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NCT01540474 · ClinicalTrials.gov registry record · Phase 1
Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults
A Phase 1 study of Malaria, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01540474 is a Phase 1 study of Malaria that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 36 participants, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01540474, a Phase 1 study of Malaria, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for protecting troops against malaria are insecticidal nets, clothing, and antimalarial treatment. To be effective, these methods must be self-administered and be used consistently, often unattainable in field or combat situations. The United States Army Medical Research and Development Command (USAMRMC), through the United States Army Medical Materiel Development Activity (USAMMDA) and the Walter Reed Army Institute of Research (WRAIR) are actively pursuing the development of an effective vaccine against P. falciparum malaria; development of such a vaccine is a high priority for the US military and other individuals who travel to endemic regions, and is equally important to populations residing in those areas. A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS) vaccine will 1. assess the safety and reactogenicity of candidate P. falciparum malaria vaccine FMP012/GLA-SE Secondary: 2. measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent assay (ELISA) 3. assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite challenge.
Conditions Studied
Interventions
- BIOLOGICAL Group 1: 10 ug FMP012 with 2 ug GLA-SE
- BIOLOGICAL Group 2: 10 ug FMP012 with 5 ug GLA-SE
- BIOLOGICAL 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE
- OTHER Controlled group-Challenged Only: no vaccination
Study Locations (1)
Maryland
- Clinical Trials Center, WRAIR - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01540474
The ClinicalTrials.gov registry entry for NCT01540474 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 (86% lower). The listed sponsor is U.S. Army Medical Research and Development Command, which has 77 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 4 interventions - of which Group 1: 10 ug FMP012 with 2 ug GLA-SE is the first listed.
NCT01540474 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01540474 about?
NCT01540474 is a clinical study titled "Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults". Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for protecting troops against malaria are i...
What is the current status of trial NCT01540474?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-02. Estimated completion is 2012-12.
What conditions does trial NCT01540474 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT01540474?
The interventions under investigation include: Group 1: 10 ug FMP012 with 2 ug GLA-SE (BIOLOGICAL), Group 2: 10 ug FMP012 with 5 ug GLA-SE (BIOLOGICAL), 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE (BIOLOGICAL), Controlled group-Challenged Only: no vaccination (OTHER).
Who is sponsoring clinical trial NCT01540474?
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 NCT01540474 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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Related
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