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
University of Maryland, Baltimore
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.
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Male or non-pregnant, non-breastfeeding female between 18 and 50 years of age (inclusive) at the time of consent. 2. Participants must be able to provide written informed consent. 3. Participants must be healthy as established by medical history and clinical examination at study entry. 4. Participants must pass a comprehension (defined as 80%) test and be able to comply with all study requirements. 5. Both males and females are eligible to participate as per the following: Participants physically capable of pregnancy must agree to use effective contraception to avoid p…
Interventions
- BiologicalPfSPZ Challenge (NF54)
PfSPZ Challenge (NF54) administered as a single dose by direct venous inoculation (DVI)
- DeviceWearable 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.
- OtherPlacebo
Normal saline placebo
Location
- University of Maryland, Baltimore, Center for Vaccine Development and Global HealthBaltimore, Maryland