Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults
NCT01540474 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is U.S. Army Medical Research and Development Command, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01540474 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01540474?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.