Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection

November 2, 2026 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Background:

Malaria is a serious disease caused by parasites spread by mosquitoes. To better diagnose and treat malaria, researchers need to learn more about where the parasites go when they enter a person's body. They want to see if they can locate the malaria parasites in the body using imaging scans.

Objective:

To learn whether imaging scans can locate parasites in people with malaria.

Eligibility:

Healthy people aged 18 to 54 years. They must be enrolled in protocol IRB001970 or IRB002627 for controlled malaria infection.

Design:

Participants will be screened. They will have blood drawn and a physical exam, including an abdominal exam to check the size of their spleen.

Participants for this study will have 2 or 3 positron emission tomography/computed tomography (PET/CT) scans: The first will be about 3 days before they are deliberately infected with malaria for a different study. The second will be about 13 days later, while they have the disease. The third scan is optional; it will be done about 3 and 1/2 weeks after the second scan.

For each scan, participants will receive a radioactive tracer called fluorodeoxyglucose (FDG). FDG will be injected through a tube inserted into a vein. They will lie on a table that slides through a doughnut-shaped machine. PET/CT uses x-rays to create images of the inside of the body.

All participants will have a follow-up visit about 3 and 1/2 weeks after the second scan. The blood draw and physical exam will be repeated. This visit may be combined with the third scan for those who choose it.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Description:

Participants who are enrolled in a Plasmodium vivax challenge model protocol at the NIH Clinical Center (CC) may be co-enrolled in this single-site study to undergo a 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET)/computed tomography (CT) scan of their chest, abdomen, and pelvis at baseline before controlled human malaria infection (CHMI) inoculation and again at the expected time of peak parasitemia. FDG uptake will be used to visualize organ-specific changes as a result of malaria infection. Other assessments will include inflammatory labs, signs of bone marrow activation, compete blood count (CBC), reticulocyte counts, and transcriptional analysis.

Objectives:

Primary Objectives:

-To measure changes in spleen standardized uptake value (SUV) from baseline in participants undergoing P. vivax CHMI using PET/CT imaging

Secondary Objectives:

  • Key secondary: To measure changes in organ-specific uptake of FDG from baseline in participants undergoing P. vivax CHMI using PET/CT imaging.
  • Explore the relationship between dyserythropoiesis, hematological abnormalities, and bone marrow/splenic involvement in acute P. vivax malaria.

Exploratory Objectives:

  • To better understand the biomass and sequestration of P. vivax malaria.
  • Improve understanding of timing and location of P. vivax sequestration in tissues.
  • Measure host and parasite factors that lead to organ-specific P. vivax disease.
  • Improve understanding of convalescent changes for expected or unexpected changes in organ size or SUV due to P. vivax after treatment

Endpoints:

Primary Endpoint:

-Percentage change in mean spleen SUV from baseline to post CHMI

Key Secondary Endpoints:

  • Percentage change in max spleen SUV
  • Percentage change in peak spleen SUV
  • Percentage change in spleen volume

Additional Secondary Endpoints:

  • Percentage change in liver volume
  • Percentage change in mean, max, and peak liver SUV
  • Percentage change in mean, max and peak bone marrow SUV
  • CBC with differential, reticulocyte count, and erythropoietin (EPO) at baseline, at the time of the second FDG-PET/CT, and at the end of the CHMI-related activities performed under the co-enrolled study.

Exploratory Endpoints:

  • Describe the relationship between parasitemia/gametocytemia and organ size changes and SUV on FDG-PET/CT with exploratory labs like Plasmodium vivax-specific LDH and others.
  • Other exploratory studies may include but are not limited to proteomic and metabolomic analysis, 10x genomics, and immunophenotyping using flow cytometry or immunohistochemistry (IHC) on peripheral blood mononuclear cells (PBMCs), cytokine levels.
  • Percentage change in organ volume and mean SUV after treatment compared to baseline and compared to the time of peak parasitemia

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Aged >=18 and <=54 years.

  2. Able to provide informed consent.

  3. Co-enrolled in NIH protocol IRB001970, "Phase 1 study of induced blood-stage malaria in healthy malaria-naive adults to assess the safety and infectivity of Plasmodium vivax challenge agent and evaluate transmission in mosquito feeding assays" or IRB002627, "Phase 1/2 study of transmission-blocking vaccine Pvs230D1-EPA/Matrix-M in healthy malaria-naive adults using a Plasmodium vivax controlled human malaria infection model."

