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A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine (Recombinant Three-antigen Leishmania Polyprotein LEISH-F2 With Adjuvant MPL-SE in Combination With Sodium Stibogluconate in the Treatment of Patients With Post Kala-Azar Dermal Leishmaniasis.

Trial Profile

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine (Recombinant Three-antigen Leishmania Polyprotein LEISH-F2 With Adjuvant MPL-SE in Combination With Sodium Stibogluconate in the Treatment of Patients With Post Kala-Azar Dermal Leishmaniasis.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Sep 2021

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At a glance

  • Drugs LEISH-F3 peptide vaccine (Primary) ; Monophosphoryl lipid A (Primary) ; Sodium stibogluconate
  • Indications Visceral leishmaniasis
  • Focus Adverse reactions; Pharmacodynamics

Most Recent Events

  • 27 Jun 2011 Biomarkers information updated
  • 24 Jun 2011 Actual end date (Apr 2011 ) added as reported by ClinicalTrials.gov.
  • 24 Jun 2011 Status changed from recruiting to completed as reported by ClinicalTrials.gov.

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