Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128193
Status:
COMPLETED
Last Update Posted:
2014-12-24
First Post:
2005-08-05
Brief Title:
Leprosy Skin Test Antigens Trial
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Two New Leprosy Skin Test Antigens MLSA-LAM and MLCwA Phase II Study in a Leprosy-Endemic Region
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy The study will evaluate the new skin tests that may aid in measuring the number of people exposed to leprosy and enable its diagnosis and treatment at an earlier stage Participants ages 18-60 living in Kathmandu Nepal will be enrolled Stages A and B of the study will use the skin test in healthy volunteers Stage C will use the skin test in high risk volunteers including individuals with leprosy healthy individuals in contact with leprosy patients and individuals with tuberculosis TB lung disease Study procedures will include injections physical exam and blood testing Injection sites will be checked several times during the participants study involvement 5 hours of time spread over approximately 1 month Volunteers screened for the study which have leprosy or tuberculosis will be treated or referred for treatment
Detailed Description:
This double-blind Phase II clinical trial will be conducted in 3 stages to evaluate 2 new leprosy skin test antigens Mycobacterium M leprae Soluble Antigen MLSA-Lipoarabinomannan LAM and M leprae Cell Wall Antigen MLCwA as diagnostic-epidemiological tools designed to measure incidence of leprosy infection in Kathmandu Nepal a leprosy endemic area Stage A will provide an initial indication of safety of the 2 new test antigens in 10 healthy members of the leprosy endemic population 5 subjects per antigen at 2 dosages each Stage B will expand this analysis by an additional 90 healthy subjects 45 subjects per antigen If any subjects in Stage A or B show ulcerations at the 10 mcg dose of MLSA-LAM or MLCwA test sites then only the 01 mcg dose will be used for Stage C The final stage Stage C is divided into 2 parts The first part Stage C-1 will assess safety of both antigens at the high dose 10 mcg in populations at a higher risk of developing ulcerations at skin test sites Eighty subjects will be recruited 20 household contacts of Borderline Lepromatous Leprosy BL Lepromatous Leprosy LL leprosy patients 20 BLLL leprosy patients 20 Borderline Tuberculoid Leprosy BT Tuberculoid Leprosy TT patients and 20 tuberculosis TB patients The second part Stage C-1b is a continuation of Stage C-1 with the same number of subjects recruited from the same groups to assess the reactivity of both antigens at the low dose 01 mcg This study will define a positive skin test reaction for MLSA-LAM and MLCwA and this definition will be used in estimating sensitivity and specificity for each skin test antigen and dosage It is expected that the BTTT leprosy patients and healthy contacts of leprosy patients will have larger indurations at both M leprae-derived antigen sites and a variable reaction at the tuberculinPurified Protein Derivative PPD site The non-contacts BLLL leprosy patients and TB patients will have smaller indurations at all leprosy skin test sites and a variable reaction at the tuberculinPPD site Finally the TB patients will react with a large induration at the tuberculinPPD site Primary study objectives are to evaluate safety of these 2 new leprosy skin test antigens and to estimate specificity and sensitivity of these skin test antigens in detecting M leprae infection by selecting a dosage of the MLSA-LAM and MLCwA antigens that causes minimal induration in healthy non-exposed subjects selecting a size of induration that will serve as a definition of a positive skin test reaction for MLSA-LAM and MLCwA in leprosy patients and comparing proportion of positive skin test reactors in healthy subjects to proportion in BTTT and BLLL leprosy patients contacts of leprosy patients and TB patients Secondary study objectives are to compare mean size of induration in response to each test antigen in healthy subjects versus BTTT and BLLL leprosy patients contacts of leprosy patients and TB patients as a measure of specificity and sensitivity to compare the specificity and sensitivity of the 2 new antigens with tuberculinPPD in patients with clinical leprosy contacts of leprosy patients and healthy unexposed subjects non-patient contacts to quantify release of IFN-gamma from lymphocytes in whole blood from leprosy patients leprosy patient contacts TB patients and healthy nonexposed subjects following in vitro stimulation with leprosy skin test antigens and PPD using the QuantiFERON-CMI Cellestis Limited Valentia California kit Results will be compared to the magnitude of the skin test response and to determine if antibodies against a M leprae specific anti
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None