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Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali

NCT04329104 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2025-04-09

Study results available
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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.

Conditions

  • Plasmodium Falciparum Infection
  • Malaria

Interventions

BIOLOGICAL

VRC-MALMAB0100-00-AB (CIS43LS)

Administered via one-time intravenous infusion

OTHER

Normal saline

Administered via one-time intravenous infusion

Sponsors & Collaborators

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kassoum Kayentao, MD, MPH, PhD · Faculté de Médecine Pharmacie d'Odontostomatologie (FMPOS)

  • Peter D. Crompton, MD, MPH · National Institutes of Health (NIH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2022-01-26
Completion
2023-07-05
FDA Drug
Yes

Countries

  • Mali

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329104 on ClinicalTrials.gov