Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01751048 · ClinicalTrials.gov registry record · Phase 1
LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01751048: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01751048 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01751048, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
Investigational products: LEISH-F3 (recombinant protein antigen) + GLA-SE (adjuvant) leishmaniasis vaccine and LEISH-F3 (recombinant protein antigen) + MPL-SE (adjuvant) leishmaniasis vaccine. Stage of development: Phase 1 clinical development. Healthy adult subjects, 18 to 49 will be recruited through a U.S. site. Primary objective: To evaluate the safety and tolerability of the LEISH-F3 + GLA-SE vaccine and the LEISH-F3 + MPL-SE vaccine following intramuscular (IM) administration of 20 µg of LEISH-F3 together with 2 or 5 µg of GLA-SE or 10 µg of MPL-SE on Days 0, 28, and 168. Secondary objective: To assess the immunogenicity of LEISH-F3 formulated with GLA-SE, MPL-SE, or SE by evaluating IgG antibody responses to LEISH-F3 at Days 0, 28, 56, 168, 196, and 365, and T cell responses to LEISH-F3 at Days 0, 14, 42, 168, 182, and 365. Each subject's duration of participation will be about 18 months.
Interventions
- BIOLOGICAL GLA-SE
- BIOLOGICAL LEISH-F3
- BIOLOGICAL MPL-SE
- DRUG SE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT01751048 record still lists
NCT01751048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 4 interventions - of which GLA-SE is the first listed.
NCT01751048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01751048 about?
NCT01751048 is a clinical study titled "LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine". Investigational products: LEISH-F3 (recombinant protein antigen) + GLA-SE (adjuvant) leishmaniasis vaccine and LEISH-F3 (recombinant protein antigen) + MPL-SE (adjuvant) leishmaniasis vaccine. Stage of development: Phase 1 clinical development. Healthy adult subjects, 18 to 49 will be recruited thro...
What is the current status of trial NCT01751048?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-03. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01751048?
The interventions under investigation include: GLA-SE (BIOLOGICAL), LEISH-F3 (BIOLOGICAL), MPL-SE (BIOLOGICAL), SE (DRUG).
Who is sponsoring clinical trial NCT01751048?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01751048's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01765777 · 48 participants · NA
Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
- NCT03073343 · 48 participants · NA
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
- NCT03431064 · 48 participants
Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
- NCT03514602 · 48 participants · NA
Maternal Smoking Cessation and Pediatric Obesity Prevention
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia