A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya

Exclusion Criteria

• •Prior receipt of any investigational malaria vaccine
• •Prior receipt of a vaccine containing either QS-21, MPL or AS02 or AS01
• •Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
• •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. For corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
• •Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the study vaccine
• •Any past history of malaria
• •Planned travel to malarious areas during the study period
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• •A family history of congenital or hereditary immunodeficiency
• •Chronic or active neurologic disease including seizure disorder
• •History of splenectomy
• •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or abnormal baseline laboratory screening tests
• •1. ALT above normal range
• •2. Creatinine above normal range
• •3. Hemoglobin below normal range
• •4. Platelet count below normal range
• •5. Total white cell count below normal range
• •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 or mild upper respiratory infection without fever, i.e., Oral temperature \< 37.5°C.
• •Hepatomegaly, right upper quadrant abdominal pain or tenderness
• •Seropositive for HIV, Hepatitis C virus (antibodies to HCV) and/or HBsAg
• •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
• •Pregnant or lactating female
• •Suspected or known current alcohol abuse/drug abuse as obtained by history and physical examination
• •Female who is willing or intends to become pregnant during the study
• •Any history of allergic reaction or anaphylaxis to previous vaccination
• •Inability to make follow-up visits or complete diary cards
• •Allergy to kanamycin, nickel, or imidazole
• •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