Repeated phase III randomized vaccine trial of single dose of the gentamicin-attenuated line of Leishmania major H-line against cutaneous leishmaniasis in in Vrznh in Isfahan Province and Zrghan in Fars Provinces.

Repeated phase III, blind randomized, clinical trial, multicenter atudy single dose clinical vaccine trial to evaluate the safety, immunogenicity and effececy of the gentamicin-attenuated line of Leishmania major H-line against cutaneous leishmaniasis in comparison with phosphate buffer saline control group in volunteers in Vrznh located in Isfahan Province and Zrghan located in Fars Province

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151019024604N3

Enrollment

5000

Registered

2018-11-08

Start date

2018-06-22

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

Leishmaniasis. Cutaneous leishmaniasis

Interventions

Intervention 1: Control group: Phosphate-buffered saline (PBS) [137 mM NaCl (Merck), 2.7 mM KCl (Merck), 10 mM Na2HPO4 (Merck), 1.5 mM KH2PO4 (Merck)

pH 7.4]. Intervention 2: Intervention group: Suspensions of stationary phase promastigotes of the attenuated line of L. major in PBS will be prepared and 0.1 ml of these suspensions will be injected i

Eligibility

Sex/Gender

All

Age

3 Years to 70 Years

Inclusion criteria

Inclusion criteria: Otherwise healthy; age: 3-75 years sign the consent form willingly to participate in this study.

Exclusion criteria

Exclusion criteria: History of leishmaniasis or any scar resembling cutaneous leishmaniasis pregnancy acute or chronic diseases history of allergy history of vaccination in the previous month immune deficiency or immune suppression therapy.

Design outcomes

Primary

Measure	Time frame
Immunity to cutaneous leishmaniasis. Timepoint: 4 weeks after immunization. Method of measurement: Observation lesion - Sampling from the lesion for laboratory diagnosis.	—

Secondary

Measure	Time frame
Redness; swelling of the vaccine injection site. Timepoint: 12-24 hours after vaccination. Method of measurement: Measuring redness and swelling.;Pain and itch the injection site of the vaccine and axillary lymphadenopathy. Timepoint: 12-24 hours after vaccination. Method of measurement: observation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Daneshvar

Kerman University of Medical Sciences

hamiddaneshvar@hotmail.com+98 34 3222 3016

Outcome results

None listed

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