Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine

Exclusion Criteria

• •On suppressive antiviral medication within 7 days of beginning baseline anogenital swab collection period.
• •History of genital Herpes Simplex Virus type-1 (HSV-1) infection.
• •History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis.
• •Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled corticosteroids \[\> 960 μg/day of beclomethasone dipropionate or equivalent\]) or other immunosuppressive agents.
• •Presence or history of autoimmune disease, regardless of current treatment.
• •Positive serologic test for Human Immunodeficiency Virus (HIV-1) or hepatitis C infection; positive hepatitis B surface antigen (HBsAg).
• •Clinically significant laboratory abnormality or a value ≥ Grade 2.
• •Prior immunization with a vaccine containing HSV-2 antigens.
• •History of hypersensitivity to any component of the vaccine.
• •Receipt of any investigational drug within 30 days prior to the first dose of Study Drug.
• •Receipt of blood products within 90 days prior to the first dose of Study Drug.
• •Receipt of a live vaccine within 28 days prior to or a subunit vaccine within 14 days prior to the first dose of Study Drug or planned vaccination within 30 days following the last dose of Study Drug.
• •Pregnant or nursing women.
• •History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.
• •Other active, uncontrolled co-morbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
• •NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to the first dose of Study Drug.