Effect of addition of MIP vaccine or BCG vaccine in addition to standard medicines in treatment of leprosy

An open label assessor-blind, phase III multi-centric, randomized controlled study trial to evaluate the immunotherapeutic efficacy of Mycobacterium Indicus Pranii (MIP) vaccine, Bacillus Calmette Guerin(BCG) vaccine as an adjunct to chemotherapy in Multibacillary (MB) patients of leprosy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036335

Enrollment

413

Registered

2021-09-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L50- Urticaria

Interventions

Intervention1: Mycobacterium Indicus Pranii (MIP) vaccine and standard WHO multibacillary multidrug therapy (MBMDT): 0.1 ml of Mycobacterium Indicus Pranii (MIP) injected intra-dermal in the deltoid a

Eligibility

Inclusion criteria

Inclusion criteria: 1. Treatment naÃ¯ve cases of MB leprosy andMB leprosy cases where treatment has been initiated within last 3 months; 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: 1. 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
Histological parameters: 1. Granuloma index/fraction. (The granuloma fraction is the proportion of the dermis occupied by granuloma in histological sections of skin biopsies and will be expressed as 0-100%) 2. Bacillary index of granuloma. Ridleys logarithmic scale will be used to evaluate the bacillary load on histology (bacillary index of the granuloma).Timepoint: Baseline, 12 months, 24 months	—

Secondary

Measure	Time frame
Adverse effects as noted by the Physician or complained of by the patientTimepoint: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Improvement in muscle powerTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Improvement in sensation of lesions or sensory lossTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Reduction in the size of lesionsTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Reduction of erythema of lesionsTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Reduction of infiltration of lesionsTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months	—

Measure

Time frame

Adverse effects as noted by the Physician or complained of by the patientTimepoint: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Improvement in muscle powerTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Improvement in sensation of lesions or sensory lossTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Reduction in the size of lesionsTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Reduction of erythema of lesionsTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months;Reduction of infiltration of lesionsTimepoint: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

—

Countries

India

Contacts

Public ContactTarun Narang

PGIMER, Chandigarh

narangtarun@yahoo.co.in9316063166

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026