Malaria CVD 36000; Gates INV090205

NCT07558122 | Not Yet Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: HP-00118316
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria (Plasmodium Falciparum)

Outcome Measures

Primary Outcomes (7)

• 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)

  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

  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)

  From challenge to the end of participation at day 56

• Presence or absence of temperature associated with pre-infection, asymptomatic parasitemia and symptomatic parasitemia

  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

  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

  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)

  From challenge to the end of participation at day 56

Study Arms (2)

PfSPZ Challenge

EXPERIMENTAL

0.5 mL single-dose of PfSPZ Challenge (strain NF54)

Biological: PfSPZ Challenge (NF54); Device: Wearable Biosensor Devices

Placebo

PLACEBO COMPARATOR

Normale saline placebo

Device: Wearable Biosensor Devices; Other: Placebo

Interventions

PfSPZ Challenge (NF54) BIOLOGICAL

PfSPZ Challenge (NF54) administered as a single dose by direct venous inoculation (DVI)

PfSPZ Challenge

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.

PfSPZ Challenge; Placebo

Placebo OTHER

Normal saline placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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 pregnancy from 28 days before enrollment through 10 months after last administration of investigational product are eligible to participate. An effective contraceptive method is defined as one that results in a failure rate of less than 1% per year when it is used consistently and correctly. Adequate contraceptive precautions include intrauterine contraceptive device, oral contraceptives, diaphragm, or condom in combination with contraceptive jelly, cream, or foam; Norplant® or Depo-Provera®, through the completion of study visits to minimize any potential risk.
• i. Effective contraception does not apply to participants of child-bearing potential with same sex partners, when this is their preferred and usual lifestyle.
• ii. Adequate contraception does not apply to women with documented surgical sterility (tubal ligation, bilateral oophorectomy, salpingectomy, or hysterectomy), congenital sterility, who have a diagnosis of infertility and are not undergoing treatment, or women who have not had a menstrual period in at least 1 year

You may not qualify if:

• 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).
• Note: Prior participants of HIV vaccine studies may result in a false positive HIV antibody test, as such, in this scenario, participant will be eligible if they have a negative HIV RNA PCR at screening.
• Safety laboratory test results within range at screening (as per FDA Toxicity Grading Scale, see Appendix A):
• White Blood Cell (WBC) 3,500-12,000/mm3
• WBC differential either within institutional normal range or accompanied by the PI or designee approval
• Platelets = 125,000 - 500,000/mm3
• Hemoglobin within institutional normal range or accompanied by the PI or designee approval
• Creatinine ≤ 1.1 x upper limit of normal (ULN)
• ALT ≤1.25 x ULN
• A 5-year cardiovascular risk of \>10% using the Gaziano nomogram (Appendix B)
• Significant screening physical examination abnormalities at the discretion of the investigator, including a BMI \> 35 kg/m2
• Electrocardiogram (ECG) with clinically significant abnormalities (examples may include: pathologic Q waves, significant ST-T wave changes, left ventricular hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions, right or left bundle branch block, advanced A-V heart block). ECG abnormalities determined by an investigator to be clinically insignificant as related to trial participation do not preclude trial enrollment. Consultation may be sought by a cardiologist at investigator discretion.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Bill and Melinda Gates Foundation: collaborator
• Sanaria Inc.: collaborator
• University of Texas at Austin: collaborator

Study Sites (1)

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Central Study Contacts

Kirsten Lyke, MD

CONTACT

410-706-6156; klyke@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Medicine

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): June 13, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)