The applicants have cloned and characterized three candidate antigens for the development of a leishmaniasis vaccine. All three antigens were selected based on their ability to induce protective Thl responses. This proposal builds upon supportive data generated during the Phase I study period that it is possible to achieve both prophylactic and therapeutic protective immune responses using recombinant antigens, as well as to influence the Thl/Th2 response profile in leishmaniasis. During the Phase II proposal period a subunit vaccine for leishmaniasis will be developed. This will be accomplished by using the best available models for experimental visceral and cutaneous leishmaniasis. Antigen combinations that are optimal for achieving long lasting protection will be developed; adjuvants that may be used in humans will be selected as well. It is anticipated that a Phase I IND will be filed before the end of the Phase II grant period.
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