Drug intelligence / Profile preview

alum + autoclaved Leishmania major

Development stage
Phase 3
Lead developer
Razi Vaccine & Serum Research Institute
Modality
Vaccines & Immunotherapeutics
Administration
Intradermal, Intramuscular
01

Overview

Alum + autoclaved Leishmania major (ALM) is a first-generation candidate vaccine and immunotherapeutic agent developed primarily for the prevention and treatment of cutaneous leishmaniasis. It consists of killed (autoclaved) *Leishmania major* promastigotes, which serve as a complex source of parasite antigens, adsorbed onto an aluminium hydroxide (alum) adjuvant. The vaccine is designed to stimulate a T-cell mediated immune response against the *Leishmania* parasite. In clinical trials, it has been investigated both as a prophylactic vaccine to prevent infection and as an adjunct to chemotherapy (immunotherapy) to accelerate the healing of chronic lesions. While it has demonstrated safety and a degree of immunogenicity in various Phase 2 and Phase 3 trials, particularly in endemic regions such as Iran, Sudan, and Pakistan, its efficacy has been variable, often necessitating multiple doses or combination with other agents like BCG to enhance Th1-type immunity.

Other names
autoclaved Leishmania major vaccine with alum adjuvantalum-precipitated autoclaved Leishmania majorkilled Leishmania major vaccine with alumALM adjuvant vaccine
02

Targets

pMHC-I (Peptide–MHC class I complex)Leishmania major peptide-MHC class II complexNLRP3 (Nod-like receptor family pyrin domain-containing protein 3)γδ TCR (T-cell receptor)

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