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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
32
PfSPZ Challenge (NF54) administered as a single dose by direct venous inoculation (DVI)
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.
Normal saline placebo
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States
Presence of detectable malaria parasitemia following controlled human malaria infection exposure by the Direct Venous Inoculation (DVI) of cryopreserved P. falciparum NF54-strain sporozoites
Presence or absence of RT-qPCR through Day 28 (unit - Ct value)
Time frame: From challenge to the end of participation at day 56
Presence of detectable malaria parasitemia following controlled human malaria infection exposure by the Direct Venous Inoculation (DVI) of cryopreserved P. falciparum NF54-strain sporozoites
Presence of absence of Thick Blood Smear - unit - parasite/mm3 or mL
Time frame: From challenge to the end of participation at day 56
Time of detectable malaria parasitemia following controlled human malaria infection exposure by the Direct Venous Inoculation (DVI) of cryopreserved P. falciparum NF54-strain sporozoites
Time to Pf infection (unit - days)
Time frame: From challenge to the end of participation at day 56
Presence or absence of temperature associated with pre-infection, asymptomatic parasitemia and symptomatic parasitemia
Time frame: From challenge to the end of participation at day 56
Presence or absence of heart Rate changes associated with pre-infection, asymptomatic parasitemia and symptomatic parasitemia
Time frame: From challenge to the end of participation at day 56
Presence or absence of Respiratory Rate associated with pre-infection, asymptomatic parasitemia and symptomatic parasitemia
Time frame: From challenge to the end of participation at day 56
Presence or absence of Solicited Systemic Symptoms associated with pre-infection, asymptomatic parasitemia and symptomatic parasitemia
(yes/no to headache, fatigue/malaise, myalgia, arthralgia, nausea, abdominal pain, vomiting)
Time frame: From challenge to the end of participation at day 56
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