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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02174978
The ClinicalTrials.gov registry entry for NCT02174978 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 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 FMP012 with AS01B adjuvant system is the first listed.
NCT02174978 reports 0 study locations.
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.
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