Malaria
Conditions
Interventions
L9LS Arm1 Part 1
L9LS Arm2 Part 1
L9LS Arm3 Part 1
L9LS Arm4 Part 1
L9LS Arm5 Part 1
L9LS Arm6 Part 1
Placebo Part 1 children 5 to 10 years
Placebo Part 1 children 5 to 59 months
L9LS Part 2 Arm 1
L9LS Part 2 Arm 2
Placebo Part 2 children 5 to 17 months
L9LS Part 2 Arm 3
L9LS Part 2 Arm 4
Placebo Part 2 children 18 to 59 months
Sponsors
National Institutes of Health
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Taking long-term cotrimoxazole. 2. Participation or planned participation in an interventional trial with an investigational product until the last required protocol visit or receipt of an investigational product within the past 30 days. 4. Participation in part 1 of this study (for individuals being screened for enrollment into part 2) 5. Age < 12 months at the time the RTS,S/AS01 vaccine is anticipated to become available in the whole of Siaya County 6. Current significant medical condition (neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, authoimmune, renal, oncologic, or hematological) or evidence of any other serious underlying medical condition identified by medical history, physical examination, or laboratory examination. 7. Any history of menses. 8. 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. 9. Parental/guardian study comprehension examination score of <80% correct or per investigator discretion. 10. Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks prior to study agent administration. 11. Known allergies or contraindication to dihydroartemisinin-piperaquine. 12. Use or known need at the time of enrolment (DP administration) for concomitant prohibited medication. 13. Increased risk of salivary gland hypofunction (dryness of the mouth, swelling under the tongue and/or below the ear, halitosis) 14. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of local and systemic adverse events (AEs) occurring within 7 days after the administration of L9LS, and incidence of serious adverse events (SAEs) throughout the study period. Age de-escalation and dose-escalation study;Incidence and severity of local and systemic adverse events (AEs) occurring within 7 days after the administration of L9LS, and incidence of serious adverse events (SAEs) throughout the study period. Efficacy study;Pf blood-stage infection as detected by microscopic examination of thick blood smear for 52 weeks after administration of two doses of L9LS or placebo. Efficacy study | — |
Secondary
| Measure | Time frame |
|---|---|
| Pf blood-stage infection as detected by microscopic examination of thick blood smear after administration of one dose of L9LS or placebo. Age de-escalation, dose-escalation and efficacy study;Pf blood-stage infection as detected by microscopic examination of thick blood smear diagnosed by blood smear microscopy after administration of one dose of L9LS or placebo. Age de-escalation, dose-escalation and efficacy study;Pf blood-stage infection as detected by RT-PCR of L9LS or placebo. Age de-escalation, dose-escalation and efficacy study;Incidence of clinical malaria: an illness accompanied by measured fever =37.5°C in the previous 24 hours and Pf asexual parasitemia >5,000 parasites/µL as detected from microscopic examination of thick blood smear. Age de-escalation, dose-escalation and efficacy study;Incidence of clinical malaria: fever =37.5°C, history of fever in the previous 24 hours accompanied by any level of Pf asexual parasitemia, detected from microscopic examination of thick blood smear, requires administration of anti-malarial treatment. Age de-escalation, dose-escalation and efficacy study;Measurement of L9LS in sera of recipients (parts 1 and 2). | — |
Countries
Kenya
Contacts
Public ContactTitus Kwambai
CDC
Outcome results
None listed