MedDataX Logo

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

NCT ID: NCT00633009

Last Updated: 2013-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cutaneous Leishmaniasis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Leishmania tropica Skin Test Antigen (LtSTA)

Intervention Type BIOLOGICAL

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)

Intervention Type BIOLOGICAL

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

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.

Group Type ACTIVE_COMPARATOR

Leishmania tropica Skin Test Antigen (LtSTA)

Intervention Type BIOLOGICAL

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)

Intervention Type BIOLOGICAL

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

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.

Group Type ACTIVE_COMPARATOR

Leishmania tropica Skin Test Antigen (LtSTA)

Intervention Type BIOLOGICAL

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)

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

Nielsen BioSciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Harry S Nielsen, Ph.D.

Role: STUDY_DIRECTOR

Nielsen BioSciences, Inc.

Donald M Brandon, M.D.

Role: PRINCIPAL_INVESTIGATOR

California Research Foundation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

California Research Foundation

San Diego, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.allermed.com

Allermed Laboratories, Inc.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LtSTA-08

Identifier Type: -

Identifier Source: org_study_id