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Clinical Research and Public HealthIn-Press PreviewClinical ResearchImmunologyInfectious disease Open Access | 10.1172/JCI207559

Pharmacokinetics and pharmacodynamics of a long-acting monoclonal antibody against malaria in African adults

Tuan M. Tran,1 Zonghui Hu,2 Kassoum Kayentao,3 Aissata Ongoiba,4 Sam Jones,5 Nada Abla,5 Sara A. Healy,6 Hamidou Cisse,6 Bickey H. Chang,6 Jeff Skinner,6 Leonid Serebryannyy,7 Sandeep R. Narpala,7 Robin Schlesinger,7 Kwang Huei Low,7 Rachel Kazmierski,7 Bob C. Lin,7 Joana Dias,7 Safiatou Doumbo,9 Didier Doumtabe,9 Anne C. Preston,6 Shanping Li,6 Mary E. Peterson,6 Amit Oberai,10 Adam D. Shandling,10 Joseph J. Campo,10 Sean C Murphy,11 Shinyi Telscher,7 Emily E. Coates,7 Edmund V. Capparelli,12 Amagana Dolo,4 Boubacar Traore,4 Robert A. Seder,7 and Peter D. Crompton6

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Tran, T. in: PubMed | Google Scholar |

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Hu, Z. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Kayentao, K. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Ongoiba, A. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Jones, S. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Abla, N. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Healy, S. in: PubMed | Google Scholar |

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Cisse, H. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Chang, B. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Skinner, J. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Serebryannyy, L. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Narpala, S. in: PubMed | Google Scholar |

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Schlesinger, R. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Low, K. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Kazmierski, R. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Lin, B. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Dias, J. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Doumbo, S. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Doumtabe, D. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Preston, A. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Li, S. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Peterson, M. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Oberai, A. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Shandling, A. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Campo, J. in: PubMed | Google Scholar |

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

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1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

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1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

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1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

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1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

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1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

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1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

Find articles by Seder, R. in: PubMed | Google Scholar

1Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, United States of America

2Office of Biostatistics Research, National Institutes of Health, Bethesda, United States of America

3Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

4Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

5MMV Medicines for Malaria Venture, Geneva, Switzerland

6Division of Intramural Research, National Institutes of Health, Bethesda, United States of America

7Vaccine Research Center, National Institutes of Health, Bethesda, United States of America

8Vaccine Research Center, National Institutes of Health, Bethesda, Sweden

94Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali

10Antigen Discovery, Irvine, United States of America

11Department of Laboratory Medicine and Pathology and Center for Emerging and, University of Washington, Seattle, United States of America

12Departments of Pediatrics and Pharmacy, UC San Diego Schools of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, United States of America

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Published July 6, 2026 - More info

J Clin Invest. https://doi.org/10.1172/JCI207559.
Copyright © 2026, Tran et al. This work is licensed under the Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
Published July 6, 2026 - Version history
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Abstract

Background. CIS43LS is a long-acting mAb that targets the Plasmodium falciparum circumsporozoite protein. A phase 2 trial showed that a single dose of CIS43LS conferred >85% sterile protection against infection in Malian adults over 6 months. Understanding the pharmacokinetics and pharmacodynamics (PK/PD) of CIS43LS is critical for the further development of CIS43LS and other anti-malaria mAbs. Methods. Using 3,777 serum samples collected from 348 trial participants over the 6-month study period, we performed a PK/PD analysis of CIS43LS that included assessments for anti-drug antibodies and target-mediated drug disposition. A two-compartment, non-linear mixed effects population PK model that evaluated demographic, anthropometric, hematologic, baseline parasitemia, and endogenous IgG and IgG1 as potential covariates was used to estimate PK parameters and serum concentrations required to achieve 80% efficacy. Results. The median CIS43LS t1/2 was 63.2 days (95%CI 59.4–67.2 days). Serum concentrations ≥64 μg/mL (95%CI 49–93 μg/mL) corresponded to ≥80% efficacy against infection over 6 months. A simulated dose of 30 mg/kg maintained serum concentrations >64 µg/mL in >97.5% of individuals for 4 months, the timeframe for the World Health Organization preferred product characteristics for anti-malaria mAbs. There was no evidence of anti-drug antibodies. Among infected individuals who received CIS43LS, no marked evidence of target-mediated drug disposition was observed. Conclusion. This study indicates that protective CIS43LS levels can be maintained over the course of a single malaria season and provides guidance for PK/PD analyses of anti-malaria mAbs in malaria-endemic populations. Trial registration. NCT04329104. Funding. National Institutes of Health and Gates Foundation.

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