Studying Malaria with P. vivax Challenge Agent

This study is looking at the safety and effectiveness of a special substance called P. vivax challenge agent (derived from PvHMB-CCE001) in healthy adults who have never had malaria. This agent is used to intentionally cause malaria in a controlled way. Researchers want to understand how malaria develops, how the body's immune system reacts, and how it spreads to mosquitoes. You might be able to join if you are a healthy adult between 18 and 54 years old, live near Washington D.C., and have a specific blood factor called Duffy antigen. The main goal is to see if this method of causing malaria is safe. The current status of this study is unclear, and it plans to enroll up to 300 participants.

Study design
This is a single-center, open-label study, meaning both you and the researchers will know what intervention you are receiving. It will involve up to 300 participants.
What's involved
You will be infected with the malaria parasite through an IV. You will likely develop symptoms within a week and will receive antimalarial treatment. You cannot live alone during parts of the study.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the time you receive the challenge agent until at least 21 days after you leave the hospital.

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NCT06607003

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

Recruiting
PHASE1Ages 18–54InterventionalBasic science
National Institute of Allergy and Infectious Diseases (NIAID)
~300 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:P. vivax challenge agent derived from PvHMB-CCE001

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the safety of the P. vivax IBSM model following inoculation of healthy participants.
Measured over Time of inoculation with the challenge agent until at least 21 days after inpatient discharge
Malaria
1 sites across 1 states
Maryland1
  • Joel A Goldberg, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

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  • 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

    Incidence and severity of local and systemic AEs or SAEs.