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

Cutaneous Leishmaniasis Clinical Trial

Official title:

A Blinded, Placebo Controlled Study Evaluating Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen (LtSTA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633009
• Other study ID #: LtSTA-08
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2008
• Last updated: October 28, 2013
• Start date: August 2008
• Est. completion date: January 2010

Study information

• Verified date: October 2013
• Source: Nielsen BioSciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	California Research Foundation	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Nielsen BioSciences, Inc.	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitizing Effects of LtSTA in Leishmania Naive Adults	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.	62 days	No
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	Local and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.	74 days	Yes

External Links

•   Allermed Laboratories, Inc.