Abbreviated Title: Anti-Malaria Mab in Mali FMPOS Protocol #: 2020/32/CE/FMOS/FAPH Version Date: March 2, 2021
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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: Boubacar Traore, PharmD, PhD (Senior Investigator) MRTC, FMPOS, USTTB Phone: +223 222 8109 Email: [email protected] Role(s): A, B, C, D, E, F Aissata Ongoiba, MD, MPH MRTC, FMPOS, USTTB Phone: +223 222 8109 Email: [email protected] Role(s): A, B, C, D, E, F Safiatou Doumbo, MD, MS MRTC, FMPOS, USTTB Phone: +223 76 03 95 24 Email: [email protected] Role(s): A, B, C, E, F Didier Doumtabe, PharmD, MS MRTC, FMPOS, USTTB Phone: +223 74 44 44 44 Email: [email protected] Role(s): A, B, C, E, F 3 Abbreviated Title: Anti-malaria MAb in Mali Version Date: March 2, 2021 Abdrahamane Traore, MD MRTC, FMPOS, USTTB Phone: +223 76 49 76 58 Email: [email protected] Role(s): A, B, C, E, F US Investigators: NIH investigators are involved in study design, implementation, analysis of coded samples and data, and writing and dissemination of reports of study results. Although they may support Malian investigators in monitoring/oversight capacities, NIH investigators will not be engaged in human subjects research. NIH Principal Investigator and Peter D. Crompton, MD, MPH Referral Contact: LIG, NIAID, NIH 5625 Fishers Lane Room 4N07D Rockville, MD 20852 Phone: 240-383-7640 Email: [email protected] Role(s): F NIH Employee Associate Robert A. Seder, MD (Senior Investigator) Investigators: Chief, Cellular Immunology Section VRC, NIAID, NIH Phone: 301-594-8483 Email: [email protected] Role(s): F Martin Gaudinski, MD Medical Director VRC, NIAID, NIH Phone: 301-761-7094 Email: [email protected] Role(s): F 4 Abbreviated Title: Anti-malaria MAb in Mali Version Date: March 2, 2021 Non-NIH Employee Associate Sara Healy, MD, MPH (Contractor) Investigators: Medical Science & Computing, LLC In support of LIG, NIAID, NIH Phone: 206-550-6493 Email: [email protected] Role(s): F Anne C. Preston, RN, BS, CCRC (Contractor) Gap Solutions, Inc. In support of LIG, NIAID, NIH Phone: 240-669-2876 Email: [email protected] Role(s): F Sean C. Murphy, MD, PhD University of Washington Department of Laboratory Medicine, NW120 Box 357110 1959 Pacific St. Seattle, WA 98195–7110 Phone: 206-685-6162 Email: [email protected] Role(s): F Daniel Neafsey, PhD Harvard T.H. Chan School of Public Health 665 Huntington Avenue Building 1, Room 711 Boston, MA 02115 Phone: 617-432-5404 Email: [email protected] Role(s): F Statistician: Zonghui Hu, PhD Biostatistics Research Branch, NIAID, NIH Phone: 240-669-5240 Email: [email protected] Role(s): F For each person listed above, A. Obtain information by intervening or interacting with identify their roles with the living individuals for research purposes appropriate letter: B. Obtaining identifiable private information about living individuals C. Obtaining the voluntary informed consent of individuals to be subjects 5 Abbreviated Title: Anti-malaria MAb in Mali Version Date: March 2, 2021 D. Makes decisions about subject eligibility E. Studying, interpreting, or analyzing identifiable private information or data/specimens for research purposes F. Studying, interpreting, or analyzing coded (linked) data or specimens for research purposes G. Some/all research activities performed outside NIH Study Sites: Kalifabougou MRTC Clinic Kalifabougou, Mali Région de Koulikoro Préfecture de Kati, Commune de Kalifabougou, Centre de Santé Communautaire de Kalifabougou Torodo MRTC Clinic Torodo, Mali Région de Koulikoro Préfecture de Kati, Commune de Torodo, Centre de Santé Communautaire de Torodo Sponsor Medical Monitor (SMM): Shirley Jankelevich, MD (Contractor) Leidos Biomedical Research, Inc. Support to: OCRPRO, NIAID, NIH Phone: 301-846-7322 Email: [email protected] Independent Safety Monitor (ISM): Daouda K. Minta, MD Point-G Hospital USTTB Phone: +223 7509 0209 Email: [email protected] 6 Abbreviated Title: Anti-malaria MAb in Mali Version Date: March 2, 2021 TABLE OF CONTENTS STATEMENT OF COMPLIANCE .............................................................................................. 11 1 PROTOCOL SUMMARY ..................................................................................................... 12 1.1 Synopsis ......................................................................................................................... 12 1.2 Schema ........................................................................................................................... 15 1.3 Schedule of Activities (SOA) ......................................................................................... 17 1.3.1 Dose-escalation Study ............................................................................................. 17 1.3.2 Efficacy Study ......................................................................................................... 19 2 INTRODUCTION ................................................................................................................. 22 2.1 Study Rationale .............................................................................................................. 22 2.2 Background .................................................................................................................... 22 2.2.1 Overview ................................................................................................................. 22 2.2.2 Study Product: CIS43LS ......................................................................................... 23 2.2.3 Laboratory Assessments of CIS43LS ..................................................................... 27 2.3 Risk/Benefit Assessment ................................................................................................ 28 2.3.1 Known Potential Risks ............................................................................................ 28 2.3.2 Known Potential Benefits ....................................................................................... 30 2.3.3 Assessment of Potential Risks and Benefits ........................................................... 30 3 OBJECTIVES AND ENDPOINTS ....................................................................................... 30 4 STUDY DESIGN .................................................................................................................. 32 4.1 Overall Design ................................................................................................................ 32 4.2 Scientific Rationale for Study Design ............................................................................ 33 4.3 justification for Dose ..................................................................................................... 33 5 STUDY POPULATION ........................................................................................................ 34 5.1 Inclusion Criteria ............................................................................................................ 34 5.2 Exclusion Criteria ........................................................................................................... 34 5.3 Inclusion or Exclusion of Vulnerable Participants ......................................................... 35 5.4 Lifestyle Considerations ................................................................................................. 36 5.5 Screen Failures ............................................................................................................... 36 5.6 Strategies for Recruitment and Retention ...................................................................... 36 5.6.1 Costs ........................................................................................................................ 36 5.6.2 Compensation ......................................................................................................... 36 7 Abbreviated Title: Anti-malaria MAb in Mali Version Date: March 2, 2021 6 STUDY INTERVENTION ................................................................................................... 37 6.1