Development and Production of a Leishmania Skin Test
Abstract
Further refinement of the manufacturing process of Leishmania tropica Skin Test Antigen (LtSTA) was made during this contract period to increase the yield and robustness of the parasite during culture. Identity and potency tests for LtSTA were developed and the procedures are being validated. The analysis of dose-response, safety and efficacy data from a phase II clinical trial conducted in Sidi Bouzid, Tunisia in 2007 were compiled and analyzed, and a study report was completed and submitted to the U.S. Army and the FDA. The results of this investigation indicated that a 30ug dose could be used to determine the sensitivity and specificity of the product; the observed sensitivity of the 30ug dose was 0.85 and the observed specificity was 0.97. To evaluate the sensitizing properties of a 30ug does of LtSTA, a phase IIb study was planned and executed in August 2008. The trial was designed to determine if a 30ug dose could be administered intradermally three times without observing sensitization. The study also included 15ug and 50ug doses to evaluate the importance of product concentration in the induction of sensitivity. At the completion of this study, a Type B Meeting with the FDA will be requested to discuss the design of a phase III trial. Participants in this meeting will include Allermed personnel and members of the U.S. Army Leishmania interest group.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 01, 2009
- Accession Number
- ADA499940
Entities
People
- Harry S. Neilsen Jr.