Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali

Exclusion Criteria

• •Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β-hCG) test (if female).
• •Currently breastfeeding.
• •Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol.
• •Study comprehension examination score of \<80% correct or per investigator discretion.
• •Hemoglobin, white blood cell, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Subjects may be included at the investigator's discretion for "not clinically significant" values.)
• •Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Subjects may be included at the investigator's discretion for "not clinically significant" values.)
• •Infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• •Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.)
• •Clinically significant abnormal electrocardiogram (ECG; corrected QT interval \[QTc\] \>460 or other significant abnormal findings, including unexplained tachycardia or bradycardia).
• •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
• •Receipt of any investigational product within the past 30 days.
• •Participation or planned participation in an interventional trial with an investigational product until the last required protocol visit. (Note: Past, current, or planned participation in observational studies is NOT exclusionary.)
• •Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
• •History of a severe allergic reaction or anaphylaxis.
• •Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years).
• •Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.
• •Known immunodeficiency syndrome.
• •Known asplenia or functional asplenia.
• •Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \>10 mg/day) or immunosuppressive drugs within 30 days of day 0.
• •Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks prior to study agent administration.
• •Receipt of immunoglobulins and/or blood products within the past 6 months.
• •Previous receipt of an investigational malaria vaccine in the last 5 years.
• •Known allergies or contraindication against artemether-lumefantrine.
• •Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or render the subject unable to comply with the protocol.