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

Inclusion Criteria:

• A male or non-pregnant female 18 to 50 years of age (inclusive) at the time of screening.
• Free of significant health problems as established by medical history and clinical examination before entering into the study.
• Available to participate for duration of study (approximately 7 months).
• If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be capable of preventing pregnancy, have a negative pregnancy test at the time of each immunization, and must agree to continue such precautions for 2 months after completion of the immunization series.
• Written informed consent must be obtained from the subject before screening procedures.
• Test of Understanding.(Phase 1a only)
• In the phase 1a, prior to entry into this study, subjects must score at least 80% correct on a ten question multiple-choice quiz that assesses their understanding of this study. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them to ensure comprehension and they will have the opportunity to retest. If a volunteer fails to correctly answer 8 of 10 questions after two attempts they will be excluded from the study.

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 immunization. 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 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.

  • ALT above normal range
  • Creatinine above normal range
  • Hemoglobin below normal range
  • Platelet count below normal range
  • 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.
• For the Phase 1a, any past history of malaria or planned travel to malarious areas during the study period was exclusionary.