| Eligibility |
Inclusion Criteria:
- Is within the appropriate age range for the respective cohort:
1. Children: Aged =6 years and <11 years.
2. Adults: Aged =18 years.
- Able to provide proof of identity to the satisfaction of the study clinician
completing the enrollment process.
- In good general health and without clinically significant medical history.
- Adult participants or parent and/or guardian of minor participants able to provide
informed consent.
- Willing to have blood samples and data stored for future research.
- Resides in or near Kalifabougou or Torodo, Mali, and available for the duration of the
study.
- For the adult cohort, females of childbearing potential must be willing to use
reliable contraception from 21 days prior to study day 0 through the final study visit
as described below.
- Reliable methods of birth control include 1 of the following: confirmed
pharmacologic contraceptives via parenteral delivery or intrauterine or
implantable device.
- Nonchildbearing women will be required to report date of last menstrual period,
history of surgical sterility (i.e., tubal ligation, hysterectomy) or premature
ovarian insufficiency, and will have urine or serum pregnancy test performed per
protocol.
Year 2 Extension Inclusion Criteria:
- Participated in the first year of the protocol.
- Able to provide proof of identity to the satisfaction of the study clinician
completing the enrollment process.
- In good general health and without clinically significant medical history.
- Parent and/or guardian able to provide informed consent.
- Willing to have blood samples and data stored for future research.
- Resides in or near Kalifabougou or Torodo, Mali, and available for the duration of the
study.
Exclusion Criteria:
- Body weight <15 kg or >30 kg for children, or >60 kg for adults.
- Currently receiving or planning to receive seasonal malaria chemoprevention (SMC).
- Any history of menses (for 6-10 year old cohort) or positive pregnancy test at
screening (for adult cohort).
- 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.
- Subject (for adult subjects) or parental (for minor subjects) 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 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 before 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).
- Salivary gland disorder diagnosed by a doctor (e.g., parotitis, sialadenitis,
sialolithiasis, salivary gland tumors).
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to:
systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren'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 or COVID-19
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 or monoclonal antibody in the
last 5 years.
- Known allergies or contraindication against artemether-lumefantrine.
- Clinical signs of malnutrition.
- 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.
Year 2 Extension Exclusion Criteria:
- Currently receiving or planning to receive SMC.
- Any history of menses.
- 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.
- Parental 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 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; 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 another interventional trial with an
investigational product other than L9LS 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).
- Currently active salivary gland disorder diagnosed by a doctor (e.g., parotitis,
sialadenitis, sialolithiasis, salivary gland tumors).
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to:
systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren'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 or COVID-19
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 or any other monoclonal
antibody other than L9LS in the last 5 years.
- Known allergies or contraindication against artemether-lumefantrine.
- Clinical signs of malnutrition.
- 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.
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