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NCT05095272 · ClinicalTrials.gov registry record · Phase 1
Blood-Stage Plasmodium Vivax Cell Bank
A Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT05095272: Completed Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05095272 is a Phase 1 study of Malaria that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2 participants, below the 258-participant average among 27 other Malaria trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05095272, a Phase 1 study of Malaria, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Malaria is caused by a parasite (a type of germ called P. vivax) that is carried by mosquitoes. The disease is transmitted to people when they are bitten by infected mosquitoes. To make drugs and vaccines for malaria, researchers need malaria-infected blood. Plasmodium vivax cell cultures are currently not cultured in vivo, and thus establishing a blood bank from P. vivax infections will be vital for future research. Objective: The goal of this study is to infect people with early-stage malaria, then collect infected blood samples to store in a cell bank for future use. Eligibility: Healthy adults ages 18-50 who will not be living alone during the study period. Design: Participants will be screened with a physical exam, heart health test, and medical history. They will have blood and urine tests. They will take a mental health survey. They must pass an exam to prove they understand the study. Participants will have red blood cells infected with P. vivax injected into an arm vein. They will be observed for side effects. They will get a thermometer to measure their temperature at home. For the next 3 days, they will be monitored via phone call or text. Starting on day 4 after the infection, they will have daily study visits to give blood samples. They will likely develop symptoms of malaria, such as fever, chills, headache, and muscle pain. Participants will be admitted to the hospital for 2-3 days when either they develop symptoms or the daily blood tests detect a certain amount of parasites. Once malaria is confirmed, a sample of their blood will be collected for the cell bank. Then they will be treated for malaria with oral medication that will cure the infection. Those who do not develop malaria will begin treatment after 15 days. Participants will have follow-up visits 28 and 90 days after infection. Participation will last for 3-5 months.
Primary Outcome
Collection of blood for the production of a P. vivax blood-stage parasite bank from study participants following experimental infection with P. vivax isolate HMPBS02-Pv.
Conditions Studied
Interventions
- BIOLOGICAL HMPBS02-Pv
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2022-09-15 |
| Phase | Phase 1 |
What the finished NCT05095272 record still lists
NCT05095272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 258-participant average among 27 other Malaria trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 1 intervention - of which HMPBS02-Pv is the first listed.
NCT05095272 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05095272 about?
NCT05095272 is a clinical study titled "Blood-Stage Plasmodium Vivax Cell Bank". Background: Malaria is caused by a parasite (a type of germ called P. vivax) that is carried by mosquitoes. The disease is transmitted to people when they are bitten by infected mosquitoes. To make drugs and vaccines for malaria, researchers need malaria-infected blood. Plasmodium vivax cell cultur...
What is the current status of trial NCT05095272?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2022-02-15. Estimated completion is 2022-09-15.
What conditions does trial NCT05095272 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT05095272?
The interventions under investigation include: HMPBS02-Pv (BIOLOGICAL).
Who is sponsoring clinical trial NCT05095272?
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 NCT05095272 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
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Where NCT05095272's enrollment target sits among peer trials
2 28th of 27 the lowest 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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