CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 365 enrolled
Drug / intervention
L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection +2 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/NCT05304611
NCT05304611Phase 2Completed
CompareCT.gov

Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium Falciparum, in a Dose-Escalation Trial in Adults and Children and a Randomized, Double-Blind Trial of Children in Mali

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 31, 2022·Updated Jul 10, 2025

In Brief

A Phase 2 clinical trial evaluating L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection, L9LS (VRC-MALMAB0114-00-AB) intravenous injection, and 1 other intervention for Plasmodium Falciparum Infection and Malaria. Completed, enrolled 365 participants across 2 sites.

Detailed 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.

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
2023202420252026
First PostedMar 31, 2022
Enrollment StartMar 18, 2022
Primary CompletionApr 20, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.3 years ago

Interventions

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

Administered one time via subcutaneous route.

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

Administered one time via intravenous route.

Placeboother

Normal saline administered one time via subcutaneous route.