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Anti-malaria MAb in Malian Children

NCT05304611 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2025-07-10

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of onetime subcutaneous (SC) or intravenous (IV) administration of monoclonal antibody (MAb) L9LS in healthy Malian adults and one-time SC administration of L9LS in healthy Malian children, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 7-month malaria season in healthy Malian children 6-10 years of age.

Conditions

  • Plasmodium Falciparum Infection
  • Malaria

Interventions

BIOLOGICAL

L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection

Administered one time via subcutaneous route.

BIOLOGICAL

L9LS (VRC-MALMAB0114-00-AB) intravenous injection

Administered one time via intravenous route.

OTHER

Placebo

Normal saline administered one time via subcutaneous route.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • University of the Sciences, Techniques and Technologies of Bamako

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Indiana University School of Medicine

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kassoum Kayentao, MD, MPH, PhD · Faculté de Médecine Pharmacie d'Odontostomatologie (FMPOS)

  • Peter Crompton, MD, MPH · National Institutes of Health (NIH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2024-04-20
Completion
2024-04-20
FDA Drug
Yes

Countries

  • Mali

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 NCT05304611 on ClinicalTrials.gov