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

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

No aplica

Rango de edad

18 años - 54 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

45 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

• 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.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No aplica

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Equipo y fechas

Patrocinador principal

National Institute of Allergy and Infectious Diseases (NIAID)

Inicio del estudio

15 nov 2026 Estimado

Finalización primaria

1 nov 2030 Estimado

Finalización del estudio

1 nov 2030 Estimado

Primera publicación

6 oct 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio