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

Primary Purpose

Cutaneous Leishmaniasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Leishmania tropica Skin Test Antigen (LtSTA)
Leishmania tropica Skin Test Antigen Placebo (Placebo)
Sponsored by
Nielsen BioSciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cutaneous Leishmaniasis focused on measuring Leishmaniasis, Delayed-Type Hypersensitivity (DTH), Skin Test, Conversion, Prior exposure to Leishmania major

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • California Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

LtSTA 15 ug

LtSTA 30 ug

LtSTA 50 ug

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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
Local and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.

Full Information

First Posted
March 3, 2008
Last Updated
October 28, 2013
Sponsor
Nielsen BioSciences, Inc.
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT00633009
Brief Title
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
Official Title
A Blinded, Placebo Controlled Study Evaluating Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen (LtSTA)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nielsen BioSciences, Inc.
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis
Keywords
Leishmaniasis, Delayed-Type Hypersensitivity (DTH), Skin Test, Conversion, Prior exposure to Leishmania major

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LtSTA 15 ug
Arm Type
Active Comparator
Arm Description
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.
Arm Title
LtSTA 30 ug
Arm Type
Active Comparator
Arm Description
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.
Arm Title
LtSTA 50 ug
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Leishmania tropica Skin Test Antigen (LtSTA)
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Leishmania tropica Skin Test Antigen Placebo (Placebo)
Intervention Description
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
Primary Outcome Measure Information:
Title
Sensitizing Effects of LtSTA in Leishmania Naive Adults
Description
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.
Time Frame
62 days
Secondary Outcome Measure Information:
Title
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
Description
Local and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.
Time Frame
74 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry S Nielsen, Ph.D.
Organizational Affiliation
Nielsen BioSciences, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Donald M Brandon, M.D.
Organizational Affiliation
California Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92103-6204
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.allermed.com
Description
Allermed Laboratories, Inc.

Learn more about this trial

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

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