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NOT YET RECRUITING
NCT07558122
PHASE1

Malaria CVD 36000; Gates INV090205

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

Official title: Phase I, Double-blind, Randomized Study of Physiological Parameters Biosensor Detection Device(s) Diagnosis of P. Falciparum NF54 Strain Malaria Following Controlled Human Malaria Infection and Post-hoc Analysis of Wearable Biosensor Device Detection

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-11

Completion Date

2026-12

Last Updated

2026-09-09

Healthy Volunteers

Yes

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

Locations (1)

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Baltimore, Maryland, United States