Study of Na-ASP-2 Human Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection

Exclusion Criteria

• •Any history of anaphylaxis or allergy to vaccine components or allergy to insect stings, including bee stings.
• •A past or current history of hookworm infection.
• •BMI \< 18.0 or \> 30.0.
• •Recent (\< 72 hours) history of febrile illness at the time of vaccination (temperature \> 99.6°F or equivalent).
• •Received any immune globulin or blood product 3 months prior to injection or scheduled within 4 weeks thereafter.
• •Had vaccination with a live virus vaccine within 4 weeks before receipt of the vaccine or scheduled within 4 weeks thereafter.
• •Had vaccination with a killed vaccine, or allergy treatment with antigen injections within 14 days of initial study injection.
• •Received an investigational agent within 4 weeks of initial study injection.
• •Known or suspected impairment of immunologic function including, but not limited to clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment (creatinine \> 1.5), any history of malignancy (except squamous cell or basal cell skin cancer), HIV infection or autoimmune diseases, or concomitant immunosuppressive medication such as glucocorticosteroids.
• •A history of essential hypertension, gastrointestinal abnormalities such as peptic ulcer disease, cardiac (ECG abnormalities), pulmonary, hepatic, renal, pancreatic, or neurologic disease.
• •Taken prescription medications with the exception of subjects on a stable regimen (\> 30 days) of: (1) hormone replacement therapy, (2) use of nasal steroids, (3) topical therapy, (4) certain classes of antidepressants (i.e., selective serotonin re-uptake inhibitors), (5) oral contraceptives, (6) nonsteroidal anti-inflammatory agents, or (7) antihistamines or decongestants for seasonal allergies taken as needed.
• •Contraindication to IM injection such as anti-coagulant therapy or thrombocytopenia.
• •Pregnant, nursing, or expecting to conceive during the study.
• •Any history of chronic alcohol or drug abuse or current treatment with any known prescribed or over-the-counter supplements that may be hepatotoxins.
• •Any subject who, in the Investigator's opinion, will be unable to adhere to protocol requirements.