CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 490 enrolled
Drug / intervention
L9LS (VRC-MALMAB0114-00-AB) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05816330
NCT05816330Phase 2Completed
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Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium Falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Adults in Mali

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 18, 2023·Updated Apr 2, 2025

In Brief

A Phase 2 clinical trial evaluating L9LS (VRC-MALMAB0114-00-AB) and Placebo for Plasmodium Falciparum Infection and Malaria. Completed, enrolled 490 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. A secondary objective is to determine if SC administration of L9LS at 900 mg (compared to placebo) mediates protection against naturally occurring Pf infection in healthy Malian adult females stratified by weight during a single malaria season.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlasmodium Falciparum Infection, Malaria
CountriesMali
CollaboratorsNational Institutes of Health (NIH), Malaria Research and Training Center, Bamako, Mali, University of the Sciences, Techniques and Technologies of Bamako, University of Washington, Harvard School of Public Health (HSPH), Indiana University

Timeline

Phase 2CompletedFinished
202420252026
First PostedApr 18, 2023
Enrollment StartMay 25, 2023
Primary CompletionFeb 11, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.2 years ago

Interventions

L9LS (VRC-MALMAB0114-00-AB)biological

Administered one time via subcutaneous route.

Placeboother

Normal saline administered one time via subcutaneous route.