Cutaneious leishmaniasis still affects about 10 million people a year, despite numerous attempts at vector control, parasite eradication, and creation of various vaccine formulations. With the cooperation of the Genetics Institute (Cambridge, MA), which makes recombinant human and murine IL-12 and Biobras (Montes Claros, Brazil), which makes a leishmania vaccine and skin test antigen, we are developing a product for use in a human Phase I/II trial . We have just completed a series of experiments using mice to test the safety, potency, efficacy and stability of several preparations. The vaccine antigen is made from cultures of parasites that are washed then frozen and thawed several times to break the cells. These crude preps were shown to work well despite autoclaving and the autoclaved preparation remains stable-after 1 month at 37. Monkey experiments are in progress to evaluate the safety immunogenicity, and efficacy of the autoclaved preparation with rHuIL-12 as an adjuvant. We plan to submit an IND for the combination of the products and begin the clinical trials at NIH by the end of the year.
