Cutaneous leishmaniasis (CL) is an infectious disease caused by the parasite Leishmania and transmitted by the bite of a small fly that occurs in tropical and subtropical regions worldwide. CL causes skin ulcers that may lead to severe disfigurement. Drugs currently used to treat CL are toxic, impractical, expensive, and not very effective. The development of a vaccine for treatment of CL is expected to contribute to the worldwide control of this disease. The broad, long-term objective is to develop a safe and effective vaccine for treatment and prevention of all forms of leishmaniasis that will contribute to worldwide control of leishmaniasis.
The aim of this grant application is to develop a research proposal for implementing a Phase 2 clinical trial to evaluate the safety and immunogenicity of the Leish-111 f + MPL-SE vaccine in the treatment of cutaneous leishmaniasis caused by Leishmania major in Tunisia. Components of this research proposal include the following: develop the study protocol, develop the informed consent form (ICF), update the investigator's brochure, evaluate the study site and study staff in Tunisia, identify any non-US regulatory requirements specific to Tunisia, obtain institutional ethics committee approval of the ICF and protocol, submit the study documents and I EC approval letters to the FDA, resolve any IND issues with the FDA, develop a manual of operations, develop a study site monitoring plan, develop a data management plan, organize safety oversight process, develop a data and safety monitoring plan, develop case report forms, develop training materials and plans for study site staff. By completing this aim we hope to be able to request funding to conduct the Phase 2 clinical trial mentioned above. Performing this trial will help us get closer to our broad long-term goal of controlling leishmaniasis. ? ? ? ?
