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NCT02174978 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) to Evaluate the Safety and Efficacy of the Plasmodium Falciparum Vaccine Candidate FMP012 Administered Intramuscularly With AS01B Adjuvant System 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
- 39
- Enrollment target
NCT02174978: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
NCT02174978 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02174978, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by GlaxoSmithKline (GSK) Biologicals. It is a formulation based on liposomes mixed with the immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria (QS)-21. The immunogenicity and efficacy of this new candidate vaccine will be evaluated in addition to safety.
Interventions
- BIOLOGICAL FMP012 with AS01B adjuvant system
- OTHER P falciparum Controlled Human Malaria Infection (CHMI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
What the finished NCT02174978 record still lists
NCT02174978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which FMP012 with AS01B adjuvant system is the first listed.
NCT02174978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02174978 about?
NCT02174978 is a clinical study titled "Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) to Evaluate the Safety and Efficacy of the Plasmodium Falciparum Vaccine Candidate FMP012 Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults". The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by GlaxoSmithKline (GSK) Bi...
What is the current status of trial NCT02174978?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2014-08. Estimated completion is 2015-10.
What interventions are being tested in trial NCT02174978?
The interventions under investigation include: FMP012 with AS01B adjuvant system (BIOLOGICAL), P falciparum Controlled Human Malaria Infection (CHMI) (OTHER).
Who is sponsoring clinical trial NCT02174978?
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 NCT02174978's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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