Skip to content

Role of leishmanin skin test in immunity of visceral leishmaniasis

Production, validation and use of leishmanin skin test for detection of Leishmania exposure and immunity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025617
Enrollment
700
Registered
2020-06-04
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: validation and use of leishmanin skin test for detection of Leishmania exposure and immunity: Treated and cured VL cases and an equal number of controls will be injected (50 μg/100μl)

Sponsors

Dr Pradeep Das
Lead Sponsor
Prof R Satoskar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Validation of LST for determining Leishmania exposure in an immune population: 100 treated-cured VL (with miltefosine or AmBisome) and 100 controls (from a non-endemic area with no VL). Identification of asymptomatic infections: 250 members from neighbors of PKDL cases and 250 members from non-endemic area. Age group: 15-65 years and either sex. Subjects willing to give written informed consent.

Exclusion criteria

Exclusion criteria: Co-infection with HIV or Tuberculosis Pregnant and lactating women. Anti cancer and immune suppressive drugs. Subjects not willing to give written informed consent. Subjects who are hepatitis B & C positive. Age group: 65 years.

Design outcomes

Primary

MeasureTime frame
This project seeks to reintroduce the LST as a tool for detection of Leishmania infection, surveillance, epidemiological studies, and future vaccine trials. With over 350 million people worldwide at risk of developing leishmaniasis, the development of a new prophylactic vaccine will have a major and far-reaching positive impact on global health.Timepoint: Two Years

Secondary

MeasureTime frame
The outcome of this project can lead to development of a vaccine for VL and thus can lead to elimination of VL from India.Timepoint: Ten Years.

Countries

India

Contacts

Public ContactDr Pradeep Das

ICMR Rajendra Memorial Research Institute of Medical Sciences

drpradeep.das@gmail.com06122636651

Outcome results

None listed

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