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NCT01157897 · ClinicalTrials.gov registry record · Phase 1
Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT01157897 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 41 participants.
The verdict
NCT01157897, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study will be performed in malaria-naïve adults in the United States. Three doses of VMP001 formulated in AS01B (adjuvant system) will be given intramuscularly at different intervals followed by a challenge with P. vivax infected mosquitoes. Safety, immunogenicity and efficacy parameters will be studied.
Interventions
- BIOLOGICAL VMP001
- OTHER P. vivax sporozoite challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01157897
The ClinicalTrials.gov registry entry for NCT01157897 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 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 0 conditions, and to 2 interventions - of which VMP001 is the first listed.
NCT01157897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01157897 about?
NCT01157897 is a clinical study titled "Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults". This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study will be performed in malaria-naïve adults in the United States. Three doses of VMP001 formulated in AS01B (adjuva...
What is the current status of trial NCT01157897?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2010-07. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01157897?
The interventions under investigation include: VMP001 (BIOLOGICAL), P. vivax sporozoite challenge (OTHER).
Who is sponsoring clinical trial NCT01157897?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
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