Microneedles for Diagnosis of LTBI
Study Details
Study Description
Brief Summary
This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: volunteers two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection |
Diagnostic Test: TST vs PPD microneedle test
TST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation
|
Outcome Measures
Primary Outcome Measures
- size of induration at 48 hours post-PPD injection [48 hours]
Monitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests
Eligibility Criteria
Criteria
Inclusion Criteria:
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Sex : Male and Female
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Age : 20-60 years
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TB contacts or those at risk of TB e.g. health-care workers
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HIV-negative healthy individuals
Exclusion Criteria:
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Presence of an acute infection, as determined by investigators
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Receiving immunosuppression drugs e.g. steroids
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Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous)
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Being pregnant or breastfeeding
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Faculty of Medicine, Chulalongkorn University | Bangkok | Thailand | 10330 |
Sponsors and Collaborators
- The HIV Netherlands Australia Thailand Research Collaboration
- National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)
Investigators
- Principal Investigator: Sivaporn Gatechompol, MD, The HIV Netherlands Australia Thailand Research Collaboration
- Principal Investigator: Jeerapond Leelawattanachai, PhD, King Chulalongkorn Memorial Hospital
- Principal Investigator: Saradee Warit, PhD, King Chulalongkorn Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HIV-NAT 276