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Anti-malaria MAb in Kenyan Children

NCT05400655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 912

Last updated 2025-10-16

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective efficacy of one or two doses of L9LS against naturally occurring Plasmodium falciparum (Pf) infection among Kenyan children aged 5 to 59 months at enrollment, in a setting of perennial high transmission.

Conditions

  • Plasmodium Falciparum Infection
  • Malaria

Interventions

DRUG

L9LS

Administered subcutaneously.

OTHER

Placebo

Normal saline administered subcutaneously.

Sponsors & Collaborators

  • Centers for Disease Control and Prevention

    collaborator FED

  • National Institutes of Health (NIH)

    collaborator NIH

  • Kenya Medical Research Institute

    collaborator OTHER

  • Liverpool School of Tropical Medicine

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Titus Kwambai, MD, PhD · Centers for Disease Control and Prevention

  • Laura Steinhardt, PhD, MPH · Centers for Disease Control and Prevention

  • Peter D Crompton, MD, MPH · National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2024-06-02
Completion
2024-06-02
FDA Drug
Yes

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05400655 on ClinicalTrials.gov