HSV529 Vaccine in HSV-2 Seropositive Adults

Exclusion Criteria

• •1. Subject is pregnant or nursing OR planning to become pregnant in the timeframe that begins 30 days prior to the first vaccination and ends 30 days after the third vaccination.
• •2. Body Mass Index greater than 35.
• •3. Hepatitis C seropositive
• •4. Hepatitis B surface antigen positive
• •5. Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination or planned participation during the study period up to 6 months after the last dose of vaccine. The non-interventional follow-up for an earlier study (e.g., long-term surveillance) will be allowed.
• •6. Severe active infection or serious HSV-2 related or unrelated medical conditions that, in the opinion of the investigator, would prevent study completion.
• •7. Subjects with 9 or more symptomatic recurrences of genital herpes disease within the year prior to Day 0.
• •8. A history of HSV infection of the eye (e.g., herpes simplex interstitial keratitis or uveitis).
• •9. A history of herpes gladiatorum, herpetic whitlow or eczema herpeticum.
• •10. A history of lesions caused by HSV on either arm.
• •11. A history of herpes-associated erythema multiforme.
• •12. A history of a clinically significant autoimmune disorder.
• •13. Known or suspected congenital or acquired immunodeficiency.
• •14. Receipt of anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
• •15. Subjects using corticosteroids (excluding topical, inhaled or nasal) or any immunomodulating drugs (see Prohibited Medications Section) within 42 days prior to the first vaccination. An immunosuppressive dose of corticosteroids is defined as ≥10 mg prednisone equivalent per day for \>14 days.
• •16. Subjects without a spleen.
• •17. Subjects receiving immunoglobulin within the past 6 months or anticipated receipt of immunoglobulin during the 28 days following each vaccination.
• •18. Bleeding disorder, or receipt of anticoagulants that, in the opinion of the Investigator, would interfere with the subject's participation in the trial.
• •19. Known allergy or intolerance to vaccine components \[e.g., potassium glutamate (possible cross-reaction to monosodium glutamate), sucrose\] or to a vaccine containing any of the same substances.
• •20. Known allergy or intolerance to silver nitrate or lidocaine.
• •21. Known allergy or intolerance to acyclovir or valacyclovir.
• •22. Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
• •23. History of keloid formation or excessive scarring.
• •24. History of frequent cellulitis or boils (\>3 episodes in past 2 years) requiring antibiotic therapy.
• •25. Prior receipt of an HSV vaccine.
• •26. Any condition that the PI thinks might compromise the person's ability to comply with the requirements of the study.