Anti-malaria Monoclonal Antibody for Malaria Prevention in Kenyan childre

Phase 2

Recruiting

• Conditions: Malaria

• Registration Number: PACTR202205899641128
• Lead Sponsor: ational Institutes of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 396

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of local and systemic adverse events (AEs) occurring within 7 days after the administration of<br>L9LS, and incidence of serious adverse events (SAEs) throughout the study period.<br>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<br>L9LS, and incidence of serious adverse events (SAEs) throughout the study period.<br>Efficacy study;Pf blood-stage infection as detected by microscopic examination of thick blood smear for 52 weeks after administration<br>of two doses of L9LS or placebo. Efficacy study