Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants

Exclusion Criteria

• •1. Known or suspected immunodeficiency (e.g. HIV infection, significant risk factors for HIV, primary immunosuppressive disorder), use of immunosuppressive or antineoplastic drugs except corticosteroids used for indications other than immunosuppression.
• •2. Clinically significant laboratory abnormality (greater than 1.5 upper limit of normal.).
• •3. Serology positive for HIV, hepatitis B surface antigen or hepatitis C antibody.
• •4. History of leukemia, lymphoma or other malignancy.
• •5. Clinically significant cardiac, respiratory, renal, hepatic, neurological disorder
• •6. Pregnant or lactating females (women of childbearing potential will undergo a pregnancy test).
• •7. Receipt of any vaccine within 30 days.
• •8. History of drug or alcohol dependence, or significant acute or chronic medical or psychiatric illness which would limit the subject's ability to complete the study and/or compromise the objectives of the study.
• •9. Fever or acute illness within 3 days prior to treatment. (These subjects can be rescheduled for treatment at a later date).
• •10. Participation in another investigational drug or vaccine trial within 30 days.