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Last Updated: 19/01/2023
Anti-malaria mAb in Malian Children (L9LS)
Objectives
*Offical Title: 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
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.
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), United States
Vaccine Research Center (VRC), National Institutes of Health (NIH), United States
Malaria Research and Training Center (MRTC), University of Sciences, Techniques and Technologies of Bamako (USTTB), Mali
University of Washington (UW), United States
Harvard T.H. Chan School of Public Health (HSPH), United States
Indiana University (IU) School of Medicine, United States
A two-part, phase 2 trial evaluating 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.
ClinicalTrials.gov Identifier: NCT05304611
Study type: Interventional
Study phase: Phase II
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Enabling Technologies & Assays
Product Development
Vulnerable Populations
Mar 2022 — Mar 2023
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