Trial reportPLoS neglected tropical diseases2014
Safety and efficacy assessment of two new leprosy skin test antigens: randomized double blind clinical study.
Trial report in PLoS neglected tropical diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Two New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA Phase II Study in a Leprosy-Endemic Region
Phase I Study to Evaluate New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA
Who cites it
6 citing papers in PubMed, 14 citations in OpenAlex.
- Biosensor-Based Platforms for the Detection and Screening ofACS infectious diseases · 2026Review
- Leprosy research registry a global perspective: Need of hour for a newer vision in India towards zero leprosy.Indian journal of pharmacology · 2025Article
- Leprosy: A Review of Epidemiology, Clinical Diagnosis, and Management.Journal of tropical medicine · 2022Review
- Skin tests for the detection of Mycobacterial infections: achievements, current perspectives, and implications for other diseases.Applied microbiology and biotechnology · 2021Review
- Development of LepReact, a defined skin test for paucibacillary leprosy and low-level M. leprae infection.Applied microbiology and biotechnology · 2020Article
- The challenge of producing skin test antigens with minimal resources suitable for human application against a neglected tropical disease; leprosy.PLoS neglected tropical diseases · 2014Article
Corrections and comments
- Erratum issuedKunwar, Chatra B [corrected to Kunwar, Chhatra B]
Authors and funding
23 authors at 5 institutions in 2 countries.
Funding
Abstract
backgroundNew tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials.
methodsA Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.). Healthy non-exposed subjects (n = 10) received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg) of MLSA-LAM (n = 5) or MLCwA (n = 5) and control antigens [Rees MLSA (1.0 µg) and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal), but involved only the 1.0 µg (high dose) and 0.1 µg (low dose) of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose), each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients, 20 household contacts of leprosy patients (HC), and 20 tuberculosis (TB) patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration.
findingsIn the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50) showed induration against the high dose of each antigen, and 4% (2 of 50) reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens showed lower specificity (70% and 60%) and sensitivity (10% and 15%). BL/LL leprosy patients were anergic to the leprosy antigens.
interpretationMLSA-LAM and MLCwA at both high (1.0 µg) and low (0.1 µg) doses were found to be safe for use in humans without known exposure to leprosy and in target populations. At a sensitivity rate of 20-25% these antigens are not suitable as a skin test for the detection of the early stages of leprosy infection; however, the degree of specificity is impressive given the presence of cross-reactive antigens in these complex native M. leprae preparations.
trial registrationClinicalTrials.gov NCT01920750 (Phase I), NCT00128193 (Phase II).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.