bivalent Pseudomonas aeruginosa flagella vaccine

The bivalent Pseudomonas aeruginosa flagella vaccine is a prophylactic biologic vaccine designed to prevent Pseudomonas aeruginosa pulmonary infection in patients with cystic fibrosis. The vaccine consists of bivalent flagellin proteins (flagella subtypes a and b, specifically subtypes a0a1a2 and b from strains 1210 and 5142, respectively) derived from P. aeruginosa, which target the bacterial flagella to elicit a protective immune response. Developed and sponsored by the Society for the Fight of Cystic Fibrosis (Gesellschaft zur Bekämpfung der Mukoviszidose e.V., Germany), the vaccine was evaluated in a completed Phase III double-blind, randomized, placebo-controlled multicenter trial in 483 European children and adolescents (ages 2–18) with cystic fibrosis and no prior P. aeruginosa colonization. Although the vaccine was well tolerated and induced high, long-lasting serum antiflagella IgG titers, it failed to meet its pre-specified primary efficacy threshold of 66% protection, showing only partial protection (34% against acute infection and 51% against chronic infection), leading to the termination of its clinical development.

Brand names

IMMUNOAerugen Berna Vaccine

Other names

bivalent P. aeruginosa flagella vaccinePseudomonas aeruginosa flagella vaccine