A Phase 1 interventional study of Leish-111f + MPL-SE vaccine in Cutaneous Leishmaniasis, sponsored by Access to Advanced Health Institute (AAHI). Completed at 1 site in Colombia. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-05-05.
Sponsored by Access to Advanced Health Institute (AAHI) · Phase 1, Interventional, and Prevention
This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with a previous exposure to the Leishmania parasite (but without current or past history of leishmaniasis).
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 1, open-label study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-positive 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). The vaccine will be given to each study subject three times at 4 week intervals.
185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 133 interventional studies indexed under Leishmaniasis.
Browse Leishmaniasis studies →Access to Advanced Health Institute (AAHI) is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adverse events
Dose-limiting toxicities: hematology and serum chemistries at Screening and Days 7, 35, 63, and 84
IgG and T-cell responses to the Leish-111f protein: immunological evaluations at Days 0, 84, and 168
Skin test reactivity to the Leish-111f protein at Days 0, 84, and 168
This study is completed, as verified in May 2006. You cannot join it, but the record below documents what was studied.
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Access to Advanced Health Institute (AAHI)