Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants

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.

Timeline

Start

1999-04

Primary completion

—

Completion

2001-05

Publications

• Background Guirges SY. Natural and experimental re-infection of man with Oriental sore. Ann Trop Med Parasitol. 1971 Jun;65(2):197-205. doi: 10.1080/00034983.1971.11686746. No abstract available.
• Background Naggan L, Gunders AE, Michaeli D. Follow-up study of a vaccination programme against cutaneous leishmaniasis. II. Vaccination with a recently isolated strain of L. tropica from Jericho. Trans R Soc Trop Med Hyg. 1972;66(2):239-43. doi: 10.1016/0035-9203(72)90153-8. No abstract available.
• Background Modabber F. Experiences with vaccines against cutaneous leishmaniasis: of men and mice. Parasitology. 1989;98 Suppl:S49-60. doi: 10.1017/s0031182000072243.

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