About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Male or non-pregnant, non-breastfeeding female between 18 and 50 years of age (inclusive) at the time of consent.
Participants must be able to provide written informed consent.
Participants must be healthy as established by medical history and clinical examination at study entry.
Participants must pass a comprehension (defined as 80%) test and be able to comply with all study requirements.
Disqualifiers
Women who are pregnant or breastfeeding
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
History of malaria infection, or history > 6 months spent in a malaria endemic region within 5 years prior to enrollment.
Participant seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV).
Trial design
Parallel
Treatments tested in this trial
PfSPZ Challenge (NF54)
Biological/VaccinePfSPZ Challenge (NF54) administered as a single dose by direct venous inoculation (DVI)
Wearable Biosensor Devices
DeviceInvestigational, 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.
Placebo
Other interventionNormal saline placebo
Treatment groups
Trial outcomes
Primary outcomes
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)
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 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)
Presence or absence of temperature associated with pre-infection, asymptomatic parasitemia and symptomatic parasitemia
Sponsors and contacts
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University of Maryland, Baltimore
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
Sanaria Inc.
Collaborator
University of Texas at Austin
Collaborator
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