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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015101924604N1

Enrollment

1790

Registered

2017-04-20

Start date

2015-11-20

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 suspension of promastigotes or PBS were produced. A random list of codes for vials were prepared. Volunteers were inoculated intraderma

Placebo

Treatment - Drugs

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 promastigote

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

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; history of vaccination in the previous month; immune deficiency or immune suppression therapy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Immunity to cutaneous lesions. Timepoint: After vaccination. Method of measurement: Observation, taking sample and examination by routine methods with direct smear r.	—

Secondary

Measure	Time frame
Redness and induration at the site of injection,. Timepoint: after vaccination. Method of measurement: Measuring the size of induration by ruller,.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Daneshvar

Kerman University of Medical 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