Phase I Study of AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909 Malaria Vaccine

Exclusion Criteria

• •1. Pregnancy as determined by a positive urine beta-hCG at any time during the study (if female).
• •2. Participant unwilling to use reliable contraception methods for at least 2 weeks prior to vaccination and for the duration of the trial. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; intrauterine device; abstinence; and post-menopause (if female).
• •3. Currently breast-feeding (if female).
• •4. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
• •5. Neutropenia as defined by an absolute neutrophil count less than 1500/mm(3).
• •6. Alanine aminotransaminase (ALT) level above the laboratory-defined upper limit of normal.
• •7. Serum creatinine level above the laboratory-defined upper limit of normal.
• •8. Hemoglobin below the laboratory-defined lower limit of normal, by sex.
• •9. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
• •10. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
• •11. History of receiving any investigational product within the past 30 days.
• •12. Participant has had medical, occupational or family problems as a result of alcohol or illicit drug use during the past 12 months.
• •13. History of a severe allergic reaction or anaphylaxis.
• •14. Positive ELISA and confirmatory Western blot tests for HIV-1.
• •15. Positive ELISA and confirmatory immunoblot tests for hepatitis C virus (HCV).
• •16. Positive hepatitis B surface antigen (HBsAg) by ELISA.
• •17. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
• •18. Known immunodeficiency syndrome.
• •19. Positive serum anti-dsDNA titer.
• •20. Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
• •21. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
• •22. History of a surgical splenectomy.
• •23. Receipt of blood products within the past 6 months.
• •24. Previous receipt of an investigational malaria vaccine.
• •25. Receipt of antimalarial prophylaxis during the past 12 months, or receipt of chloroquine or related compounds (amodiaquine or primaquine) in the previous 8 weeks prior to study entry.
• •26. Prior malaria infection.
• •27. Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives.
• •28. History of a known allergy to nickel.