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Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
This study is ongoing, but not recruiting participants.
Study NCT00633009   Information provided by Allermed Laboratories, Inc.
First Received: March 3, 2008   Last Updated: January 8, 2009   History of Changes

March 3, 2008
January 8, 2009
August 2008
February 2009   (final data collection date for primary outcome measure)
To determine the sensitizing effect of LtSTA on the outcome of repeat tests. [ Time Frame: 30 and 60 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00633009 on ClinicalTrials.gov Archive Site
To evaluate 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: 30 and 60 days ] [ Designated as safety issue: Yes ]
Same as current
 
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
A Blinded, Placebo Controlled Study Evaluating Safety, False-Positive Reactions and Sensitizing Properties of 15 ug, 30 ug and 50 ug Intracutaneous Doses of Leishmania Skin Test Antigen (LtSTA) in Adult Volunteers Without a History of Exposure to Leishmania Spp.

The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to determine if a 15, 30, or 50µg dose shows non-specific reactivity due to components of the antigen solution and if the product has the ability to sensitize lymphocytes of Leishmania naïve persons when administered intradermally. The presence or absence of a local inflammatory response to the first skin test with each of three doses of LtSTA will provide insight on the specificity of the antigen in a naïve population. The local inflammatory response to LtSTA following the first and second repeat skin tests will indicate if the antigen is sensitizing after intradermal administration.

 
Phase II
Interventional
Screening, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Cutaneous Leishmaniasis
  • Biological: Leishmania tropica Skin Test Antigen (LtSTA)
  • Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo)
  • Active Comparator: Naive volunteers to be tested with 15 ug injection of LtSTA.
  • Active Comparator: Naive volunteers to be tested with 30 ug injection of LtSTA.
  • Active Comparator: Naive volunteers to be tested with 50 ug injection of LtSTA.
  • Placebo Comparator: Each volunteer to be tested with an injection of LtSTA Placebo.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
36
March 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female in good health;
  • Age 18 - 60 years;
  • No past history of leishmaniasis or prior participation in a Leishmania study;
  • No prior skin test with a Leishmania antigen;
  • No occupational, residential, or travel exposure to Leishmania;
  • Positive Candin® or Trichophyton skin test (>= 5 mm induration).

Exclusion Criteria:

  • History of adult atopic dermatitis, contact dermatitis to multiple agents, unexplained urticaria, or asthma;
  • Active allergic rhinitis or conjunctivitis;
  • History of allergy or reactions to phenol, polysorbate 80, or glycerol;
  • Medications: currently taking (within the last month) antihistamines or recent history of taking (within the last 1 year) corticosteroids, immunosuppressants;
  • Splenectomy;
  • Active medical disease*;

    *Active Medical Disease: Any active physical or psychiatric condition that may increase the risks associated with participation in the study or interferes with the interpretation of study results. Included chronic medical illnesses are cardiovascular disease, renal insufficiency, chronic respiratory illness, cirrhosis, chronic hepatitis, chronic pancreatitis, chronic diarrhea, malnutrition, malignancy, autoimmune disease, and asthma.

  • Pregnancy or lactating;
  • Immunization within 4 weeks;
  • History of leishmaniasis;
  • Occupational exposure to Leishmania;
  • Prior participation in a Leishmania study;
  • Prior skin test with Leishmania antigen;
  • Travel history to Leishmania endemic areas;
  • Abnormal screening lab results;
  • Keloid scar formation
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00633009
Harry S. Nielsen, Ph.D., Allermed Laboratories, Inc.
LtSTA-08
Allermed Laboratories, Inc.
U.S. Army Medical Research and Materiel Command
Study Director: Harry S Nielsen, Ph.D. Allermed Laboratories, Inc.
Principal Investigator: Donald M Brandon, M.D. California Research Foundation
Allermed Laboratories, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP