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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: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events were evaluated for 7 days after each vaccination during the vaccine phase.
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 |
What the finished NCT01157897 record still lists
NCT01157897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which VMP001 is the first listed.
NCT01157897 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01157897's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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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