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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: Completed Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01546389 record still lists
NCT01546389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
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 NCT01546389's enrollment target sits among peer trials
30 22nd of 27 higher than 5 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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