Blood-Stage Plasmodium Vivax Cell Bank

• INCLUSION CRITERIA:

All of the following criteria must be fulfilled for a participant to participate in this trial:

• Age >=18 and =80% or per investigator s discretion) and reviewed prior to enrollment.
• Reliable access to the NIH CC and availability to participate for duration of study.
• Females of childbearing potential must be willing to use reliable contraception (as defined below) from 21 days prior to study Day 0 to 28 days following IBSM.
• Sign written informed consent prior to undertaking any study-related procedure.

EXCLUSION CRITERIA

A participant will be excluded from participating in this trial if any one of the following criteria is fulfilled:

• Currently breastfeeding (if female).
• Pregnant as determined by a positive urine or serum human choriogonadotropin (Beta-hCG) test (if female).
• Planned travel to a malaria-endemic area during the study period and up to 2 weeks following the EOS visit.
• History of recent travel to or residence in a P. vivax malaria-endemic region for more than 2 weeks during the past 5 years.
• Planned travel to a malaria-endemic region during the course of the study (for endemic regions, see www.cdc.gov/malaria/travelers/country\_table).
• Any history of confirmed malaria diagnosis on peripheral blood smear or by clinical history
• Participation in a previous malaria challenge study.
• Screening laboratory parameters outside of local lab normal range, to include serum-corrected calcium, creatinine, hepatic transaminase enzymes (ALT, AST), total bilirubin (unless the participant has documented Gilbert syndrome), and hemoglobin. Participants may be included at the investigator s discretion for not clinically significant values outside of normal range.
• Abnormal urinalysis as defined by positive urine glucose, protein, and hemoglobin. Participant can be included if investigator determine the abnormality is not clinically significant.
• Duffy blood group negative (male or female).
• ABO blood type other than O (male or female).
• Rh blood group negative (females of childbearing potential).
• Anticipated use during the study period, or use within the following periods prior to enrollment of any of the following: Investigational malaria vaccine within the last 2 years; Malaria chemoprophylaxis within the past 6 months; Chronic systemic immunosuppressive medications (>14 days) within 6 months; Blood products or immunoglobulins within the previous 6 months; Systemic antibiotics or medications with potential antimalarial effects within the past 6 weeks; Investigational or non-registered product or vaccine within 30 days; Receipt of any vaccination within 28 days prior to P. vivax IBSM; Medications known to interact with artemether/lumefantrine; Anticoagulants within the past 28 days.
• History of:
• Sickle cell disease, sickle cell trait, or other hemoglobinopathies.
• Splenectomy or functional asplenia.
• Systemic anaphylaxis.
• Any allergic reactions to artemether/lumefantrine, chloroquine (or any 4-aminoquinolines), artemether or other artemisinin derivatives, or their excipients.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
• Blood transfusion.
• Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status and participation in the study in the opinion of the investigator.
• Vital signs taken after 5 minutes of resting in seated or supine position that fall outside the following ranges:
• Systolic blood pressure =140 mm Hg.
• Diastolic blood pressure =90 mm Hg.
• Heart rate =100 bpm.
• Body mass index less than 17.0 or greater than 35.0 kg/m2 at the time of screening.
• History of, or known active cardiac