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NCT01556945 · ClinicalTrials.gov registry record · Phase 1
Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S
A Phase 1 study of Malaria, Falciparum, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT01556945 is a Phase 1 study of Malaria, Falciparum that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 72 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01556945, a Phase 1 study of Malaria, Falciparum, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS, combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines can prevent malaria infection. The RTS,S vaccine contains a malaria protein in combination with a portion of the commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein. The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd vaccination.
Conditions Studied
Interventions
- BIOLOGICAL FMP1/AS02
- BIOLOGICAL RTS,S/AS02
- OTHER AS02 adjuvant alone
- OTHER Malaria challenge
Study Locations (1)
Maryland
- WRAIR Clinical Trials Center - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2001-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01556945
The ClinicalTrials.gov registry entry for NCT01556945 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 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 77 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malaria, Falciparum appearing as the primary indexed condition, and to 4 interventions - of which FMP1/AS02 is the first listed.
NCT01556945 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01556945 about?
NCT01556945 is a clinical study titled "Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S". The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS, combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines can prevent malaria infectio...
What is the current status of trial NCT01556945?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2001-04.
What conditions does trial NCT01556945 study?
This clinical trial studies the following conditions: Malaria, Falciparum.
What interventions are being tested in trial NCT01556945?
The interventions under investigation include: FMP1/AS02 (BIOLOGICAL), RTS,S/AS02 (BIOLOGICAL), AS02 adjuvant alone (OTHER), Malaria challenge (OTHER).
Who is sponsoring clinical trial NCT01556945?
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 NCT01556945 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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