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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LtSTA 15 ug | Active Comparator | 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. |
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| LtSTA 30 ug | Active Comparator | 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. |
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| LtSTA 50 ug | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leishmania tropica Skin Test Antigen (LtSTA) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Harry S Nielsen, Ph.D. | Nielsen BioSciences, Inc. | Study Director |
| Donald M Brandon, M.D. | California Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Research Foundation | San Diego | California | 92103-6204 | United States |
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| Label | URL |
|---|---|
| Allermed Laboratories, Inc. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 15 ug Study Group | 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. All participants received a placebo skin test concurrently with active drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Leishmania tropica Skin Test Antigen Placebo (Placebo) | 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 |
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| FG001 | 30 ug Study Group | 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 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.All participants received a placebo skin test concurrently with active drug. |
| FG002 | 50 ug Study Group | 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 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.All participants received a placebo skin test concurrently with active drug. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 15 ug Study Group | 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. |
| BG001 | 30 ug Study Group | 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 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. |
| BG002 | 50 ug Study Group | 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 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants completed. | Posted | Number | participants | 62 days |
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| 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. | Posted | Number | No. of participants with reactions | 74 days |
|
106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 15 ug Study Group | 0 | 12 | 3 | 12 | |||
| EG001 | 30 ug Study Group | 0 | 27 | 6 | 27 | |||
| EG002 | 50 ug Study Group | 0 | 11 | 2 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Reported in diary. |
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| Burning | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Reported in diary. |
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| Pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Reported in diary. |
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| Body Aches | General disorders | Non-systematic Assessment | Reported in diary. |
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| Weakness | General disorders | Non-systematic Assessment | Reported in diary. |
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| Dizziness | General disorders | Non-systematic Assessment | Reported in diary. |
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| Nausea | General disorders | Non-systematic Assessment | Reported in diary. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stewart Nielsen | Nielsen BioSciences, Inc. | 858.571.2726 | stewart@nielsenbio.com |
| ID | Term |
|---|---|
| D016773 | Leishmaniasis, Cutaneous |
| D007896 | Leishmaniasis |
| D006968 | Hypersensitivity, Delayed |
| ID | Term |
|---|---|
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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