Cutaneous Leishmaniasis Clinical Trial
Official title:
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Leish-111f + MPL-SE Vaccine Compared to the Leish-111f Protein Alone in Montenegro Skin Test-Negative Healthy Adults
This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in adult subjects who have no evidence of previous exposure to the Leishmania parasite.
Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis,
a more serious and possibly fatal form of Leishmania disease. All available medical
therapies require weeks of treatment and cause significant toxicity.
It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune
responses. These findings argue that a vaccine that generates a T helper 1 response against
the parasite will prevent the infection and disease. This is a phase 2, randomized, double
blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity in
Montenegro skin test (MST)-negative healthy adults of an investigational vaccine being
developed for the prophylaxis of cutaneous leishmaniasis. The vaccine, identified as
Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein
(Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). In addition, the safety and
immunogenicity of the vaccine will be compared to that of the Leish-111f protein (10 μg)
given alone. The vaccine, Leish-111f protein alone or placebo will be given to each study
subject three times at 4 week intervals.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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