cutaneous leishmaniasis. Cutaneous leishmaniasis
Conditions
Interventions
In this study, 5 volunteers will be received 10 ug of nanoliposomal soluble Leishmania antigen (SLA) vaccine, 5 volunteers will received 50 ug of the vaccine, and 5 other volunteers will be received 2
Sponsors
National Institute for Medical Research Development
Mashhad University of Medical Sciences
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: Healthy adults without a history of leishmaniasis Healthy adults without contact with leishmaniasis antigens Who are willing to participate in the study and sign an informed consent
Exclusion criteria
Exclusion criteria: People under 16 years old People over 60 years old People with a history of leishmaniasis Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local reactions at the site of vaccine injection including swollen, inflammation, and ulcers. Timepoint: Half an hour after vaccine injection and 24 and 48 hours after vaccine injection. Method of measurement: Eye-tracking and stiffness by touching and measurement using a caliper.;General reaction after vaccine injection such as fever. Timepoint: 24-48 hours after vaccine injection. Method of measurement: Using a thermometer.;A blood test. Timepoint: Before intervention, 24, and 72 hours after injection. Method of measurement: Routine blood biochemistry tests.;Evaluation of liver enzymes such as ALT, AST levels. Timepoint: Before intervention, 24, and 72 hours after injection. Method of measurement: Routine blood biochemistry tests.;Renal function tests such as BUN. Timepoint: Before intervention, 24, and 72 hours after injection. Method of measurement: Routine blood biochemistry tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| In vitro Interferon gamma measurements. Timepoint: Before and 20 days after injection. Method of measurement: The production of gamma interferon in cell culture supernatant of peripheral blood mononuclear cells (PBMCs) from vaccinated volunteeres will be studied in vitro after stimulation with relevant antigen by the use of enzyme-linked immunosorbent assay (ELISA) kits.;Leishmanin test. Timepoint: Before, 24, and 72 hours after vaccine injection. Method of measurement: Evaluation of stiffness and erythema by observation and measurement of stiffness using caliper.;Evaluation of side effects at the lesion site (nodule, ulcer, redness), physical exam. Timepoint: After each injections and one week after injection. Method of measurement: Observation and physical exam.;In vitro IL-5 measurements. Timepoint: Before and 20 days after injection. Method of measurement: The production of interleukin 5 (IL-5) in cell culture supernatant of peripheral blood mononuclear cells (PBMCs) from vaccinated volunteeres will be studied in vitro after stimulation with relevant antigen by the use of enzyme-linked immunosorbent assay (ELISA) kits. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Khamesipor
Tehran University of Medical Sciences
Outcome results
None listed