drugset / Trial / NCT04329104
Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali
Phase 2
Completed
348 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard School of Public Health (HSPH) · collabMalaria Research and Training Center, Bamako, Mali · collabUniversity of Washington · collab
RandomizedSequentialDouble-blindPrevention
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of VRC MALMAB0100-00-AB (CIS43LS), a human monoclonal antibody, against naturally occurring Plasmodium falciparum (Pf) infection.
Timeline
- Start
- 2021-02-15
- Primary completion
- 2022-01-26
- Completion
- 2023-07-05
Outcome
Met primary endpoint
paper the efficacy of 40 mg of CIS43LS per kilogram as compared with placebo was 88.2% (adjusted 95% confidence interval [CI], 79.3 to 93.3; P<0.001) PMID 36317783 ↗
paper the efficacy of 10 mg of CIS43LS per kilogram as compared with placebo was 75.0% (adjusted 95% CI, 61.0 to 84.0; P<0.001) PMID 36317783 ↗
Publications
- Results Kayentao K, Ongoiba A, Preston AC, Healy SA, Doumbo S, Doumtabe D, Traore A, Traore H, Djiguiba A, Li S, Peterson ME, Telscher S, Idris AH, Kisalu NK, Carlton K, Serebryannyy L, Narpala S, McDermott AB, Gaudinski M, Traore S, Cisse H, Keita M, Skinner J, Hu Z, Zeguime A, Ouattara A, Doucoure M, Dolo A, Djimde A, Traore B, Seder RA, Crompton PD; Mali Malaria mAb Trial Team. Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali. N Engl J Med. 2022 Nov 17;387(20):1833-1842. doi: 10.1056/NEJMoa2206966. Epub 2022 Oct 31.
- Tran TM, Hu Z, Kayentao K, Ongoiba A, Jones S, Abla N, Healy SA, Cisse H, Chang BH, Skinner J, Serebryannyy L, Narpala SR, Schlesinger R, Low KH, Kazmierski R, Lin BC, Dias J, Doumbo S, Doumtabe D, Preston AC, Li S, Peterson ME, Oberai A, Shandling AD, Campo JJ, Murphy SC, Telscher S, Coates EE, Capparelli EV, Dolo A, Traore B, Seder RA, Crompton PD. Pharmacokinetics and pharmacodynamics of a long-acting monoclonal antibody against malaria in African adults. J Clin Invest. 2026 Jul 2:e207559. doi: 10.1172/JCI207559. Online ahead of print.
- Skinner J, Kayentao K, Ongoiba A, Healy SA, Hu Z, Preston AC, Niangaly A, Schwabl P, Cisse H, Doumbo S, Doumtabe D, Traore A, Li S, Peterson ME, Seilie AM, Chavtur C, Staubus W, Chang M, Kelley K, Traore H, Djiguiba A, Keita M, Ouattara A, Doucoure M, Keita M, Diarra D, Sylla M, Diakite D, Konate M, Traore S, Zeguime A, Dolo A, Neafsey DE, Murphy SC, Traore B, Seder RA, Crompton PD. Anti-sporozoite monoclonal antibody for malaria prevention: secondary efficacy outcome of a phase 2 randomized trial. Nat Med. 2025 Aug;31(8):2682-2690. doi: 10.1038/s41591-025-03739-y. Epub 2025 Jun 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CIS43LS | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | CIS43LS | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | CIS43LS | Monoclonal antibody | 40 mg/kg | Intravenous |