Health Condition 1: A304- Borderline lepromatous leprosy Health Condition 2: A303- Borderline leprosy Health Condition 3: A302- Borderline tuberculoid leprosy Health Condition 4: A305- Lepromatous leprosy Health Condition 5: A301- Tuberculoid leprosy
Conditions
Interventions
Intervention1: Mycobacterium Indicus Pranii (MIP) vaccine and standard WHO multibacillary multidrug therapy (MBMDT): 0.1 ml of Mycobacterium Indicus Pranii (MIP) will be injected intra-dermal in the d
Sponsors
Leprosy Research Initiative (LRI), Netherlands
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative Immunoprofilling in vaccinated & non vaccinated patients using Flow Cytometry and Differential gene expression study by comparative transcriptomics using RNA SequencingTimepoint: Baseline, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) Genotyping & drug resistance profile of the M. leprae. (ii) Adverse effects (if any) will be noted by the Physician upon complained by the patient. Assessment of clinical progression, occurrence, and changes in histological upgrading. Timepoint: 3 months, 6 months, 12 months | — |
Countries
India
Contacts
Public ContactDr Pushpendra Singh
ICMR-National Institute of Research in Tribal Health
Outcome results
None listed