Protocol summary

Summary
A live attenuated line of Leishmania major (L. major H-line) has been established by culturing promastigotes in vitro under gentamicin pressure. Aim: This study was designed to investigate the safety and protection of the attenuated line of Leishmania major vaccine. A randomised, double-blind, controlled trial with 2-year follow-up after the administration a single dose of vaccine. The present study was carried out in some endemic areas of cities of Sabzevar and Sarakhs, located Razavi Khorasan Province in east of Iran, which have a population of about 230 000 and 35 000 respectively. A total of 1790 healthy males and females aged: 3-75 years old volunteers were received the attenuated line vaccine or placebo. Interventions: All volunteers or child’s parents were understood and the consent form willingly to participate in the study were signed by volunteers or child’s parents (under 18 year). Sequentially numbered identical-looking vials of vaccine or PBS were produced. A random list of codes for vials were prepared. Volunteers were inoculated intradermally 0•1 mL of the attenuated of L. major or PBS (0.1 ml) in the deltoid area of their right hands. The codes were kept sealed until the end of the 2-year follow-up..Inclusion and exclusion criteria: Inclusion criteria: Otherwise healthy, exclusion criteria: History of leishmaniasis or any scar resembling cutaneous leishmaniasis. Primary outcome: Immunity to cutaneous leishmaniasis. During the follow-up period 24 month, suspected cutaneous lesions lasting for more than 4 weeks have been examined by routine laboratory methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015101924604N1
Registration date: 2017-04-20, 1396/01/31
Registration timing: na

Last update:
Update count: 0
Registration date
2017-04-20, 1396/01/31
Registrant information
Name
Hamid Daneshvar
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 343222016
Email address
hamid.daneshvar@glasgow.ac.uk
Recruitment status
Not enough for processing
Funding source
Kerman University of Medical Sceinces
Expected recruitment start date
2015-11-20, 1394/08/29
Expected recruitment end date
2007-11-20, 1386/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluations of phase II double blind randomized controlled clinical trial, single dose of the gentamicin-attenuated line of Leishmania major H-line vaccine against cutaneous leishmaniasis in comparison with phosphate buffer saline control group in Sabzevar and Sarakhs located in Razavi Khorasan Province in east of Iran
Public title
Evaluation of phase II randomised vaccine trial of single dose of the gentamicin-attenuated line of Leishmania major H-line against cutaneous leishmaniasis in Sabzevar and Sarakhs in east of Iran
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion and exclusion criteria: 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; pregnant; acute or chronic disease; history of allergic; history of vaccination in the previous month; immune deficiency or immune suppression therapy.
Age
From 3 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 1790
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University of Medical Sceinces
Street address
Kerman University of Medical Sceinces
City
Kerman
Postal code
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
IR.KMU.REC.1394.244

Health conditions studied

1

Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis

Primary outcomes

1

Description
Immunity to cutaneous lesions
Timepoint
After vaccination
Method of measurement
Observation, taking sample and examination by routine methods with direct smear r

Secondary outcomes

1

Description
redness and induration at the site of injection,
Timepoint
after vaccination
Method of measurement
Measuring the size of induration by ruller,

Intervention groups

1

Description
Sequentially numbered identical-looking vials of suspension of promastigotes or PBS were produced. A random list of codes for vials were prepared. Volunteers were inoculated intradermally promastigotes (0.1 ml) in the deltoid area of their right hands.
Category
Placebo

2

Description
Sequentially numbered identical-looking vials of vaccine or phosphate buffer saline (PBS) were produced. A random list of codes for vials were prepared. Volunteers were inoculated intradermally PBS (0.1 ml) in the deltoid area of their right hands.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman University of Medical Sceinces
Full name of responsible person
Dr Hamid Daneshvar
Street address
Medical faculty Kernan University of Medical Sceinces
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sceinces
Full name of responsible person
Dr Pardakhti
Street address
Kerman University of Medical Sceinces
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sceinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sceinces
Full name of responsible person
Hamid Daneshvar
Position
Immunoparasitology/ PI
Other areas of specialty/work
Street address
Afzli pour Medical School
City
Kerman
Postal code
Phone
+98 34 3222 3016
Fax
Email
hamiddaneshvar@hotmail.com و Hamid.Daneshvar@glasgow.ac.uk و h.daneshvar@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Kerman University
Full name of responsible person
Hamid Daneshvar
Position
Immunoparasitology/ PhD
Other areas of specialty/work
Street address
Afzli pour Medical School, Kerman University of Kerman University
City
Kerman
Postal code
Phone
+98 34 3222 3016
Fax
Email
hamiddaneshvar@hotmail.com و Hamid.Saneshvar@glasgow.ac.uk و h.daneshvar@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sceinces
Full name of responsible person
Hamid Daneshvar
Position
PhD Immunoparasitology/ PI
Other areas of specialty/work
Street address
Afzli pour Medical Schoolm, Kerman University of Kerman University
City
Kerman
Postal code
Phone
+98 34 3222 3016
Fax
Email
hamiddaneshvar@hotmail.com و Hamid.Saneshvar@glasgow.ac.uk و h.daneshvar@kmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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