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
Conditions
Interventions
Intervention1: MIP vaccine or BCG vaccine: 2 doses of MIP vaccine 0.1 ml intradermally at 0 and 3 months, or 2 doses of BCG vaccine 0.1 ml intradermally at 0 and 3 months along with the WHO multidrug
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Treatment naïve cases of MB leprosy classified according to WHO classification. 2. Age group: 12- 60 years 3. Patients willing to give consent (for patients aged 12-18years willing to give assent and consent from the legally acceptable representative)
Exclusion criteria
Exclusion criteria: Paucibacillary (PB) cases of leprosy 2. Defaulter cases 3. Relapse cases 4. Patients on steroids- prednisolone dose >20mg/day for more than 2 weeks 5. Pregnancy or breast feeding 6. With medical co-morbidities like diabetes, cancer, history of or active pulmonary tuberculosis 7. People living with HIV/AIDS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Decline in viable bacilli load by quantitative real time PCR (occurrence of persisters) before and after treatment. 2. To study the changes in immune profile of the patients in three treatment arms. Outcome measures to be interpreted as per the findings at every 6-month interval.Timepoint: Baseline, at 6 months, at 12 months, at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of clinical regression, occurrence and severity of reactions and changes in nerve function, histological upgrading.Timepoint: Baseline, at 6 months, at 12 months, at 24 months | — |
Countries
India
Contacts
Public ContactSeema Chhabra
Post Graduate Institute of Medical Sciences, Chandigarh
Outcome results
None listed