Leishmaniasis diseases. Leishmaniasis
Conditions
Interventions
Intradermal injection of 0.1 milliliter of leishmanin antigen into the forearm of the volunteers.
Diagnosis
Intradermal injection of 0.1 milliliter of leishmanin antigen into the forearm of the volunteers
Sponsors
Cellestis (R & D) Pty Ltd
Pasteur Institute of Iran
Eligibility
Sex/Gender
All
Age
15 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria:? Sensitivity studies: Volunteers will be recruited from different foci where there is no question about the causative agent, either L. major, L. tropica, or L. infantum. Specificity studies: Volunteers from non-endmic areas who have not spent extensive periods of time in endemic areas of Iran, especially during the sand fly season. Exclusion Criteria: Sensitivity Studies: a. No documented history of infection. b. A medical condition associated with immunosuppression, such as HIV infection, silicosis, cancer requiring chemotherapy in the preceding 3 months, leukemia, lymphoma, gastrointestinal bypass, diabetes mellitus, renal failure, or vaccination (in past month). c. QuantiFERON®-Leishmania or Leishmanin skin test not completed. d. Pregnancy. e. Age less than 15 years (except in cases with L. infantum). Specificity Study: a. Lived, worked, or volunteered for more than 1 month in an known endemic area. b. History of Leishmania infection or treatment, or skin test positivity. c. A medical condition associated with immunosuppression such as HIV infection, silicosis, cancer requiring chemotherapy in the preceding 3 months, leukemia, lymphoma, gastrointestinal bypass, diabetes mellitus, renal failure, or vaccination (in past month). d. QuantiFERON®-Leishmania or Leishmanin skin test not completed. e. Pregnancy. f. Age less than 15 years.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of gama interferon induced by antigens. Timepoint: 24 hr after blood collection. Method of measurement: ELISA method using blood plasma induced by Leishmania antigen B. | — |
Secondary
| Measure | Time frame |
|---|---|
| Leishmanin skin test response. Timepoint: 48 hours after injection of leishmanin antigen. Method of measurement: Measuring mean diameter of indurations induced in the injection site by millimeter graduated ruler. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hossein Alimohammadian
Pasteur Institute of Iran
Outcome results
None listed