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

Purpose

The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the antigen solution and the product's 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.

Condition	Intervention	Phase
Cutaneous Leishmaniasis	Biological: Leishmania tropica Skin Test Antigen (LtSTA) Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Screening
Official Title:	A Blinded, Placebo Controlled Study Evaluating Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen (LtSTA)

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis

U.S. FDA Resources

Further study details as provided by Allermed Laboratories, Inc.:

Primary Outcome Measures:

Sensitizing Effects of LtSTA in Leishmania Naive Adults [ Time Frame: 62 days ] [ Designated as safety issue: No ]
Skin test response of subjects in the trial were evaluated 48 hours post injection after each of three skin test given at 30 day intervals in naive individuals (no exposure to the Leishmania organism). (Actual times 0, 30 and 60 days).The outcome measure was designated as number of participants who became sensitized to the Leishmania antigen. This is defined as those participants that had a negative skin test result, followed by a positive response in a subsequent skin test without having been exposed to the Leishmania organism.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Local and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.

Enrollment:	50
Study Start Date:	August 2008
Study Completion Date:	January 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: LtSTA 15 ug 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.	Biological: Leishmania tropica Skin Test Antigen (LtSTA) Administer 15 ug, 30 ug or 50 ug of LtSTA into DTH positive volunteers. Repeat drug administration 30 days after initial injection and 60 days after initial injection. Read and interpret reaction 48 hours after each injection. Observe subjects for conversion or adverse reaction. Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo) Administer Placebo concurrently with 15 ug, 30 ug and 50 ug doses of LtSTA. Read and interpret the reaction 48 hours after injection. Observe subjects for reaction to Placebo
Active Comparator: LtSTA 30 ug 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 testes 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.	Biological: Leishmania tropica Skin Test Antigen (LtSTA) Administer 15 ug, 30 ug or 50 ug of LtSTA into DTH positive volunteers. Repeat drug administration 30 days after initial injection and 60 days after initial injection. Read and interpret reaction 48 hours after each injection. Observe subjects for conversion or adverse reaction. Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo) Administer Placebo concurrently with 15 ug, 30 ug and 50 ug doses of LtSTA. Read and interpret the reaction 48 hours after injection. Observe subjects for reaction to Placebo
Active Comparator: LtSTA 50 ug 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 testes 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.	Biological: Leishmania tropica Skin Test Antigen (LtSTA) Administer 15 ug, 30 ug or 50 ug of LtSTA into DTH positive volunteers. Repeat drug administration 30 days after initial injection and 60 days after initial injection. Read and interpret reaction 48 hours after each injection. Observe subjects for conversion or adverse reaction. Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo) Administer Placebo concurrently with 15 ug, 30 ug and 50 ug doses of LtSTA. Read and interpret the reaction 48 hours after injection. Observe subjects for reaction to Placebo

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633009

Locations

United States, California
California Research Foundation
San Diego, California, United States, 92103-6204

Sponsors and Collaborators

Allermed Laboratories, Inc.

U.S. Army Medical Research and Materiel Command

Investigators

Study Director:	Harry S Nielsen, Ph.D.	Allermed Laboratories, Inc.
Principal Investigator:	Donald M Brandon, M.D.	California Research Foundation

More Information

Additional Information:

Allermed Laboratories, Inc. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allermed Laboratories, 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:	December 5, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Allermed Laboratories, Inc.:

Leishmaniasis
Delayed-Type Hypersensitivity (DTH)
Skin Test
Conversion
Prior exposure to Leishmania major

Additional relevant MeSH terms:

Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections

Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on June 13, 2013