Abbreviated Title: Anti-malaria MAb in Mali FMPOS Protocol #: 2020/32/CE/FMOS/FAPH Version Date: March 2, 2021 Title: Safety and Efficacy of VRC-MALMAB0100-00-AB (CIS43LS), a Human Monoclonal Antibody against Plasmodium falciparum, in a Dose-Escalation Trial and a Randomized, Double-Blind Trial of Adults in Mali FMPOS Principal Investigator: Kassoum Kayentao, MD, MPH, PhD Malaria Research and Training Center (MRTC) Faculté de Médecine Pharmacie d’Odontostomatologie (FMPOS) University of Sciences, Techniques, & Technologies of Bamako (USTTB) NIH Principal Investigator: Peter D. Crompton, MD, MPH Laboratory of Immunogenetics (LIG) National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Investigational Agent: Drug Name VRC-MALMAB0100-00-AB (CIS43LS) Investigational New 147485 Drug (IND) Number Sponsor Office of Clinical Research Policy and Regulatory Operations (OCRPRO), Division of Clinical Research, NIAID Manufacturer Vaccine Research Center (VRC), NIAID Data and Safety Monitoring Board (DSMB): NIAID Intramural DSMB 2 Abbreviated Title: Anti-malaria MAb in Mali Version Date: March 2, 2021 STUDY STAFF ROSTER FMPOS Investigators: The research activities of the following FMPOS investigators will be reviewed by: FMPOS Ethics Committee BP E302, Point G/FMPOS Bamako, Mali FWA #00001769 FMPOS Principal Investigator: Kassoum Kayentao, MD, MPH, PhD MRTC, FMPOS, USTTB BP E302, Point G/FMPOS Bamako, Mali Phone: +223 7646 0173 Email:
[email protected] Role(s): A, B, C, D, E, F FMPOS Associate Investigators: