LepVax: Advancing Science, Building Partnerships, and Transforming Leprosy Control

LepVax: Advancing Science, Building Partnerships, and Transforming Leprosy Control

 

Dr Veronica Pereira, Senior Researcher in Public Health, 
Fundação Oswaldo Cruz (Fiocruz), Brazil

LepVax is a groundbreaking leprosy vaccine developed over two decades, utilizing reverse vaccinology to create the LEP-F1 recombinant protein, which consists of four Mycobacterium leprae antigens. It combines LEP-F1 with glucopyranosyl lipid A (GLA) in a stable emulsion called GLA-SE. Despite challenges in preclinical trials using the armadillo model, LepVax demonstrated efficacy and showed safety and immunogenicity in U.S. participants. The next step is a Phase 1b study in Rio de Janeiro, Brazil, to further assess the vaccine's safety and immunogenicity in 54 BCG-vaccinated, healthy adults.

This double-blind, randomized, placebo-controlled trial will test two doses of LEP-F1 (2 µg and 10 µg) alongside a fixed dose of GLA-SE. Future phases will explore the vaccine's therapeutic potential for newly diagnosed leprosy patients and its efficacy. This project involves collaboration among various organizations, including the Hope Rises International (formerly American Leprosy Mission), the Access to Advanced Health Institute (AAHI), and the Oswaldo Cruz Foundation (FIOCRUZ), emphasizing community engagement and ethical considerations in vaccine research.