Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults

• Healthy adults (male or non-pregnant, non-lactating female) 18 to 50 years of age at the time of screening
• If the subject is female,
• Non-childbearing potential , abstinent or using adequate contraceptive precautions during this study and must agree to continue such precautions until three months after challenge
• A negative pregnancy test at the time of enrollment
• Free of significant health problems as established by medical history, laboratory, and clinical examination before entering the study
• Low cardiac risk factors
• Available to participate and reachable by phone for duration of study (approximately 8 months)
• No plans to travel to outside the Washington DC area between the day of challenge and either completion of treatment course (post-challenge) or, if subject remains uninfected, 28 days post-challenge
• No plans to travel to a malaria endemic area during the course of the study
• Written informed consent must be obtained from the subject before screening procedures
• Subjects must score at least 80% correct on a multiple-choice quiz that assesses their understanding of this study
• Active duty military must obtain approval from his or her supervisor

Exclusion Criteria

• History of malaria infection
• History of travel to P. falciparum endemic areas in the 3 months prior to day of first vaccination or day of challenge
• History of receiving a malaria vaccine
• Receipt of any licensed vaccine within 7 days prior to first vaccination
• History of receipt of malaria prophylaxis during the 2 months prior to day of first vaccination or day of challenge
• History of use of any drugs with significant antimalarial activity during the course of the study period
• Prior receipt of any vaccine containing either QS-21, MPL or GLA-SE in the previous 5 years (including Cervarix®, GSK)
• Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period.
• Any history of allergic reaction or anaphylaxis to previous vaccination
• Allergy to kanamycin, nickel, or imidazole Pregnant or lactating female at screening or plans to become pregnant or breastfeed from the time of enrollment until three months after challenge
• Allergy to antimalarial drugs or use of medications known to interact with both CQ and artemether/lumefantrine
• Significant (eg, systemic) hypersensitivity reactions to mosquito bites
• History of sickle cell disease
• History of psoriasis or porphyria
• History of splenectomy
• Any confirmed or suspected immunodeficiency, including HIV infection
• Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune-modifying drugs within six months of vaccination
• Inhaled and topical steroids are allowed
• A family history of congenital or hereditary immunodeficiency
• Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by history, physical examination, or laboratory evaluation
• Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or any planned administration during the study period
• Any abnormal baseline laboratory screening tests listed below (normal values are defined in the adverse event section of this protocol):
• Seropositive for HIV or Hepatitis C virus or HBsAg positive
• Hepatomegaly, right upper quadrant abdominal pain or tenderness
• An abnormal baseline screening EKG.
• Suspected or known current alcohol or drug abuse as determined from the medical history or by physical examination
• Any other significant finding that in the opinion of the PI would increase the risk of having an adverse outcome from participating in this study