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NCT00633009 · ClinicalTrials.gov registry record · Phase 2
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
A Phase 2 study, sponsored by Nielsen BioSciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00633009: Completed Phase 2 study, sponsored by Nielsen BioSciences.
NCT00633009 is a Phase 2 study that has completed, run by Nielsen BioSciences. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00633009, a Phase 2 study, has completed, sponsored by Nielsen BioSciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the antigen solution and the product's ability to sensitize lymphocytes of Leishmania naïve persons when administered intradermally. The presence or absence of a local inflammatory response to the first skin test with each of three doses of LtSTA will provide insight on the specificity of the antigen in a naïve population. The local inflammatory response to LtSTA following the first and second repeat skin tests will indicate if the antigen is sensitizing after intradermal administration.
Primary Outcome
Skin test response of subjects in the trial were evaluated 48 hours post injection after each of three skin test given at 30 day intervals in naive individuals (no exposure to the Leishmania organism). (Actual times 0, 30 and 60 days).The outcome measure was designated as number of participants who became sensitized to the Leishmania antigen. This is defined as those participants that had a negative skin test result, followed by a positive response in a subsequent skin test without having been e
Interventions
- BIOLOGICAL Leishmania tropica Skin Test Antigen (LtSTA)
- BIOLOGICAL Leishmania tropica Skin Test Antigen Placebo (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-08 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT00633009 record still lists
NCT00633009 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Leishmania tropica Skin Test Antigen (LtSTA) is the first listed.
NCT00633009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00633009 about?
NCT00633009 is a clinical study titled "Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen". The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the antigen solution and the p...
What is the current status of trial NCT00633009?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-08. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00633009?
The interventions under investigation include: Leishmania tropica Skin Test Antigen (LtSTA) (BIOLOGICAL), Leishmania tropica Skin Test Antigen Placebo (Placebo) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00633009?
This trial is sponsored by Nielsen BioSciences, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00633009's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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