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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 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.

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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.

Conditions Studied

Interventions

  • BIOLOGICAL HMPBS02-Pv

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2022-02-15
Est. Completion 2022-09-15
Phase Phase 1

What the Registry Record Tells You About NCT05095272

The ClinicalTrials.gov registry entry for NCT05095272 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 258-participant average among 27 other Malaria trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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