Phase I, open clinical vaccine trial study, single dose to evaluate the safety, immunogenicity and efficacy of the gentamicin-attenuated line of Leishmania major H-line against Leishmania major wild-type in volunteers in Kerman
Determination of safety, immunogenicity and protective potency of attenuated Leishmania major H-line vaccine in volunteers
Design
The study was designed as Phase 1, open-label, placebo-controlled clinical trial initially on 27 healthy adult volunteers.
Settings and conduct
Clinical trial conducted in a non-endemic area of Kerman, Iran. A total 27 healthy adult volunteers were enrolled. The ethical principles set forth in the Declaration of Helsinki. Ethical approval was obtained from the Kerman University of Medical Sciences Ethical Committee in 2016 (Ethical code: IR.KMU. REC.1394-106). Written or oral Informed Consent Form (ICF) was obtained from all participants prior to enrollment. A negative LST was performed prior to vaccination. Subjects were screened for health status on medical history, vital signs, medical history, and laboratory examination results (including kidney, liver functions, diabetes and HIV). 0.1 ml vaccine at concentration of 30 × 106 cell/ml in PBS into their right deltoid area. A control injection of PBS was administered (i.d.) into deltoid area of their left arms. After 6 months, 25 subjects were challenged with L. major wild type (6 × 106 cell/ml) into the right forearm of each subject.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Healthy; age: 18-60 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.
Intervention groups
For evaluation protection of vaccine, Volunteers were vaccinated with the attenuated live Leishmania major vaccine
Main outcome variables
Determination safety and Immunogenicity of the attenuated Leishmania major
General information
Reason for update
Acronym
GALM
IRCT registration information
IRCT registration number:IRCT20151019024604N4
Registration date:2026-02-03, 1404/11/14
Registration timing:retrospective
Last update:2026-02-03, 1404/11/14
Update count:0
Registration date
2026-02-03, 1404/11/14
Registrant information
Name
Hamid Daneshvar
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3222 3016
Email address
hamid.daneshvar@glasgow.ac.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-06-09, 1394/03/19
Expected recruitment end date
2017-06-10, 1396/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase I, open clinical vaccine trial study, single dose to evaluate the safety, immunogenicity and efficacy of the gentamicin-attenuated line of Leishmania major H-line against Leishmania major wild-type in volunteers in Kerman
Public title
Safety, immunogenicity, and efficacy of a gentamicin-attenuated Leishmania major vaccine in an open-label clinical vaccine trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy male and female
Age 18-60 years old
Sign the consent form willingly to participate in this study
Exclusion criteria:
History or clinical signs (scars) of cutaneous leishmaniasis (CL)
Pregnancy
Acute or chronic disease history of allergic
History of vaccination in the previous month
Immune deficiency or immune suppression therapy
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
27
More than 1 sample in each individual
Number of samples in each individual:
27
27 volunteers
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Kerman University of Medical Sciences and Health Services
Street address
Jahad Blvd. Ebn Sina Avenue
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2015-05-27, 1394/03/06
Ethics committee reference number
IR.KMU. REC.1394.106
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
Evaluation safety of vaccine
Timepoint
Usually after intervention for 2 years
Method of measurement
Measuring any adverse events such as redness, induration and lesion. Measuring hematological and biochemical parameters for evaluation liver and kidney functions.
Secondary outcomes
1
Description
The attenuated line of L. major vaccine activated cellular immunity which induced 92% protective efficacy against clinical infection
Timepoint
Usually reached 4 weeks after immunization
Method of measurement
Immunological assessments: Measuring anti-Leishmania IgG prior and post vaccination, Leishmanin Skin Test, gene expression cytokine (IL-12, IFN-γ) and toll like receptor (TLR2,4,9).Leishmanization (challenge with wild type Leishmania major), for investigation the ability of vaccine to protection, and measuring size of lesion, if developed.
Intervention groups
1
Description
The intervention group: Promastigotes of the attenuated line of Leishmania major were grown in RPMI-1640 medium (Sigma-Aldrich) supplemented with 10% FBS (Labtech International). Cells were harvested, washed with Phosphate-Buffered Saline (PBS), and re-suspended to 20 million cell/ml in PBS containing 7.5% glycerol and glycose. The suspension was dispersed in 1 ml volume aliquots, which cryopreserved using controlled slow-freezing protocol and maintained in liquid nitrogen until the time of use. For inoculation, vials were rapidly thawed and used for intradermal (i.d.) injection. The subjects received a single intradermal injection of 0.1 ml suspensions of cells at concentration of 30 million cell/ml in PBS into their right deltoid area.
Category
Prevention
2
Description
Control group: The subjects received intradermal injection of 0.1 ml sterile phosphate-buffered saline (PBS) into their left deltoid area of their left arms.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Medical University
Full name of responsible person
Hamid Daneshvar
Street address
Jahad Blvd. Ebn Sina Avenueا
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
hdaneshvar5550@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Hamid Sharifi
Street address
Jahad Blvd. Ebn Sina Avenue
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
hdaneshvar5550@gmail.com
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 Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Daneshvar
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Kerman Medical University
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3222 3016
Email
hdaneshvar5550@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Daneshvar
Position
Associate professor,
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Kerman Medical University
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
0098 34 34 32223016
Email
hdaneshvar5550@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Daneshvar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Kerman Medical University
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 4222 3016
Email
hdaneshvar5550@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Following details are available:
Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report
When the data will become available and for how long
Data are ready after submission paper
To whom data/document is available
This available for people working in academic institutions
Under which criteria data/document could be used
After publishing data
From where data/document is obtainable
After submission in Journal
What processes are involved for a request to access data/document
All details of study will be published.
Comments
The Phase 1 clinical trial is being registered retrospectively to meet journal publication requirements and to ensure complete public documentation of all phases of the vaccine’s clinical development.
Although the Phase 1 study was conducted earlier, the subsequent Phase 2 and Phase 3 clinical trials for this vaccine were prospectively registered, completed, and finalized approximately two years ago. Registering the Phase 1 trial at this time ensures transparency and consistency across all trial phases and aligns with WHO and ICMJE recommendations for trial registration