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A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Infectious Disease Research Institute
ClinicalTrials.gov Identifier:
NCT01011309
First received: November 9, 2009
Last updated: November 15, 2013
Last verified: November 2013
Results First Received: September 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cutaneous Leishmaniasis
Interventions: Biological: LEISH-F2 + MPL-SE
Drug: Sodium stibogluconate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with CL were actively recruited from Andean mountain regions endemic for transmission of Leishmania peruviana. Patients were treated in a medical clinic at the Instituto de Medicina Tropical ‘Alexander von Humboldt’, Universidad Peruana Cayetano Heredia, Lima, Peru.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All eligible patients were randomized to treatment groups. One patient was mistakenly randomized (ineligible) and was not treated.

Reporting Groups
  Description
Immunotherapy v1.4/1.5 10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
Immunotherapy v1.6 10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
Chemotherapy Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.

Participant Flow:   Overall Study
    Immunotherapy v1.4/1.5     Immunotherapy v1.6     Chemotherapy  
STARTED     14     10     21  
COMPLETED     12     7     16  
NOT COMPLETED     2     3     5  
Adverse Event                 2                 1                 2  
Lack of Efficacy                 0                 1                 0  
Protocol Violation                 0                 1                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Immunotherapy v1.4/1.5 10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
Immunotherapy v1.6 10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
Chemotherapy Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
Total Total of all reporting groups

Baseline Measures
    Immunotherapy v1.4/1.5     Immunotherapy v1.6     Chemotherapy     Total  
Number of Participants  
[units: participants]
  14     10     21     45  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     14     10     20     44  
>=65 years     0     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  38.3  ± 14.2     32.7  ± 6.8     40.2  ± 16.0     38.0  ± 14.0  
Gender  
[units: participants]
       
Female     5     5     8     18  
Male     9     5     13     27  
Region of Enrollment  
[units: participants]
       
Peru     14     10     21     45  



  Outcome Measures
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1.  Primary:   Date of Clinical Cure   [ Time Frame: Day 84 ]

2.  Primary:   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 ]

3.  Secondary:   IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)   [ Time Frame: Days 0, 56 or 84, and 168 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A total of 150 patients was planned, including age de-escalation to adolescents after the first 60 adults enrolled. Owing to slow recruitment and insufficient evidence of efficacy in the immunotherapy group, enrollment was closed early.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jill Ashman, MSc, Associate Director of Clinical Operations
Organization: IDRI
phone: 206-858-6041
e-mail: jill.ashman@idri.org


No publications provided


Responsible Party: Infectious Disease Research Institute
ClinicalTrials.gov Identifier: NCT01011309     History of Changes
Other Study ID Numbers: IDRI-LCVTC-202
Study First Received: November 9, 2009
Results First Received: September 16, 2013
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration