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L9LS MAb in Malian Infants

NCT06461026 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-09-25

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.

Conditions

Interventions

BIOLOGICAL

L9LS

Administered intramuscularly one time.

OTHER

Normal Saline

Administered intramuscularly one time.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Washington

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Indiana University School of Medicine, Indiana University

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
1 Month
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2025-06-27
Completion
2026-06-30
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 NCT06461026 on ClinicalTrials.gov