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P. vivax challenge agent derived from PvHMB-CCE001 / Malaria · Phase 1 Trial
ClinicalTrials.gov · August 3, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registry record (not yet reporting results) designed to evaluate the safety profile and infectivity of a P. vivax blood-stage challenge agent in healthy malaria-naive adults, and to assess transmission potential via mosquito feeding. No efficacy or outcome data are available from this registry entry.
Phase 1, Interventional, Non Randomized, Single Group, Open label, Basic Science purpose. Malaria; age from 18 Years; to 54 Years; accepts healthy volunteers. Intervention: P. vivax challenge agent derived from PvHMB-CCE001 Main Arm; P. vivax challenge agent derived from PvHMB-CCE001 Pilot Arm. n = 300. 1 site: United States.
This is a Phase 1 trial registry record (not yet reporting results) designed to evaluate the safety profile and infectivity of a P. vivax blood-stage challenge agent in healthy malaria-naive adults, and to assess transmission potential via mosquito feeding. No efficacy or outcome data are available from this registry entry.
Follow-up duration reported only as 3 weeks post-discharge; long-term safety data not available from this record.
This registry record describes a planned Phase 1 safety and transmission study; no clinical outcomes or efficacy data are reported and cannot inform treatment or prevention decisions at this stage.
This is a Phase 1 clinical trial registry record with no results posted; it describes a planned study to assess safety and infectivity of a P. vivax challenge agent in healthy adults.
As stated by the source record.
Quoted from the source exactly as published.
This registry record describes a planned Phase 1 safety and transmission study; no clinical outcomes or efficacy data are reported and cannot inform treatment or prevention decisions at this stage.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06607003). This is a study registration, not published results. Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Malaria. Interventions: BIOLOGICAL: P. vivax challenge agent derived from PvHMB-CCE001. Primary outcome measures: To assess the safety of the P. vivax IBSM model following inoculation of healthy participants. , Time of inoculation with the challenge agent until at least 21 days after inpatient discharge. Brief summary: Background: Malaria is a disease caused by parasites transmitted to people by mosquitoes. Around the world, there were 241 million cases and 627,000 deaths from malaria in 2020. Researchers are working to develop vaccines and treatments for this disease. Objective: To learn how malaria develops in people; how the body's immune system reacts to malaria; and how malaria spreads from people to mosquitoes. Eligibility: Healthy people in the Washington DC area, aged 18 to 54 years. They cannot live alone during parts of the study. Design: Participants will be infected with a parasite that causes malaria. The parasite will be in donated blood; it will be given through an IV. Participants will likely develop symptoms within a week after the injection. Researchers will call daily to check on their health. After about 6 days, participants will come to the NIH clinic each day for blood tests. Participants will check in to the NIH clinic around 10 days after the injection. They will stay in the clinic 3 to 6 days. They will have multiple blood tests every day. Participants will be bitten by mosquitoes up to 4 times. Cups containing mosquitoes will be held against their skin for 15 minutes. Participants will begin taking chloroquine close to the end of their clinic stay. Chloroquine is a pill taken by mouth once or twice a day for 3 days. It is FDA-approved to treat malaria. Participants will have follow-up visits 1 and 3 weeks after discharge.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.