Anti-malaria MAb in Kenyan Children

Inclusion Criteria:

1. Healthy children aged 5 months to 10 years (Part 1) or 5-59 months (Part 2).

2. Weight ≥5 kg and weight ≤30 kg (Part 1) or weight ≥5 kg and ≤22.5 kg (Part 2).

3. Hemoglobin level ≥8 g/dL.

4. Height and weight Z-scores >-2.

5. Living within Alego-Usonga sub-county.

6. Able to participate for the duration of the trial.

7. Parent and/or guardian of participant able to provide informed consent.

Exclusion Criteria:

1. Taking long-term cotrimoxazole.

2. Participation or planned participation in an interventional trial with aninvestigational product until the last required protocol visit or receipt of aninvestigational product within the past 30 days. (Note: Past, current, or plannedparticipation in observational studies is NOT exclusionary.)

3. Received any doses of any malaria vaccine.

4. Participation in part 1 of this study (for individuals being screened for enrollmentinto part 2)

5. Age < 12 months at the time the RTS,S/AS01 vaccine is anticipated to becomeavailable in the whole of Siaya County

6. Current significant medical condition (neurologic, cardiac, pulmonary, hepatic,endocrine, rheumatologic, authoimmune, renal, oncologic, or hematological) orevidence of any other serious underlying medical condition identified by medicalhistory, physical examination, or laboratory examination.

7. Known sickle cell disease. (Note: Known sickle cell trait is NOT exclusionary.)

8. Hemoglobin, white blood cell, absolute neutrophil, or platelet count outsidethe local laboratory-defined limits of normal. (Subjects may be included at theinvestigator's discretion for "not clinically significant" values.)

9. Alanine transaminase (ALT) or creatinine (Cr) level above the locallaboratory-defined upper limit of normal. (Subjects may be included at theinvestigator's discretion for "not clinically significant" values.)

10. Infected with HIV.

11. History of a severe allergic reaction or anaphylaxis.

12. Severe asthma (defined as asthma that is unstable or required emergency care,urgent care, hospitalization, or intubation during the past 2 years, or thathas required the use of oral or parenteral corticosteroids at any time duringthe past 2 years).

13. Pre-existing autoimmune or antibody-mediated diseases including but not limitedto: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis,Sjogren's syndrome, or autoimmune thrombocytopenia.

14. Known immunodeficiency syndrome.

15. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical ornasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) orimmunosuppressive drugs within 30 days of day 0.

16. Known asplenia or functional asplenia.

17. Clinical signs of malnutrition.

18. Receipt of immunoglobulins and/or blood products within the past 6 months.

19. Any history of menses.

20. Behavioral, cognitive, or psychiatric disease that in the opinion of theinvestigator affects the ability of the subject to understand and comply with thestudy protocol.

21. Parental/guardian study comprehension examination score of <80% correct or perinvestigator discretion.

22. Receipt of a live vaccine within the past 4 weeks or a killed vaccine within thepast 2 weeks prior to study agent administration.

23. Known allergies or contraindication to dihydroartemisinin-piperaquine.

24. Use or known need at the time of enrolment (DP administration) for concomitantprohibited medication. Patients taking any of the following drugs: a. Antimicrobial agents of the following classes (systemic use only): i. Macrolides (e.g. erythromycin, clarithromycin, azithromycin, roxithromycin) ii.Fluoroquinolones (e.g., levofloxacin, moxifloxacin, sparfloxacin) iii. Pentamidineb. Antiarrhythmic agents (e.g. amiodarone, sotalol) c. Antihistamines (e.g.promethazine) d. Antifungals (systemic): ketoconazole, fluconazole, itraconazole e.Antiretrovirals: Saquinavir f. Diuretics (e.g. hydrochlorothiazide, furosemide) g.Antipsychotics (neuroleptics): haloperidol, thioridazine h. Antidepressants:imipramin, citalopram, escitalopram i. Antiemetics: domperidone, chlorpromazine,ondansetron

25. Increased risk of salivary gland hypofunction (dryness of the mouth, swelling underthe tongue and/or below the ear, halitosis)

26. History of any other illness or condition which, in the investigator's judgment, maysubstantially increase the risk associated with the subject's participation in theprotocol or compromise the scientific objectives, or other condition(s) that, in theopinion of the investigator, would jeopardize the safety or rights of a subjectparticipating in the trial, interfere with the evaluation of the study objectives,or render the subject unable to comply with the protocol.