Clinical Research Directory

Inclusion Criteria: 1. Females of childbearing potential aged ≥ 18 and ≤ 38 years 2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process 3. In good general health and without clinically significant medical history 4. Willing to have blood samples stored for future research 5. Available for the duration of the study 6. Must be willing to use reliable contraception (defined as: pharmacologic contraceptives \[parental delivery\] or pre-existing intrauterine or implantable device) from 21 days prior to first vaccination (study day 1) to 28 days after last vaccination (study day 57) 7. Willingness to undergo HIV testing 8. Report being interested in becoming pregnant within the next 1 year Exclusion Criteria: 1. Pregnancy at the time of enrollment/vaccination, as determined by a positive urine or serum human chorionic gonadotropin (β-hCG) test 2. Biologically unable to become pregnant secondary to: surgical sterilization, premature ovarian insufficiency (defined as no menses for ≥12 months without an alternative medical cause) 3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol 4. Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratorydefined limits of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values) 5. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values) 6. Infected with human immunodeficiency virus (HIV) 7. Known or documented sickle cell disease by history (Note: known sickle cell trait is NOT exclusionary) 8. Clinically significant abnormal electrocardiogram (ECG) such as abnormal QTc. 9. 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 10. History of receiving any investigational product within the past 30 days 11. Participation or planned participation in a clinical trial with an investigational product prior to completion of the follow-up visit 28 days following last vaccination OR planned participation in an investigational vaccine study until the last required protocol visit 12. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months 13. History of a severe allergic reaction (Grade 2 or higher or per PI discretion) or anaphylaxis 14. 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) 15. 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 16. Known immunodeficiency syndrome 17. Known seizure disorder or history of seizures (exclusion: simple febrile seizure during childhood) or history of migraine headaches 18. Laboratory evidence of hepatitis B or C 19. Known asplenia or functional asplenia 20. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone ≥20 mg/day) or immunosuppressive drugs within 30 days of vaccination 21. Receipt of a live vaccine within the past four weeks or a killed vaccine within the past two weeks prior to Vaccination #1 and every subsequent vaccination day 22. Receipt of immunoglobulins and/or blood products within the past six months 23. Previous receipt of an investigational malaria vaccine in the last ten years 24. Known allergies or other contraindications against use of artemether/lumefantrine 25. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the participant unable to comply with the protocol