Safety, immunogenicity, and efficacy of a gentamicin-attenuated Leishmania major vaccine in an open-label clinical vaccine trial

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151019024604N4

Enrollment

Registered

2026-02-03

Start date

2015-06-09

Completion date

Unknown

Last updated

2026-06-01

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: 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

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy male and female Age 18-60 years old Sign the consent form willingly to participate in this study

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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-?) 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.	—

Measure

Time frame

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-?) 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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Daneshvar

Kerman University of Medical Sciences

hdaneshvar5550@gmail.com+98 34 3222 3016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026