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 Leishmania Tropica Skin Test Antigen (LtSTA)
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2008
CompletedFirst Posted
Study publicly available on registry
March 11, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
December 6, 2012
CompletedNovember 20, 2013
October 1, 2013
1.1 years
March 3, 2008
July 19, 2012
October 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
74 days
Study Arms (3)
LtSTA 15 ug
ACTIVE COMPARATORNaive 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.
LtSTA 30 ug
ACTIVE COMPARATORNaive 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.
LtSTA 50 ug
ACTIVE COMPARATORNaive 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.
Interventions
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.
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 Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
California Research Foundation
San Diego, California, 92103-6204, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stewart Nielsen
- Organization
- Nielsen BioSciences, Inc.
Study Officials
- STUDY DIRECTOR
Harry S Nielsen, Ph.D.
Nielsen BioSciences, Inc.
- PRINCIPAL INVESTIGATOR
Donald M Brandon, M.D.
California Research Foundation
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2008
First Posted
March 11, 2008
Study Start
August 1, 2008
Primary Completion
September 1, 2009
Study Completion
January 1, 2010
Last Updated
November 20, 2013
Results First Posted
December 6, 2012
Record last verified: 2013-10