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NCT00392015 · ClinicalTrials.gov registry record · Phase 1
NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1
A Phase 1 study of Plasmodium Falciparum, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT00392015: Completed Phase 1 study of Plasmodium Falciparum, sponsored by U.S. Army Medical Research and Development Command.
NCT00392015 is a Phase 1 study of Plasmodium Falciparum that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00392015, a Phase 1 study of Plasmodium Falciparum, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether a new investigational malaria vaccine is safe, well tolerated and effective against experimental exposure to malaria when given to healthy people with no previous exposure to malaria. The vaccine consists of a modified form of a relatively common virus, adenovirus, that has been rendered incapable of replicating itself and modified to deliver the malaria gene of interest to the body's cells allowing the cell to manufacture the protein encoded by the gene and present it to the body's immune system in a more natural and presumably effective way.
Primary Outcome
To assess the safety and tolerability of NMRC-M3V-Ad-PfCA, in a dose-escalation design (Part A), in healthy malaria-naïve adults. Part A was a dose escalation of NMRC-M3V-AdPfCA (2 antigen combination) using two dose groups, 2x10\^10 pu (Group 1) and 1x10\^11 pu (Group 2). Subjects received a single intramuscular injection with the injections in the 2 groups staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B. The vaccine wa
Conditions Studied
Interventions
- BIOLOGICAL NMRC-M3V-Ad-PfCA
- BIOLOGICAL NMRC-MV-Ad-PfC, NMRC-M3V-Ad-PfCA
Study Locations (1)
Maryland
- Naval Medical Research Center (NMRC) Clinical Trials Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2006-10-12 |
| Est. Completion | 2017-09-25 |
| Phase | Phase 1 |
What the finished NCT00392015 record still lists
NCT00392015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Plasmodium Falciparum appearing as the primary indexed condition, and to 2 interventions - of which NMRC-M3V-Ad-PfCA is the first listed.
NCT00392015 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00392015 about?
NCT00392015 is a clinical study titled "NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1". The purpose of this study is to determine whether a new investigational malaria vaccine is safe, well tolerated and effective against experimental exposure to malaria when given to healthy people with no previous exposure to malaria. The vaccine consists of a modified form of a relatively common vir...
What is the current status of trial NCT00392015?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2006-10-12. Estimated completion is 2017-09-25.
What conditions does trial NCT00392015 study?
This clinical trial studies the following conditions: Plasmodium Falciparum.
What interventions are being tested in trial NCT00392015?
The interventions under investigation include: NMRC-M3V-Ad-PfCA (BIOLOGICAL), NMRC-MV-Ad-PfC, NMRC-M3V-Ad-PfCA (BIOLOGICAL).
Who is sponsoring clinical trial NCT00392015?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00392015 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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Where NCT00392015's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 of 2,000 other Phase 1 trials
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