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NCT01546389 · ClinicalTrials.gov registry record · Phase 1

Sanaria™ PfSPZ Challenge Vaccine

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

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT01546389 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 30 participants, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01546389, 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
30 participants
Enrollment target
1
Study location

Study Summary

This study will randomize 30 healthy adult participants to one of three cohorts comprised of six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID route. The goal will be to determine the optimal dose required to achieve 100% infectivity (ID100) of adult volunteers with P. falciparum malaria.

Conditions Studied

Interventions

  • BIOLOGICAL Sanaria™ PfSPZ Vaccine
  • DRUG Chloroquine

Study Locations (1)

Maryland

  • University of Maryland School of Medicine - Center for Vaccine Development - Baltimore - Baltimore

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-04
Est. Completion 2013-04
Phase Phase 1

What the Registry Record Tells You About NCT01546389

The ClinicalTrials.gov registry entry for NCT01546389 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (88% 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 2 interventions - of which Sanaria™ PfSPZ Vaccine is the first listed.

NCT01546389 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01546389 about?

NCT01546389 is a clinical study titled "Sanaria™ PfSPZ Challenge Vaccine". This study will randomize 30 healthy adult participants to one of three cohorts comprised of six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID route. The goal will be to determine the optimal dose required to achieve 100% infectivity (ID100) of adult voluntee...

What is the current status of trial NCT01546389?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-04. Estimated completion is 2013-04.

What conditions does trial NCT01546389 study?

This clinical trial studies the following conditions: Malaria.

What interventions are being tested in trial NCT01546389?

The interventions under investigation include: Sanaria™ PfSPZ Vaccine (BIOLOGICAL), Chloroquine (DRUG).

Who is sponsoring clinical trial NCT01546389?

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 NCT01546389 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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