Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Nielsen BioSciences, Inc.
ClinicalTrials.gov Identifier:
NCT00633009
First received: March 3, 2008
Last updated: October 28, 2013
Last verified: October 2013
Results First Received: July 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Screening
Condition: Cutaneous Leishmaniasis
Interventions: Biological: Leishmania tropica Skin Test Antigen (LtSTA)
Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
15 ug Study Group Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. All participants received a placebo skin test concurrently with active drug.
30 ug Study Group Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
50 ug Study Group Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.

Participant Flow:   Overall Study
    15 ug Study Group     30 ug Study Group     50 ug Study Group  
STARTED     12     27     11  
COMPLETED     8     23     10  
NOT COMPLETED     4     4     1  



  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.
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Reporting Groups
  Description
15 ug Study Group Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
30 ug Study Group Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
50 ug Study Group Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
Total Total of all reporting groups

Baseline Measures
    15 ug Study Group     30 ug Study Group     50 ug Study Group     Total  
Number of Participants  
[units: participants]
  12     27     11     50  
Age  
[units: participants]
       
<=18 years     0     3     0     3  
Between 18 and 65 years     12     24     11     47  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34  ± 11     28  ± 12     35  ± 13     31  ± 12  
Gender  
[units: participants]
       
Female     9     10     4     23  
Male     3     17     7     27  
Region of Enrollment  
[units: participants]
       
United States     12     27     11     50  



  Outcome Measures
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1.  Primary:   Sensitizing Effects of LtSTA in Leishmania Naive Adults   [ Time Frame: 62 days ]

2.  Secondary:   The Safety of 15, 30 and 50µg/0.1mL Doses of LtSTA in Healthy Adult Volunteers Who Have Had no Known Previous Exposure to Leishmania Parasites   [ Time Frame: 74 days ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stewart Nielsen
Organization: Nielsen BioSciences, Inc.
phone: 858.571.2726
e-mail: stewart@nielsenbio.com


No publications provided


Responsible Party: Nielsen BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT00633009     History of Changes
Other Study ID Numbers: LtSTA-08
Study First Received: March 3, 2008
Results First Received: July 19, 2012
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration