 18 and 45 years of age at the time of first vaccination
• Written informed consent
• Females of childbearing potential must have a negative pregnancy test at enrollment and be using an accepted method of birth control
• The volunteers must have a regular sexual partner with genital herpes disease confirmed by medical history

Exclusion Criteria:

• Any previous history of or current clinical signs or symptoms of genital herpes disease.
• Any previous vaccination against herpes simplex.
• Any previous administration of MPL.
• History of herpetic keratitis.
• History of erythema multiforme.
• Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose.
• Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
• HIV positive at the time of enrollment
• Clinical signs of acute or febrile illness at the time of entry into the study.
• Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
• Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
• Any vaccine administration less than one week before or after a study vaccination.
• Previous known hypersensitivity to vaccination or to any component of the vaccine.
• Simultaneous participation in any other clinical trial of an investigational compound.
• Recent history of alcoholism or drug abuse
• Recent clinical history or evidence of significant hepatic disease
• Recent clinical history or evidence of renal dysfunction
• Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
• Inability or unwillingness to comply with the protocol or not expected to complete the study period