Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00001906 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants
A Phase 1 study of Cutaneous Leishmaniasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00001906: Completed Phase 1 study of Cutaneous Leishmaniasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001906 is a Phase 1 study of Cutaneous Leishmaniasis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001906, a Phase 1 study of Cutaneous Leishmaniasis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection of the skin, has been possible for decades using live parasites, the production and storage of live cultures are difficult. Since inoculation occasionally leads to severe infection, most experts now advocate against their use. We have shown excellent protection using a "heat-killed" vaccine that combines autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants in a rhesus macaque model of disease. To assess the safety and immunogenicity of this vaccine in humans, we now propose a rhIL-12 dose escalation Phase I/II trial.
Conditions Studied
Interventions
- BIOLOGICAL Combination of autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 1999-04 |
| Est. Completion | 2001-05 |
| Phase | Phase 1 |
What the finished NCT00001906 record still lists
NCT00001906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Cutaneous Leishmaniasis appearing as the primary indexed condition, and to 1 intervention - of which Combination of autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants is the first listed.
NCT00001906 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001906 about?
NCT00001906 is a clinical study titled "Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants". While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection of the skin, has been possible for decades using live parasites, the production and storage of live cultures are difficult. Since inoculation occasionally leads to severe infection, most experts now advocate ...
What is the current status of trial NCT00001906?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 1999-04. Estimated completion is 2001-05.
What conditions does trial NCT00001906 study?
This clinical trial studies the following conditions: Cutaneous Leishmaniasis.
What interventions are being tested in trial NCT00001906?
The interventions under investigation include: Combination of autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001906?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001906 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001906's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
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