A Phase I/IIa, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study of the Safety and Immunogenicity of a HSV-2 Vaccine Containing Matrix M-2 Adjuvant in Individuals With Documented Genital HSV-2 Genital Infection

Fecha de inicio: 1 de julio de 2012

Inclusion Criteria: Men and women ages 18 to 50 years, inclusive. Willing to practice a highly effective method of contraception that includes the use of a barrier method such as a condom. Diagnosis of genital HSV-2 infection for > 1 year supported by ONE of the following documented in the medical history or performed at screening: Western blot for HSV-2 Type-specific polymerase chain reaction (PCR) or viral culture Compatible clinical history AND HSV-2 ELISA (HerpSelect) index value >3.5 A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive therapy, history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation suppressive therapy. Good general health status as determined by screening evaluation completed within 90 days prior to immunization. Any out of range screening clinical laboratory values should be considered not clinically significant by the Investigator. Patient has provided written informed consent. Ability and willingness to perform and comply with all study procedures including attending clinic visits as scheduled. Note: patients must provide, by the day of randomization, a minimum of 28 (equivalent of 14 days) baseline viral swab samples to continue to be eligible and be randomized). Exclusion Criteria: On suppressive antiviral medication within 7 days of baseline viral shedding evaluation. Immunocompromised individuals, including those receiving systemic corticosteroids or other immunosuppressive agents. Positive serologic test for HIV-1 infection; positive hepatitis B surface antigen (HBsAg) or antibody for hepatitis C (anti-HCV). Active lesions consistent with herpetic disease at the time of scheduled immunization. Pregnant or nursing women. Receipt of any investigational drug within 30 days of the first scheduled day of immunization. History of hypersensitivity to any component of the vaccine. History of genital HSV-1 infection. History of: (1) any form of ocular HSV infection, (2) HSV-related erythema multiforme, or (3) herpes meningitis or encephalitis. Any other condition which in the opinion of the Investigator would interfere with the successful completion of the study protocol. 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. Prior immunization with a vaccine containing HSV-2 antigens. Receipt of blood products within 90 days of the first immunization.