Mechanism of MIP immunotherapy in multibacillary leprosy
Phase 4
- Conditions
- Health Condition 1: A304- Borderline lepromatous leprosyHealth Condition 2: A303- Borderline leprosyHealth Condition 3: A302- Borderline tuberculoid leprosyHealth Condition 4: A305- Lepromatous leprosyHealth Condition 5: A301- Tuberculoid leprosy
- Registration Number
- CTRI/2023/12/060545
- Lead Sponsor
- eprosy Research Initiative (LRI), Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. New leprosy case (before the start of MDT)
2. Age above 15 years, and with a bacteriological index (BI) of >2
3. The patients meeting the above criteria and also willing to be tested for lepromin reactivity will be considered for inclusion. Lepromin reactivity will be tested as per the standard method
Exclusion Criteria
1. Age below 15 years
2. Unable or unwilling to provide written informed consent
3. Pregnancy and Lactation
4. Other dermatological or mycobacterial diseases
5. Patients with co-morbidities like Diabetes
6. HIV, primary or secondary immune suppression
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparative Immunoprofilling in vaccinated & non vaccinated patients using Flow Cytometry and <br/ ><br>Differential gene expression study by comparative transcriptomics using RNA SequencingTimepoint: Baseline, <br/ ><br>12 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method (i)Genotyping & drug resistance profile of the M. leprae. <br/ ><br>(ii)Adverse effects (if any) will be noted by the Physician upon complained by the patient. <br/ ><br>Assessment of clinical progression, occurrence, and changes in histological upgrading. <br/ ><br>Timepoint: 3 months, <br/ ><br>6 months, <br/ ><br>12 months <br/ ><br>