drugset / Trial / NCT05816330
L9LS MAb in Malian Adults
Phase 2
Completed
490 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard School of Public Health (HSPH) · collabIndiana University · collabMalaria Research and Training Center, Bamako, Mali · collabNational Institutes of Health (NIH) · collabUniversity of Washington · collabUniversity of the Sciences, Techniques and Technologies of Bamako · collab
RandomizedSequentialTriple-blindPrevention
Summary
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. A secondary objective is to determine if SC administration of L9LS at 900 mg (compared to placebo) mediates protection against naturally occurring Pf infection in healthy Malian adult females stratified by weight during a single malaria season.
Timeline
- Start
- 2023-05-25
- Primary completion
- 2024-02-11
- Completion
- 2024-02-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | L9LS | Monoclonal antibody | 900 mg | Subcutaneous |