Clinical Trial: Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-Blind, Adjuvant- and Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability, and Immunogenicity of Leish-111f + MPL-SE Vaccine With Meglumine Antimoniate (Glucan

Brief Summary: This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with cutaneous leishmaniasis.

Detailed Summary:

Cutaneous leishmaniasis is a disfiguring infection that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of leishmania infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Brazil, a standard therapy is Glucantime treatment, administered in cycles of 10 consecutive, once daily, intramuscular injections (Glucantime 10 mg/kg, maximum of 850 mg), followed by 11 consecutive days without Glucantime injections (rest days). At the completion of each cycle, a study physician examines the patient to determine if a further cycle of Glucantime treatment is indicated.

It appears that Leishmania infections can be eliminated by T helper 1 immune responses. This finding argues that a vaccine that augments cutaneous leishmaniasis patients’ T helper 1 response will eliminate the infection and disease. This study is a phase 1, randomized, double-blind, placebo controlled, sequential dose-escalating trial to evaluate the safety and immunogenicity of three injections of 5, 10, or 20 μg of Leish-111f protein + 25 μg of MPL-SE adjuvant given at 4 week intervals as an adjunct to the standard chemotherapy with Glucantime cycles, as described above in patients with cutaneous leishmaniasis.


Sponsor: IDRI

Current Primary Outcome:

  • Occurrence of dose limiting toxicity
  • Adverse events


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • IgG and T-cell response to Leish-111f vaccine
  • Leish-111f skin test reactivity
  • Safety of the vaccine with respect to the clinical course of cutaneous leishmaniasis


Original Secondary Outcome: Same as current

Information By: IDRI

Dates:
Date Received: May 23, 2005
Date Started: October 2004
Date Completion: August 2006
Last Updated: February 13, 2007
Last Verified: February 2007