Cutaneous LeishmaniasisPhase 2NCT00633009
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
A Phase 2 study testing Leishmania tropica Skin Test Antigen (LtSTA) in people with Cutaneous Leishmaniasis, run by Nielsen BioSciences, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Leishmania tropica Skin Test Antigen (LtSTA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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*;
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Research Foundation
San Diego, California, 92103-6204
About this study
Official title: A Blinded, Placebo Controlled Study Evaluating Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen (LtSTA)
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.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Leishmania tropica Skin Test Antigen (LtSTA), Leishmania tropica Skin Test Antigen Placebo (Placebo)
- Keywords
- Leishmaniasis, Delayed-Type Hypersensitivity (DTH), Skin Test, Conversion, Prior exposure to Leishmania major
- Medical subject headings
- Leishmaniasis, Cutaneous, Leishmaniasis, Hypersensitivity, Delayed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Leishmania tropica Skin Test Antigen (LtSTA); Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo) |
| 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. Receives: Biological: Leishmania tropica Skin Test Antigen (LtSTA); Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo) |
| 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. Receives: Biological: Leishmania tropica Skin Test Antigen (LtSTA); Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Local and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.
Measured: 74 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cutaneous LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nielsen BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Harry S Nielsen, Ph.D., Study director, Nielsen BioSciences, Inc.Donald M Brandon, M.D., Principal investigator, California Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633009
- Sponsor's protocol ID
- LtSTA-08
- Status last verified
- Oct 2013
- First submitted
- 3 Mar 2008
- Last updated
- 20 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Placebo Controlled Study Evaluating Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen (LtSTA)
- ClinicalTrials.gov ID
- NCT00633009
- Acronym / sponsor ID
- LtSTA-08
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Leishmaniasis, Delayed-Type Hypersensitivity (DTH), Skin Test, Conversion, Prior exposure to Leishmania major
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nielsen BioSciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Posted 6 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LtSTA 15 ug | Active comparator | Biological: Leishmania tropica Skin Test Antigen (LtSTA), Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo)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. |
| LtSTA 30 ug | Active comparator | Biological: Leishmania tropica Skin Test Antigen (LtSTA), Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo)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. |
| LtSTA 50 ug | Active comparator | Biological: Leishmania tropica Skin Test Antigen (LtSTA), Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | LtSTA 15 ug, LtSTA 30 ug, LtSTA 50 ug |
| 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 | Biological | LtSTA 15 ug, LtSTA 30 ug, LtSTA 50 ug |
Primary outcome
Sensitizing Effects of LtSTA in Leishmania Naive Adults
Time frame: 62 days
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.
1 secondary outcome
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
Time frame: 74 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry S Nielsen, Ph.D. study director
Nielsen BioSciences, Inc.
Donald M Brandon, M.D. principal investigator
California Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leishmania tropica Skin Test Antigen (LtSTA) in people with Cutaneous Leishmaniasis, run by Nielsen BioSciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitizing Effects of LtSTA in Leishmania Naive Adults (time frame: 62 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2013.