A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
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|ClinicalTrials.gov Identifier: NCT01011309|
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : November 18, 2013
Last Update Posted : December 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Leishmaniasis||Biological: LEISH-F2 + MPL-SE Drug: Sodium stibogluconate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in the Treatment of Patients With Cutaneous Leishmaniasis|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||December 2011|
Experimental: LEISH-F2 + MPL-SE vaccine
Recombinant three antigen Leishmania polyprotein + MPL-SE adjuvant
Biological: LEISH-F2 + MPL-SE
10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56
Other Name: There are no other names for the vaccine.
Active Comparator: Sodium stibogluconate (SSG)
20 mg/kg/day IV for 20 days
Drug: Sodium stibogluconate
20 mg/kg/day IV daily for 20 days
Other Name: Marfan SSG
- Date of Clinical Cure [ Time Frame: Day 84 ]Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.
- Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. [ Time Frame: Day 0 through Day 84 ]Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.
- IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) [ Time Frame: Days 0, 56 or 84, and 168 ]Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011309
|Instituto de Medicina Tropical"Alexander von Humboldt"|
|Study Director:||Franco Piazza, MD, MPH||IDRI|