Leishmania Skin Test
Abstract
A phase IIB study was conducted to evaluate the sensitizing properties of LtSTA in na ve adult volunteers. Three doses of the product were administered intradermally at 30 day intervals. The doses administered were 15 g, 30 g and 50 g. Study subjects received the same dose each time the product was injected on the forearm. Positive and negative skin test controls were applied concurrently with LtSTA to insure accurate readings. Positive delayed-type hypersensitivity reactions did not occur on the first and second skin test with the 30 g and 50 g doses. However, a positive skin test was observed in some individuals who received the 30 g and 50 g doses on the third skin test. Positive tests were not observed to the 15ug dose on the third skin test, but fewer subjects participated in the 15 g cohort. Based on the results of a phase II study conducted in 2007 and the phase IIB study conducted in 2009, a dose of 50 g will be used in the design of a phase III clinical trial.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 01, 2010
- Accession Number
- ADA567005
Entities
People
- H. S. Nielson Jr.