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Safety/Efficacy Trial of Killed Leishmania Vaccine in Volunteers With Positive Response to Leishmanin (LST>0)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429780
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : November 18, 2009
Pasteur Institute of Iran, Tehran, Iran
Razi Vaccine and Serum Research Institute
Centre for Disease Control & Management, Ministry of Health & Medical Education
Information provided by:
Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 31, 2007
First Posted Date  ICMJE February 1, 2007
Last Update Posted Date November 18, 2009
Study Start Date  ICMJE January 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
  • Occurrence of local/systemic adverse events after vaccination assessed by
  • interview, physical examination in volunteers with a response to
  • Leishmanin (LST>0);
  • Percentage of the volunteers with LST>0 protected against CL
  • (absence of a lesion).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00429780 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
  • Percentage of volunteers partially protected against CL compared to controls at day 240.
  • To assess immune response of the volunteers at baseline (prior to vaccination), before leishmanization to evaluate the immunogenicity of the vaccine.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety/Efficacy Trial of Killed Leishmania Vaccine in Volunteers With Positive Response to Leishmanin (LST>0)
Official Title  ICMJE A Randomized, Safety, Immunogenicity & Efficacy Study of Autoclaved Leishmania Major Plus BCG vs. BCG (Double Blind) or Placebo (Open), in Healthy High Risk Iranian Volunteers With Positive Response to Leishmanin (LST>0)
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 in Iran, Pakistan and Sudan. Long term follow up of the vaccinees showed no untoward reactions except the skin reaction at the site of injection. The efficacy results of ALM was not satisfactory. In order to enhance immunogenicity of the vaccine, ALM was adsorbed to alum (Aluminum hydroxide). Alum-ALM plus adjuvant showed to induce protection in Rhesus monkeys against cutaneous leishmaniasis and in Languor monkeys against visceral leishmaniasis. Two trials of a single injection of different doses of Alum-ALM mixed with 1/10th of normal dose of BCG was carried out in healthy volunteers from a non endemic area of Sudan. The safety/immunogenicity parameters of the volunteers were closely monitored and the results showed that side effects were minimal and confined to the site of injection in the form of mild local pain, induration and ulceration, all associated with BCG vaccination. The immunogenicity results showed the strongest immune response seen in any Leishmania vaccine trials so far. It seems that this new formulation is an appropriate candidate for further development. Inoculation with live virulent Leishmania to produce a lesion for the purpose of preventing natural infection is known as leishmanization. The induced lesion heals and the person is usually protected against further infections. This method of prevention was practiced for centuries in the region. In this study volunteers with response to leishmanin will be injected twice (30 days apart) with Alum-ALM 200 ug + 1/10 of BCG (n = 50) or diluent alone (n = 50) as control. All volunteers will be leishmanized on day 60 post vaccination. In this trial, volunteers are protected either by vaccine or by leishmanization. The leishmanized volunteers will be visited by weekly and the development and healing process of the lesion will be monitored until complete healing of every volunteer. The immune responses of the volunteers will be evaluated. Vaccine efficacy is defined by the percent reduction in the number of volunteers developing a lesion following leishmanization as compared to controls on days 240.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE Biological: Alum-ALM + BCG
Alum-ALM + BCG 200 ug per injection
Other Name: Alum pericipitated autoclaved L. major
Study Arms  ICMJE
  • No Intervention: Alum-ALM + BCG
    Alum-ALM + BCG
  • No Intervention: Placebo
    BCG diluent
    Intervention: Biological: Alum-ALM + BCG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 31, 2007)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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 and for normal ranges of laboratory values).
  • Presence of fever at the time of vaccination, i.e. body temperature (by mouth) > 37.5°C.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00429780
Other Study ID Numbers  ICMJE J/423/1058, 30/05/1385
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ali Khamesipour, Center for Research & Training in Skin Diseases & Leprosy
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE
  • Pasteur Institute of Iran, Tehran, Iran
  • Razi Vaccine and Serum Research Institute
  • Centre for Disease Control & Management, Ministry of Health & Medical Education
Investigators  ICMJE
Principal Investigator: Ali Khamesipour Center for Research and Training in Skin Disease and Leprosy,
PRS Account Tehran University of Medical Sciences
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP