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LtSTA 50 ug for Cutaneous Leishmaniasis

Phase 2

Waitlist Available

Led By Donald M Brandon, M.D.

Research Sponsored by Nielsen BioSciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 74 days

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.

Eligible Conditions

Cutaneous Leishmaniasis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 74 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~74 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 74 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensitizing Effects of LtSTA in Leishmania Naive Adults

Secondary study objectives

The Safety of 15, 30 and 50µg/0.1mL Doses of LtSTA in Healthy Adult Volunteers Who Have Had no Known Previous Exposure to Leishmania Parasites

Trial Design

3Treatment groups

Active Control

Group I: LtSTA 50 ugActive Control2 Interventions

Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin testes were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.

Group II: LtSTA 15 ugActive Control2 Interventions

Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.

Group III: LtSTA 30 ugActive Control2 Interventions

Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin testes were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.

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