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The autoclaved Leishmania major vaccine (Alum/ALM vaccine) is a first-generation, whole killed-parasite immunotherapeutic agent consisting of autoclaved Leishmania major promastigotes precipitated with aluminium hydroxide (alum) as an adjuvant. It is typically co-administered with Bacillus Calmette-Guérin (BCG) to enhance immunogenicity. Developed under the sponsorship of the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), the vaccine is designed to stimulate host cell-mediated immunity, particularly interferon-gamma (IFN-g) production, against Leishmania antigens. While it demonstrated limited prophylactic efficacy against visceral leishmaniasis (VL) and cutaneous leishmaniasis (CL) in large-scale field trials, it has shown significant promise as an adjunct immunotherapeutic agent. In clinical trials, combining the Alum-ALM + BCG vaccine with sodium stibogluconate (SSG) significantly improved cure rates in patients with persistent post-kala-azar dermal leishmaniasis (PKDL) compared to SSG chemotherapy alone.
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