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Malaria CVD 36000; Gates INV090205

NCT07558122 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-30

No results posted yet for this study

Summary

In order to control infections, the investigators must first detect them. Biosensor devices may allow early detection and intervention for infectious diseases, helping the investigators to recognize infections early, and allow for early treatment. This will lower transmission of infections and lower costs for treating someone who becomes ill. This is a study testing whether a wearable device such as a wristband and/or earphones can measure early biologic signals to detect identify infection in prior to seeing symptoms related of a disease. As a first test of this technology, the investigators will expose participants to injectable malaria or placebo. This is called a "Controlled Human Malaria Infection" (CHMI). Everyone who takes part in the CHMI may get malaria infection. The investigators will detect malaria using standard blood tests. The investigators will also look for early symptoms of malaria infection like changes in temperature, heart rate, breathing, sleep patterns, and changes in skin and muscle activity or voice. These signals may allow the investigators to detect early malaria infection. This is a study testing whether a wearable device such as a wristband and/or earphones can measure early biologic signals to detect malaria infection before symptoms occur, as confirmed by standard blood testing.

Conditions

  • Malaria (Plasmodium Falciparum)

Interventions

BIOLOGICAL

PfSPZ Challenge (NF54)

PfSPZ Challenge (NF54) administered as a single dose by direct venous inoculation (DVI)

DEVICE

Wearable Biosensor Devices

Investigational, wearable biosensing devices. The objective would be to collect biosensor data for correlation to known malaria infection by reference diagnostic testing and with physiological (clinical) data.

OTHER

Placebo

Normal saline placebo

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Sanaria Inc.

    collaborator INDUSTRY

  • University of Texas at Austin

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-06-13
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07558122 on ClinicalTrials.gov