  4. Willing to allow long-term storage of study samples for future research.

  5. Individuals of childbearing potential must agree to use an acceptable method of contraception from 1 month prior to the first FDG-PET/CT scan through the end of the study. Participants will also be expected to adhere to the strictest of the contraception

    requirements of any studies they are co-enrolled in. Acceptable methods of contraception include the following:

    • A barrier method (e.g., consistent condom use) combined with an oral contraceptive pill, hormonal patch, or ring.
    • Parenteral hormonal contraceptive implant or an intrauterine device.

    Participants who otherwise are not at risk of becoming pregnant, at the judgement of the investigator will not be required to use contraception. Such participants may include those:

    • Having undergone hysterectomy, bilateral oophorectomy, or bilateral fallopian tube ligation.
    • Having reached menopause (age >=45 years plus no menses for 12 consecutive months without an alternative medical cause).
    • Having exclusive same-sex relations or committed longstanding abstinence due to a serious life choice.
    • Having an exclusive male partner who has undergone vasectomy at least 4 months prior.

  6. Participants need to have established medical care with a primary care doctor or be willing to establish care in case medically relevant findings on their imaging require follow-up.

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Pregnancy or lactation.
  2. History of splenectomy.
  3. History of diabetes or poorly controlled blood sugar, in the judgement of the investigators, would prevent completion of FDG-PET/CT scan.
  4. Currently undergoing therapy with drugs that, in the judgment of the investigators, may interfere with biodistribution of FDG (e.g., insulin that cannot be held or metformin that cannot be stopped for 48 hours prior to each FDG-PET/CT.).
  5. Any other finding that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, or a participant s ability to give informed consent, or increase the risk of having an adverse outcome from

participating in the study.

Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on the LMIV CHMI trials described above and NIH protocol 17I0122, NIAID Centralized Sequencing Protocol. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Volunteers who are co-enrolled in a P. vivax CHMI study

Healthy Volunteers are co-enrolled in a Plasmodium vivax challenge model protocol at the NIH Clinical Center.
Diagnostic test: 18F-fluorodeoxyglucose-positron emission tomography/computed tomography scan

Participants are co-enrolled in a Plasmodium vivax challenge model protocol at the NIH Clinical Center. These participants will undergo up to 3 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET)/computed tomography (CT) scans of their chest, abdomen, and pelvis. PET/CT scans will occur at baseline (before controlled human malaria infection (CHMI) inoculation), and at the expected time of peak parasitemia. Participants may have an optional 3rd PET/CT scan at day 34 after the CHMI inoculation. FDG uptake will be used to visualize organ-specific changes as a result of malaria infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure changes in spleen standardized uptake value (SUV) from baseline in participants undergoing P. vivax CHMI using PET/CT imaging
Time Frame: 34 (+/- 5 days) days post CHMI Inoculation

Percentage change in mean spleen SUV from baseline to post-CHMI
34 (+/- 5 days) days post CHMI Inoculation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure changes in organ specific uptake of FDG from baseline in participants undergoing P. vivax CHMI using PET/CT imaging
Time Frame: 34 (+/- 5 days) days post CHMI Inoculation

Percentage change in max spleen SUV Percentage change in peak spleen SUVPercentage change in spleen volume Percentage change in liver volumePercentage change in liver SUVPercentage change in bone marrow SUV
34 (+/- 5 days) days post CHMI Inoculation
Explore the relationship between dyserythropoiesis, hematological abnormalities, and bone marrow/splenic involvement in acute P. vivax malaria.
Time Frame: 34 (+/- 5 days) days post CHMI Inoculation

CBC with differential, reticulocyte count, and erythropoietin (EPO) at baseline, at the time of the second FDG-PET/CT, and at the end of the CHMI-related activities performed under the co-enrolled study.
34 (+/- 5 days) days post CHMI Inoculation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Shanan R Immel, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 8, 2026

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

October 3, 2026

First Submitted That Met QC Criteria

October 5, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

October 8, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10002660
  • 002660-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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