Repeated phase III randomized vaccine trial of single dose of the gentamicin-attenuated line of Leishmania major H-line against cutaneous leishmaniasis in in Vrznh in Isfahan Province and Zrghan in Fars Provinces.
Phase 3
Recruiting
- Conditions
- eishmaniasis.Cutaneous leishmaniasis
- Registration Number
- IRCT20151019024604N3
- Lead Sponsor
- Kerman University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5000
Inclusion Criteria
Otherwise healthy;
age: 3-75 years
sign the consent form willingly to participate in this study.
Exclusion Criteria
History of leishmaniasis or any scar resembling cutaneous leishmaniasis
pregnancy
acute or chronic diseases
history of allergy
history of vaccination in the previous month
immune deficiency or immune suppression therapy.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunity to cutaneous leishmaniasis. Timepoint: 4 weeks after immunization. Method of measurement: Observation lesion - Sampling from the lesion for laboratory diagnosis.
- Secondary Outcome Measures
Name Time Method Redness; swelling of the vaccine injection site. Timepoint: 12-24 hours after vaccination. Method of measurement: Measuring redness and swelling.;Pain and itch the injection site of the vaccine and axillary lymphadenopathy. Timepoint: 12-24 hours after vaccination. Method of measurement: observation.