At a glance
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Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants
In Brief
A Phase 1 clinical trial evaluating Combination of autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants for Cutaneous Leishmaniasis. Completed, across 1 site.
Detailed Summary
While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection of the skin, has been possible for decades using live parasites, the production and storage of live cultures are difficult. Since inoculation occasionally leads to severe infection, most experts now advocate against their use. We have shown excellent protection using a "heat-killed" vaccine that combines autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants in a rhesus macaque model of disease. To assess the safety and immunogenicity of this vaccine in humans, we now propose a rhIL-12 dose escalation Phase I/II trial.