Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida

Exclusion Criteria

• •1. Reports receiving any investigational drug, investigational vaccine, or investigational device within 30 days prior to dosing.
• •2. Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
• •3. Clinical laboratory test values outside the accepted range.
• •4. When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
• •5. Reports a clinically significant illness during the 28 days prior to dosing (as determined by the clinical investigators).
• •6. Demonstrates a positive drug screen for non-prescription drugs.
• •7. Reports a history of allergic response(s) to nickel or anaphylaxis (or other serious reactions) to aluminum.
• •8. Reports receiving any live attenuated vaccine including FluMist® within 6 weeks prior to dosing or any licensed inactivated vaccine within 3 weeks prior to dosing.
• •9. Reports the use of any immunosuppressive drugs, including systemic corticosteroids, within 4 weeks prior to dosing.
• •10. Reports the use of any medications or treatments that may alter immune responses to the study vaccine within 3 weeks prior to dosing (e.g., cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin \[BCG\], monoclonal antibodies, radiation therapy).
• •11. Reports a history of clinically significant allergies including food or drug allergies or anaphylaxis (or other serious reactions) to vaccines.
• •12. Reports a history of drug or alcohol addiction or abuse within the past year.
• •13. Reports receiving any blood products within 3 months prior to dosing and throughout the study.
• •14. Reports donating blood within 28 days prior to dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
• •15. Reports donating plasma (e.g. plasmapheresis) within 14 days prior to dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
• •16. Reports an intolerance of direct venipuncture.
• •17. Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study (females only).
• •18. Demonstrates a positive pregnancy screen (females only).
• •19. Any other medical and/or social (e.g. non-compliant) reason which, in the opinion of the investigator(s), would prevent participation in the study.
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