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Published on: July 17, 2014
A Monoclonal Antibody for Malaria Prevention
Martin R Gaudinski1, Nina M Berkowitz1, Azza H Idris1
1From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
The novel monoclonal antibody CIS43LS demonstrated safety and efficacy in preventing malaria in a phase 1 clinical trial. This long-acting antibody offers a promising new intervention against Plasmodium falciparum infection.
Area of Science:
- Immunology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Malaria remains a significant global health challenge, necessitating novel interventions to reduce morbidity and mortality.
- Existing malaria control strategies require complementary approaches to combat the disease effectively.
Purpose of the Study:
- To evaluate the safety, pharmacokinetics, and efficacy of CIS43LS, an antimalarial monoclonal antibody with an extended half-life.
- To assess the protective potential of CIS43LS against Plasmodium falciparum infection in a controlled human malaria infection model.
Main Methods:
- A two-part, phase 1 clinical trial was conducted in healthy adults.
- Participants received escalating doses of CIS43LS (subcutaneously or intravenously).
- Efficacy was assessed via controlled human malaria infection (CHMI) at various time points post-administration.
Main Results:
- CIS43LS was found to be safe with no identified safety concerns across dose levels.
- A dose-dependent increase in serum concentrations and a half-life of 56 days were observed.
- None of the participants receiving CIS43LS showed parasitemia post-CHMI, compared to 5 of 6 controls, with protection sustained up to 36 weeks at higher doses.
Conclusions:
- The long-acting monoclonal antibody CIS43LS demonstrated efficacy in preventing malaria in adults upon controlled infection.
- CIS43LS represents a potential new tool for malaria prevention, particularly in individuals without prior infection or vaccination.
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