CompletedPhase 1

Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis

Peru48 participantsStarted 2004-07

Plain-language summary

The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein, in combination with standard pentavalent antimony therapy in adult patients with mucosal leishmaniasis.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with mucosal leishmaniasis confirmed by a positive smear, in vitro culture or PCR test Exclusion Criteria: * Mucosal leishmaniasis must not involve the vocal cords or cause respiratory distress, and there must be no evidence of other disease.

What they're measuring

Occurrence of dose-limiting toxicity

Adverse events

Trial details

NCT IDNCT00111514

SponsorAccess to Advanced Health Institute (AAHI)

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Leishmaniasis, Mucocutaneous trials