Actively Recruiting
L9LS in Women of Childbearing Potential in Mali
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-02-17
290
Participants Needed
3
Research Sites
36 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
L9LS in Women of Childbearing Potential in Mali
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females aged 18 to 49 years weighing between 45.0 and 90.0 kg
- Males aged 18 to 49 years (no weight restrictions)
- Able to provide proof of identity acceptable to the study clinician
- In good general health without significant medical history
- Able to provide informed consent
- Willing to have blood samples and data stored for future research
- Reside in or near Kalifabougou, Faladje, or Torodo, Mali, and available for study duration
- Females of childbearing potential willing to use reliable contraception from 21 days before Day 0 through final study visit
- Reliable contraception includes pharmacologic contraceptives by parenteral delivery or intrauterine or implantable device
You will not qualify if you...
- Pregnancy determined by positive urine or serum beta-human choriogonadotropin test (if female)
- Currently breastfeeding
- Behavioral, cognitive, or psychiatric conditions affecting study understanding or compliance
- Study comprehension score below 80% or per investigator discretion
- Hemoglobin, white blood cell, neutrophil, or platelet counts outside normal limits unless deemed not clinically significant
- Elevated alanine transaminase or creatinine levels above normal limits unless deemed not clinically significant
- Infection with HIV, hepatitis B, or hepatitis C virus
- Known or documented sickle cell disease (sickle cell trait allowed)
- Clinically significant abnormal electrocardiogram findings
- Significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematologic, oncologic, or renal disease
- Receipt of investigational product within past 30 days
- Participation or planned participation in interventional trials with investigational products until last required visit
- Alcohol or illicit drug problems in past 12 months
- History of severe allergic reactions or anaphylaxis
- Severe asthma requiring urgent care or corticosteroids in past 2 years
- Pre-existing autoimmune or antibody-mediated diseases
- Diagnosed salivary gland disorders
- Known immunodeficiency syndrome
- Known asplenia or functional asplenia
- Use of chronic oral or IV corticosteroids at immunosuppressive doses or immunosuppressive drugs within 30 days before Day 0
- Receipt of live vaccine within 4 weeks or killed vaccine within 2 weeks prior to study agent
- Receipt of immunoglobulins or blood products within past 6 months
- Previous investigational malaria vaccine or monoclonal antibody in last 5 years
- Known allergies or contraindications to artemether lumefantrine
- Any other condition that could jeopardize safety, interfere with study objectives, or limit compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Faladje MRTC Clinic
Faladié, Koulikoro, Mali
Actively Recruiting
2
Kalifabougou MRTC Clinic
Kalifabougou, Koulikoro, Mali
Actively Recruiting
3
Torodo MRTC Clinic
Torodo, Koulikoro, Mali
Actively Recruiting
Research Team
K
Kassoum Kayentao, MD, MPH, PhD
CONTACT
B
Boubacar Traore, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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