Status:
COMPLETED
Safety/Efficacy Trial of Killed Leishmania Vaccine in Volunteers With no Response to Leishmanin
Lead Sponsor:
Tehran University of Medical Sciences
Collaborating Sponsors:
Pasteur Institute of Iran, Tehran, Iran
Razi Vaccine and Serum Research Institute
Conditions:
Healthy
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Development of a safe and effective vaccine against leishmaniasis started more than 10 years ago under WHO/TDR supervision. An autoclaved L. major vaccine (ALM) mixed with BCG has been tested in human...
Detailed Description
Background Information Leishmaniases encompass diverse clinical manifestations produced by different species of the protozoan parasite, Leishmania, transmitted by the bites of infected female sand fli...
Eligibility Criteria
Inclusion
- Men or women age between 16 to 60 years.
- Generally in good health.
- No known immunological deficiency, including HIV infection (by medical history).
- No fever at the time of vaccination i.e. oral body temperature \<37.5°C.
- No history/suspicion/presence of kala-azar or cutaneous leishmaniasis (CL).
- No history of leishmanization.
- No history of vaccination against leishmaniasis.
- No involvement in other drug or vaccine trial(s) during the study period.
- No other known or planned vaccination within 1 month prior to the study and during the study period.
- No current or foreseeable use of immunosuppressors (i.e. corticosteroids) within one month prior to the vaccination and during the period of the study.
- No known allergy to a vaccine component (e.g. BCG, alum hydroxide, etc.).
- Written informed consent provided. If the volunteer is under 18 years old, the legal guardian's signature is required on the informed consent.
Exclusion
- Pregnancy.
- Women should not be pregnant and/or lactating and/or planning pregnancy throughout the study period until complete healing of the lesion induced by vaccination and/or leishmanization. A urinary pregnancy test will be performed for all women of child bearing potential at entry and adequate contraception throughout the study should be used if applicable.
- Evidence of prior CL or leishmaniasis (e.g. sign of scar resembling leishmaniasis, confirmed by physical examination).
- Evidence of serious diseases, allergy or allergic conditions leading to medical consultation and treatment especially with steroids or levamisole, recent surgery or hospitalisation, according to the physical examination and medical history interview.
- Presence of any chronic illness/disease including diabetes mellitus, tuberculosis, leprosy, epilepsy and hypertension.
- Abnormal haematology and clinical chemistry (See Sections 8.1.2.1 and 8.1.2.2 for normal ranges of laboratory values).
- Presence of fever at the time of vaccination, i.e. body temperature (by mouth) \> 37.5 °C.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00429715
Start Date
January 1 2007
End Date
December 1 2007
Last Update
February 17 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Research & Training in Skin Diseases & Leprosy, TUMS
Tehran, 14166, Iran