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NCT06607003 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT06607003: Recruiting Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06607003 is a Phase 1 study of Malaria that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 300 participants, above the 247-participant average among 27 other Malaria trials with a reported enrollment target (21% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06607003, a Phase 1 study of Malaria, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Incidence and severity of local and systemic AEs or SAEs.
Conditions Studied
Interventions
- BIOLOGICAL P. vivax challenge agent derived from PvHMB-CCE001
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-11-26 |
| Est. Completion | 2027-11-26 |
| Phase | Phase 1 |
What NCT06607003 shows while recruiting
NCT06607003 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 247-participant average among 27 other Malaria trials with a reported enrollment target (21% higher).
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 1 intervention - of which P. vivax challenge agent derived from PvHMB-CCE001 is the first listed.
NCT06607003 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06607003 about?
NCT06607003 is a clinical study titled "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". 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 i...
What is the current status of trial NCT06607003?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2024-11-26. Estimated completion is 2027-11-26.
What conditions does trial NCT06607003 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT06607003?
The interventions under investigation include: P. vivax challenge agent derived from PvHMB-CCE001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06607003?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06607003 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06607003's enrollment target sits among peer trials
300 5th of 27 higher than 22 of 27 other Malaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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