Health Condition 1: A309- Leprosy, unspecified
Conditions
Interventions
Intervention1: MIP vaccine: Mycobacterium Indicus Pranii vaccine will be given in a single dose of 0.2ml, divided in left and right arms, intradermally
Control Intervention1: NIL: NIL
Sponsors
State Health System Resource Centre Gujarat
Eligibility
Inclusion criteria
Inclusion criteria: All patients of leprosy, whether newly diagnosed or already on treatment, whether on multidrug therapy for leprosy or not, but developing late reactions or relapse and willing to provide a written, informed consent for participation and complete follow up, will be included
Exclusion criteria
Exclusion criteria: Pregnant females, breast feeding mothers, patients with severe lepra reactions requiring hospitalization, patients unable to attend scheduled follow ups or not willing to give consent for intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and bacteriological improvement assessed by clinical assessment, slit skin smear, skin biopsyTimepoint: Clinical assessment at baseline and at 2 months,4 months,6 months and 12 months, slit skin smear at baseline and 6 months and 12 months, skin biopsy at baseline and at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of frequency & severity of lepra reactions & safety profile of vaccineTimepoint: Clinical assessment & adverse event monitoring at baseline & months 2,4,6 & 12 | — |
Countries
India
Contacts
Public ContactRima Joshi
B.J. Medical College and Civil Hospital
Outcome results
None listed