Clinical Development
The Clinical Development team designs and implements clinical trials in support of IDRI’s mission to transform candidate vaccines, diagnostics, and therapeutics into viable tools to control neglected diseases of global importance.
Candidates are either developed by IDRI’s Preclinical Biology group or obtained from an external source through an institutional agreement. Through its extensive network of global connections, IDRI’s Clinical Development team is able to prepare and launch clinical trials almost anywhere in the world.
Currently, the team is managing trials of a Leishmania vaccine based on an antigen developed at IDRI under NIH preclinical development funding. IDRI has three Investigational New Drug (IND) applications for this vaccine. The first of these is to prevent leishmaniasis, the second is to treat cutaneous, diffuse cutaneous and mucocutaneous leishmaniasis, and the third is to treat visceral leishmaniasis (kala azar) and post-kala azar dermal leishmaniasis. Phase 1 and Phase 2 safety trials of the Leishmania vaccine in healthy adults have been completed in Tacoma, WA, and Medellín, Colombia. Phase 1 safety trials have also been completed in adult patients with mucosal leishmaniasis in Peru and cutaneous leishmaniasis in Brazil. Additional trials for treatment of diverse forms of leishmaniasis in Venezuela, India, and Sudan are planned or underway with funding from the Bill and Melinda Gates Foundation.
The Clinical Development team works in close cooperation with investigators and regulatory authorities in the countries where trials are conducted. Implementing clinical trials requires obtaining study approvals, vaccine import permits, and successfully navigating the logistical, regulatory, and ethical issues associated with recruiting volunteers and monitoring the trials.