Anti-malaria MAb in Kenyan Children
Plasmodium Falciparum Infection · Malaria
Bottom Line
View on ClinicalTrials.gov: NCT05400655 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- L9LS (Drug); Placebo (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local Adverse Events (AEs) |
0; 1; 1; 1; 0; 1 | — |
| PRIMARY Number of Participants With Local Adverse Events (AEs) (by Grade) |
0; 2; 2; 1; 0; 1 | — |
| PRIMARY Number of Participants With Systemic Adverse Events (AEs) |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Systemic Adverse Events (AEs) (by Grade) |
1; 0; 1; 3; 0; 0 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Healthy children aged 5 months to 10 years (Part 1) or 5-59 months (Part 2). Weight ≥5 kg and weight ≤30 kg (Part 1) or weight ≥5 kg and ≤22.5 kg (Part 2) or weight ≥5 kg and ≤20 kg (for 30 mg/kg group) or weight ≥5 kg and ≤15 kg (for 40 mg/kg group), to ensure a maximum volume of two 2-mL (Part 1b) Hemoglobin level ≥8 g/dL. Height and weight Z-scores >-2. Living within Alego-Usonga sub-county. Able to participate for the duration of the trial. Parent and/or guardian of participant able to provide informed consent.
Exclusion Criteria
Individuals meeting any of the following criteria will be excluded from study participation:
Taking long-term cotrimoxazole. Participation or planned participation in any other interventional trial with an investigational product prior to the last required protocol visit or receipt of an investigational product within the past 30 days. (Note: Past, current, or planned participation in observational studies is NOT exclusionary.) Received any doses of any malaria vaccine. Participation in part 1 of this study (for individuals being screened for enrollment into part 2) Age 10 mg/day) or immunosuppressive drugs within 30 days of day 0.
Known asplenia or functional asplenia. Clinical signs of malnutrition. Receipt of immunoglobulins and/or blood products within the past 6 months. 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/guardian study comprehension examination score of <80% correct or per investigator discretion.
Receipt of a live vaccine or a killed vaccine within the past 2 weeks prior to study agent administration.
Known allergies or contraindication to dihydroartemisinin-piperaquine.
Use or known need at the time of pre-enrolment (DP administration) of concomitant prohibited medication, including:
Antimicrobial agents of the following classes (systemic use only):
Macrolides (e.g. erythromycin, clarithromycin, azithromycin, roxithromycin) Fluoroquinolones (e.g., levofloxacin, moxifloxacin, sparfloxacin) Pentamidine Antiarrhythmic agents (e.g. amiodarone, sotalol) Antihistamines (e.g. promethazine) Antifungals (systemic): ketoconazole, fluconazole, itraconazole Antiretrovirals: Saquinavir Diuretics (e.g. hydrochlorothiazide, furosemide) Antipsychotics (neuroleptics): haloperidol, thioridazine Antidepressants: imipramine, citalopram, escitalopram Antiemetics: domperidone, chlorpromazine, ondansetron Increased risk of salivary gland hypofunction (dryness of the mouth, swelling under the tongue and/or below the ear, halitosis) History of any other illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives, or 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.
Data sourced from ClinicalTrials.gov (NCT05400655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.