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MIP vaccination of contacts of leprosy patients and their contacts in Haryana and Delhi

MIP vaccination of contacts of all leprosy patients and their contacts in Haryana and Delhi â?? An implementation research study in the post-elimination era - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078292
Enrollment
12600
Registered
2024-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: A30- Leprosy [Hansens disease]

Interventions

Intervention1: MIP vaccine: MIP vaccine will be given intradermally (2 separate injections of 0.5 Ã? 10 ? each) at 0 months and 6 months to contacts of leprosy patients and PB leprosy cases. In MB in

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Index patient of leprosy: Newly diagnosed patients with leprosy both paucibacillary PB and multibacillary MB, those who are already taking treatment and those who have completed treatment in the previous 1 year. Contacts of index patient of leprosy: Definitions of contact: Someone who has had prolonged regular or interrupted contact with an index case during the last one year. The minimum time period of contact will be 3 months cumulative and 20 hours per week. Contact categories: This is based on physical proximity to the index case. The categories are family contacts, household contacts, neighbor contacts, and social contacts. Family contacts comprise all family members. However, if a family member has been away due to reasons such as work or education during the last 1 year, then he will not be included among contacts. Household contacts are people living in the same house as the index case. Neighbour contacts are all people living in 3 houses on either side and 3 houses across the street from the index case. In multi-storeyed houses, people living on the same floor of the house will be considered among contacts. Social contacts include all people with whom the index case has been in contact for more than 20 hours per week for a cumulative period of 3 months or more.

Exclusion criteria

Exclusion criteria: Infants less than 1 year of age and geriatric people above 65 years of age. Contacts having clinically active signs of leprosy. They will be counselled and referred to a medical facility for treatment. Pregnant women and subjects who are HIV positive. Subjects with CNS-TB, any serious ailment, and malignancy. Patients or contacts not willing to participate or provide informed consent; however, at least three attempts would be made to convince the contact to participate before exclusion. Refusal of disclosure by the index case. Though we would counsel him, we can even vaccinate contacts without disclosing the patientâ??s identity.

Design outcomes

Primary

MeasureTime frame
Reduction of ANCDR at 3-years of MIP vaccination of leprosy patients and their contacts in Faridabad and the 3 districts of Delhi compared to historical ANCDR of 2023 of the same district (as available from NLEP data).Timepoint: 3 years

Secondary

MeasureTime frame
Reduction in other key program indicators (G2D among new cases and new child cases) in areas where MIP has been used as a targeted intervention for leprosy patients and their contacts. Timepoint: at the time of final analysis;Improvement in social acceptance over baseline acceptance as an impact of community awareness intervention. Timepoint: at time of final analysis;cost-effectiveness intervention to control of leprosy. Timepoint: at the time of final analysis

Countries

India

Contacts

Public ContactNeena Khanna

Amrita Hospital

neena_aiims@yahoo.co.in919312432689

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026