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Evaluation of randomised vaccine trial of single dose of the gentamicin-attenuated line of Leishmania major H-line against cutaneous leishmaniasis in west of Iran

Evaluations of 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 solution control group in west of Iran

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017022524604N2
Enrollment
5000
Registered
2017-04-06
Start date
2016-12-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous leishmaniasis. Cutaneous leishmaniasis

Interventions

Intervention 1: Sequentially numbered identical-looking vials of vaccine or phosphate buffer saline (PBS) were produced. A random list of codes for vials were prepared. Volunteers will be inoculated
Treatment - Drugs
Sequentially numbered identical-looking vials of vaccine or phosphate buffer saline (PBS) were produced. A random list of codes for vials were prepared. Volunteers will be inoculated intradermally PB
Sequentially numbered identical-looking vials of vaccine or placebo were produced, A random list of codes for vials were prepared. Volunteers will be vaccinated promastigotes suspension (0•1 mL) in t

Sponsors

Kerman University of Medical Sceinces
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 75 Years

Inclusion criteria

Inclusion 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; diabetic; history of vaccination in the previous month;history of autoimmunity, immune deficiency or immune suppression therapy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Immunity to cutaneous lesions. Timepoint: After vaccination. Method of measurement: Observation, examine by routine methods with.

Secondary

MeasureTime frame
Redness, induration and ulcer at the site of injection. Timepoint: After vaccination. Method of measurement: Measuring the size of induration.;Pain and itching site of injection, lymphadenopathy. Timepoint: After vaccination. Method of measurement: Observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Daneshvar

Kerman University ofMedical Sceinces

hamiddaneshvar@hotmail.com Hamid.Daneshvar@glasgow.ac.uk h.daneshvar@kmu.ac.ir+98 34 3222 3016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026