Malaria CVD 36000; Gates INV090205

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Maryland, Baltimore

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PfSPZ Challenge (NF54)

    Biological/Vaccine

    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 intervention

    Normal saline placebo

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: PfSPZ ChallengeExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Bill and Melinda Gates Foundation

Collaborator

Sanaria Inc.

Collaborator

University of Texas at Austin

Collaborator

This trial is not recruiting at the moment. You can still explore other options: