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NCT01994525 · ClinicalTrials.gov registry record · Phase 1
Immunization Via Mosquito Bite With Radiation-attenuated Sporozoites
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01994525: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
NCT01994525 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01994525, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This study is to assess the safety, tolerability, and biomarkers of protection in healthy malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected (mock-immunization).
Primary Outcome
Occurrence of solicited adverse events (AE) from administration of study immunization (PfRAS)
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL PfRAS
- OTHER Challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2014-01-24 |
| Est. Completion | 2017-02 |
| Phase | Phase 1 |
What the finished NCT01994525 record still lists
NCT01994525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01994525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01994525 about?
NCT01994525 is a clinical study titled "Immunization Via Mosquito Bite With Radiation-attenuated Sporozoites". This study is to assess the safety, tolerability, and biomarkers of protection in healthy malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected (mock-immunization).
What is the current status of trial NCT01994525?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2014-01-24. Estimated completion is 2017-02.
What interventions are being tested in trial NCT01994525?
The interventions under investigation include: Placebo (BIOLOGICAL), PfRAS (BIOLOGICAL), Challenge (OTHER).
Who is sponsoring clinical trial NCT01994525?
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 NCT01994525's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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