Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429780
Status:
COMPLETED
Last Update Posted:
2009-11-18
First Post:
2007-01-31
Brief Title:
SafetyEfficacy Trial of Killed Leishmania Vaccine in Volunteers With Positive Response to Leishmanin LST0
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
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 LST0
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Development of a safe and effective vaccine against leishmaniasis started more than 10 years ago under WHOTDR 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 110th of normal dose of BCG was carried out in healthy volunteers from a non endemic area of Sudan The safetyimmunogenicity 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 110 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None