Preventing leprosy by vaccine

Leprosy Vaccine Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/07/002791

Enrollment

215000

Registered

2012-07-12

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

None listed

Interventions

Intervention1: ICRC: 10 power 9 bacilli per 0.1 ml

one single dose-intradermal Intervention2: M.w: 10 power 9 bacilli per 0.1 ml

one single dose-intradermal Intervention3: BCG + Killed M.Leprae (KML): BCG (0.05 mg per 0.1ml) + Vaccine grade KML, 6 times 10 power 8 bacilli

one single dose-intradermal Intervention4: BCG: 0.1 mg per 0.1ml

one single dose-intradermal Control Intervention1: Placebo: Normal saline

one single dose-intradermal

Eligibility

Inclusion criteria

Inclusion criteria: Healthy persons without leprosy

Exclusion criteria

Exclusion criteria: Infants below the age of 1 year, older people beyond the age of 65 years, persons with active or regressed leprosy or with known history of leprosy, obviously malnourished and debilitated people, persons known to be having tuberculosis, allergic manifestations, mental disorders and those who looked obviously ill and pregnant women.

Design outcomes

Primary

Measure	Time frame
Incidence of leprosy of all forms, with special reference to progressive and serious forms.Timepoint: Follow-up surveys during 1993-1995, 1997-98 and 1999-2002 to document incidence of leprosy	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactProf MD Gupte

National Institute of Epidemiology

directorne@dataone.in91-44-26136204

Outcome results