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The Pseudomonas aeruginosa bivalent flagella vaccine (brand name Aerugen) is a prophylactic protein subunit vaccine developed to prevent Pseudomonas aeruginosa lung infections in patients with cystic fibrosis. Developed by Berna Biotech in collaboration with the Society for the Fight of Cystic Fibrosis (Germany), the vaccine consists of purified flagellin proteins from both P. aeruginosa flagella serotypes a and b. Its mechanism of action involves the induction of high and long-lasting serum antiflagella IgG antibody titers, which inhibit bacterial motility and colonization. In a Phase III double-blind, randomized, placebo-controlled multicenter trial involving 483 European cystic fibrosis patients, vaccinated individuals showed a significantly reduced risk of chronic P. aeruginosa infection compared to those receiving a placebo. Despite these results, the vaccine has not received broad regulatory approval and development appears to have stalled.
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