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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: Completed Phase 1 study of Malaria, Falciparum, sponsored by U.S. Army Medical Research and Development Command.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured through adverse event collection and immunogenicity results
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 |
What the finished NCT01556945 record still lists
NCT01556945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Malaria, Falciparum
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 NCT01556945's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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