V710 First-In-Man (FIM) Study (V710-001)

Inclusion Criteria

• Subject is 18 to 55 years of age
• Subject is in good physical health based upon medical history, physical examination, and screening laboratory studies. NOTE: Lab studies will only be collected in Panel A, the dose-escalating portion of the study
• Subject is able to understand study procedures and agrees to participate in the study by providing written informed consent
• Subject is willing and able to participate in the entire study duration planned for 3 months (~84 days)
• Female subjects are required to have a negative urine pregnancy test immediately prior to study vaccination. Female subjects of childbearing potential must have been using an acceptable method of birth control for 2 weeks prior to enrollment, and agree to use an acceptable method of birth control for 1 month after vaccination. (Acceptable methods of birth control include use of hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or abstinence)

Exclusion Criteria

• Subject suffers from a chronic skin condition that predisposes the individual to the development of chronic skin or soft-tissue infections (e.g., psoriasis, chronic granulomatous disease).
• Subject developed a serious infection (e.g., bacteremia, pneumonia, mediastinitis) attributed to S. aureus in the 12 months prior to screening
• Subject has a history of anaphylaxis to aluminum-containing adjuvant or other vaccine components
• Subject has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to receipt of 0657nI S. aureus vaccine/placebo
• Subject has received a live virus vaccine within 30 days prior to receipt of 0657nI S. aureus vaccine/placebo or is scheduled to receive vaccination with a live virus vaccine within 30 days following study entry
• Subject has received any other licensed vaccine (including non-live virus vaccines) within 14 days prior to receipt of 0657nI S. aureus vaccine/placebo or is scheduled to receive any other licensed vaccine (including non-live virus vaccines) within 30 days following study entry. (Note: Influenza vaccines may be administered during the study, but must be given at least 7 days prior to receipt of the study vaccine or at least 15 days after receipt of the study vaccine)
• Subject was administered immunoglobulin or blood product within 90 days prior to receipt of 0657nI S. aureus vaccine/placebo or is scheduled to receive such products within 30 days following study entry
• Subject has received treatment with systemic (intramuscular, oral, or intravenous) corticosteroids or another immunosuppressive medication (e.g., calcineurin inhibitors, mycophenolate, azathioprine) in the 14 days prior to receipt of 0657nI S. aureus vaccine/placebo or is anticipated to receive such medications for a chronic medical condition during the course of the study
• Subject has a condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being, such as diabetes mellitus, autoimmune disease, or clinically significant chronic medical conditions that are considered progressive, including but not limited to: coronary artery disease, congestive heart failure, cardiomyopathy, progressive valvular heart disease, chronic obstructive pulmonary disease, pulmonary fibrosis, active peptic ulcer disease, chronic renal disease, chronic hepatic disease, multiple sclerosis, progressive neuropathies, or seizure disorder requiring therapy in the past 3 years
• Subject has known or suspected impairment of immunologic function including, but not limited to, the following conditions: autoimmune disease, diabetes mellitus, end-stage renal disease, hepatic insufficiency/cirrhosis, splenectomy, or HIV/AIDS
• Subject has a condition in which repeated venipuncture or injections pose more than minimal risk for the subject, such as hemophilia, other severe coagulation disorders, or significantly impaired venous acces