Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali
This is a phase 2 trial evaluating the safety and tolerability of a 1-time subcutaneous (SC) administration of L9LS, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. The primary study hypothesis is that L9LS will be safe and protective against malaria infection. As a secondary objective, the efficacy of L9LS among female participants of childbearing potential within three body weight strata will be compared to placebo. Before study agent administration, all participants will be given artemether-lumefantrine (AL) to clear any preexisting Pf blood stage infection. This is a randomized, double-blind, placebo-controlled study mainly in WOCBP, weight-stratified (N=270 total), with 2 treatment arms: L9LS 1800 mg SC (n=180) and placebo (n=90) to assess safety and protective efficacy of L9LS. A separate open label male only arm (n=20) will assess sex-differences in the pharmacokinetics (PK) of L9LS at a dose of 1800 mg SC. Male participants will be enrolled during the same time period as the WOCBP arm. Participants will receive the study agent and be followed at visits on study Days 1, 3, 7, 14, 21, and 28 days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments include physical examination, blood collection for identification of Pf infection and other research laboratory evaluations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
279
A human monoclonal antibody to protect against Plasmodium falciparum.
Normal saline
Faladje MRTC Clinic
Faladié, Koulikoro, Mali
Kalifabougou MRTC Clinic
Kalifabougou, Koulikoro, Mali
Torodo MRTC Clinic
Torodo, Koulikoro, Mali
Incidence of local and systemic adverse events (AEs)
Occurring within 7 days after the administration of study agent
Time frame: Days 0, 1, 3, and 7.
Severity of local and systemic adverse events (AEs)
Occurring within 7 days after the administration of study agent
Time frame: Days 0, 1, 3, and 7.
Incidence of laboratory abnormalities
Occurring within 14 days after the administration of study agent
Time frame: Days 7 and 14.
Number of participants with treatment-related laboratory adverse events
Occurring within 14 days after the administration of study agent
Time frame: Days 7 and 14.
Pf blood-stage infection as detected by microscopic examination of thick blood smear
Time frame: Once every 2 weeks post injection through 24 weeks.
Pf blood-stage infection as detected by thick blood smear and RT-PCR
For 24 weeks after administration of study agent.
Time frame: Blood smear once every 2 weeks post injection through 24 weeks.
Concentration of L9LS in sera of recipients.
Time frame: Through 24 weeks.
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