CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 348 enrolled
Drug / intervention
VRC-MALMAB0100-00-AB (CIS43LS) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04329104
NCT04329104Phase 2Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 1, 2020·Updated Apr 9, 2025

In Brief

A Phase 2 clinical trial evaluating VRC-MALMAB0100-00-AB (CIS43LS) and Normal saline for Plasmodium Falciparum Infection and Malaria. Completed, enrolled 348 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlasmodium Falciparum Infection, Malaria
CountriesMali
CollaboratorsMalaria Research and Training Center, Bamako, Mali, University of Washington, Harvard School of Public Health (HSPH)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 1, 2020
Enrollment StartFeb 15, 2021
Primary CompletionJan 26, 2022
Study CompletionJul 5, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.3 years ago

Interventions

VRC-MALMAB0100-00-AB (CIS43LS)biological

Administered via one-time intravenous infusion

Normal salineother

Administered via one-time intravenous infusion