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

• 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.