PfSPZ Vaccine Trial in Malian Children

Inclusion Criteria

• Parent(s) or guardian(s) willing and able to provide consent prior to initiation of any study procedures
• Stated willingness of parent(s) or guardian(s) to comply with all study procedures and availability for the duration of the study
• Malaria comprehension exam completed by parent(s) or guardian(s) and passed with a score of ≥80% or per investigator's discretion
• Healthy children 6-10 years of age at enrollment (inclusive)
• Parent(s) or guardian(s) are able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Willing to have blood samples stored for future research

Exclusion Criteria

• Medical, behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant's parent and/or legal guardian to understand and comply with the study protocol
• Menstruating females (in order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group)
• Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratory-defined limits of normal and ≥ Grade 2 (subjects may be included at the investigator's discretion for 'not clinically significant' abnormal values)
• Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and ≥ Grade 2 (subjects may be included at the investigator's discretion for 'not clinically significant' abnormal values)
• Infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Sickle cell disease by history
• Taking or planning to take seasonal malaria chemoprophylaxis
• Clinically significant abnormal electrocardiogram (ECG) such as abnormal QTc
• History of receipt of the following:
• Investigational malaria vaccine in the last 2 years
• Immunoglobulins and/or blood products within 6 months of enrollment
• Investigational product within 3 months of enrollment
• Chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone ≥20 mg/day or equivalent) or immunosuppressive drugs within 30 days of enrollment
• Live vaccine within 30 days of enrollment
• Killed vaccine within 14 days of enrollment or planned receipt of a killed vaccine within 14 days of scheduled vaccination
• Known medical problems:
• Pre-existing autoimmune or antibody-mediated diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia)
• Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years)
• Immunodeficiency disorder
• Asplenia or functional asplenia
• Diabetes
• Deep venous thrombosis or thromboembolic event
• Seizures (exception is simple febrile seizures during childhood)
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies