Malaria CVD 36000; Gates INV090205

Conditions

• Malaria (Plasmodium Falciparum)

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• PfSPZ Challenge (NF54) — BIOLOGICAL
  PfSPZ Challenge (NF54) administered as a single dose by direct venous inoculation (DVI)
• Wearable Biosensor Devices — DEVICE
  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.
• Placebo — OTHER
  Normal saline placebo

Study Details

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.

Key Dates

Start date

Jun 13, 2026

Status verified

Apr 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: PfSPZ Challenge
  0.5 mL single-dose of PfSPZ Challenge (strain NF54)
• Placebo Comparator: Placebo
  Normale saline placebo

Primary Outcome Measure

Presence of detectable malaria parasitemia following controlled human malaria infection exposure by the Direct Venous Inoculation (DVI) of cryopreserved P. falciparum NF54-strain sporozoites [ Time Frame: From challenge to the end of participation at day 56 ]

Central Contacts

• Kirsten Lyke, MD
  410-706-6156
  [email protected]

Locations (1)

Find similar trials in Baltimore, MD