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NCT00744133 · ClinicalTrials.gov registry record · Phase 1

Malaria Challenge With NF54 Strain

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
37
Enrollment target

NCT00744133 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 37 participants.

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The verdict

NCT00744133, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
37 participants
Enrollment target

Study Summary

The purpose of this study is to determine how many infected mosquito bites are required to reliably give volunteers a case of malaria. It is expected that volunteers will develop malaria and may have symptoms. Safety is the main concern. A malaria challenge is given by allowing a volunteer to receive 1, 3, or 5 mosquito's bites. Then participants are carefully followed and blood is tested. The study will also look at how immune systems (the cells and substances that protect the body from infection and foreign matter) respond after mosquito bite challenges. About 38 subjects (aged 18-40 years) from the greater Baltimore, Maryland (United States) community will participate and may stay overnight for 10 days at a local medical center. Procedures include medical screening, assignment to a dose group, a mosquito bite challenge, and 56 day follow-up. Volunteers will be contacted by telephone at 6 and 12 months after the malaria challenge.

Interventions

  • BIOLOGICAL NF54 P. falciparum isolate

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2009-03
Est. Completion 2011-11
Phase Phase 1

What the Registry Record Tells You About NCT00744133

The ClinicalTrials.gov registry entry for NCT00744133 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which NF54 P. falciparum isolate is the first listed.

NCT00744133 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00744133 about?

NCT00744133 is a clinical study titled "Malaria Challenge With NF54 Strain". The purpose of this study is to determine how many infected mosquito bites are required to reliably give volunteers a case of malaria. It is expected that volunteers will develop malaria and may have symptoms. Safety is the main concern. A malaria challenge is given by allowing a volunteer to receiv...

What is the current status of trial NCT00744133?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2009-03. Estimated completion is 2011-11.

What interventions are being tested in trial NCT00744133?

The interventions under investigation include: NF54 P. falciparum isolate (BIOLOGICAL).

Who is sponsoring clinical trial NCT00744133?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.