L9LS-R21 Interaction

Summary

This is a randomized, double-blind, placebo-controlled trial in 2 parts evaluating the effect of 1-time administration of the monoclonal antibody (MAb) L9LS to healthy Malian participants on the immunogenicity of subsequent administration of the R21/Matrix-M™ vaccine. L9LS will be administered subcutaneously (SC) for adults and infants. The study will assess how the timing of L9LS administration impacts immunogenicity following subsequent intramuscular (IM) R21/Matrix-M™ vaccination. Twenty-four adult participants and 333 infant participants will be enrolled.

Conditions

• Malaria

Interventions

DRUG

Single dose of 1800 mg L9LS SC (12mL)

A human monoclonal antibody to protect against Plasmodium falciparum.

OTHER

Placebo 12 mL SC

Normal saline.

DRUG

Single dose of 225 mg L9LS SC (1.5mL)

A human monoclonal antibody to protect against Plasmodium falciparum.

OTHER

Placebo 1.5 mL SC

Normal saline.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Malaria Research and Training Center (MRTC)

  collaborator UNKNOWN

• Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)

  collaborator UNKNOWN

• University of Sciences, Techniques, and Technologies of Bamako (USTTB)

  collaborator UNKNOWN

• University of Washington

  collaborator OTHER

• Indiana University School of Medicine, Indiana University

  collaborator UNKNOWN

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Bickey H Chang, MD, MHA · LIG/NIAID/NIH

• Kassoum Kayentao, MD, MPH, PhD · MRTC/FMOS/USTTB

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

5 Months

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2028-03-31

Completion

2029-03-31

FDA Drug

Yes

Countries

• Mali

Study Locations