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

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