L9LS in Women of Childbearing Potential in Mali

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called L9LS, which is a type of antibody designed to help protect against malaria, a serious illness caused by a parasite. The trial will focus on women who can have children and live in certain areas of Mali. Researchers want to find out if L9LS is safe to use and if it works well to prevent malaria in this group.

To join the study, participants need to be between 18 and 49 years old and in good health. Women who can have children must agree to use reliable birth control before and during the study to prevent pregnancy. Participants will be asked to provide blood samples and share some health information, and they will be closely monitored throughout the trial. People who are pregnant, breastfeeding, or have certain medical conditions won’t be able to join. The study is not yet recruiting participants, but once it begins, it will help researchers understand if L9LS can be a safe and effective way to protect against malaria in women of childbearing age.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Females aged ≥18 and ≤49 years and weighing ≥ 45.0 and ≤ 90.0 kg.
• • 2. Males aged ≥18 and ≤49 years (no weight restrictions).
• • 3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• • 4. In good general health and without clinically significant medical history.
• • 5. Able to provide informed consent.
• • 6. Willing to have blood samples and data stored for future research.
• • 7. Resides in or near Kalifabougou, Faladje, or Torodo, Mali, and available for the duration of the study.
• • 8. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to study Day 0 through the final study visit as described below.
• • 1. Reliable methods of birth control include 1 of the following: confirmed pharmacologic contraceptives via parenteral delivery or intrauterine or implantable device.
• Exclusion Criteria:
• • 1. Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β hCG) test (if female).
• • 2. Currently breastfeeding.
• • 3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol.
• • 4. Study comprehension examination score of \<80% correct or per investigator discretion.
• • 5. Hemoglobin, WBC, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.)
• • 6. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.)
• • 7. Infected with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
• • 8. Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.)
• • 9. Clinically significant abnormal electrocardiogram (ECG; QTc \>460 or other significant abnormal findings, including unexplained tachycardia or bradycardia).
• • 10. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
• • 11. Receipt of any investigational product within the past 30 days.
• • 12. Participation or planned participation in an interventional trial with an investigational product until the last required protocol visit. \[Note: Past, current, or planned participation in observational studies is NOT exclusionary; participation in the placebo arm of the Mali adult CIS43LS MAb trial (ClinicalTrials.gov Identifier: NCT04329104) or the placebo arm of the Mali adult L9LS Mab trial (ClinicalTrials.gov Identifier: NCT05816330) is NOT exclusionary.\]
• • 13. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
• • 14. History of a severe allergic reaction or anaphylaxis.
• • 15. Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years).
• • 16. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.
• • 17. Salivary gland disorder diagnosed by a doctor (e.g., parotitis, sialadenitis, sialolithiasis, salivary gland tumors).
• • 18. Known immunodeficiency syndrome.
• • 19. Known asplenia or functional asplenia.
• • 20. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \>10 mg/day) or immunosuppressive drugs within 30 days of day 0.
• • 21. Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks prior to study agent administration.
• • 22. Receipt of immunoglobulins and/or blood products within the past 6 months.
• • 23. Previous receipt of an investigational malaria vaccine or MAb in the last 5 years.
• • 24. Known allergies or contraindication against artemether lumefantrine.
• • 25. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.