A Study to Determine Whether 2 Investigational Malaria Vaccines Are Safe, Protective Against Malaria in Adults

Exclusion Criteria

• •Prior receipt of an investigational malaria vaccine
• •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization or planned use during the study period, or receipt of investigational vaccine containing 3-D MPL and/or QS-21 at any time in the past (Have you received an experimental vaccine with a GSK adjuvant in the past?)
• •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of immunization. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• •Chronic use of antibiotics with anti-malarial effects (e.g., tetracyclines for dermatologic patients, sulfa for recurrent urinary tract infections, etc.)
• •Planned administration of a vaccine not foreseen by the study protocol 30 days prior to or after the first immunization
• •History of malaria chemoprophylaxis within 60 days prior to immunization
• •Any history of malaria
• •Known exposure to malaria within the previous 12 months
• •Planned travel to malarious areas during the study period
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• •History of allergic disease or reactions to any vaccine
• •Chronic or active neurologic disorders including seizures, excluding a single febrile seizure as a child
• •History of splenectomy
• •Acute disease at the time of enrollment (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature \< 37.5°C/99.5°F).
• •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
• •Personal medical histories including the following diagnoses: systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, scleroderma, vasculitis, and multiple sclerosis
• •Seropositive for hepatitis B surface antigen or hepatitis C antibody
• •Hepatomegaly, right upper quadrant abdominal pain or tenderness
• •Elevated serum creatinine, defined in this study as greater than or equal to 1.7 mg/dL in males and 1.4 mg/dL in females
• •Significant unexplained anemia: hematocrit \< 35%
• •Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period
• •Pregnant or lactating female or female who intends to become pregnant during the study
• •Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV (Diagnostic and Statistical Manual of Mental Disorders- 4th edition)
• •Chronic or active illicit and/or intravenous drug use
• •History of severe anaphylactic reactions to mosquito bites
• •History of psoriasis (given its interaction with chloroquine)
• •Any history of anaphylaxis in reaction to immunization
• •History of allergy to nickel, imidazole or tetracycline group of antibiotics
• •History of sickle cell disease or sickle cell trait
• •Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study