Journal
VACCINE
Volume 19, Issue 17-19, Pages 2291-2297Publisher
ELSEVIER SCI LTD
DOI: 10.1016/S0264-410X(00)00550-8
Keywords
mucosal vaccine; P. aeruginosa outer membrane proteins; human volunteers
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A hybrid protein [Met-Ala-(His)(6) OprF(190) (342)-OprI(21) (83)] consisting of the mature outer membrane protein I (OprI) and amino acids 190-342 of OprF of Pseudomonas aeruginosa was expressed in Escherichia coli and purified by Ni2+ chelate-affinity chromatography. After several studies in healthy volunteers, as well as in patients. had proven the tolerability and immunogenicity of the the OprF-OprI vaccine, after intra-muscular application, we developed an emulgel for intranasal immunization. For this purpose we combined a highly concentrated OprF-I with sodiumdodecylsulfate as vehicle and the gel matrix natriumlauryl sulfate. After safety and pyrogenicity evaluations in animals. eight healthy adult human volunteers received the OprF-I gel intranasally three times at 2-week intervals. The vaccination was well tolerated and no side effects were observed. An antibody induction (IgG and IgA) could be detected in the sera. These data support continued clinical investigation of the protection against infections in cystic fibrosis patients and patients prone to P. aeruginosa infections. (C) 2001 Elsevier Science Ltd. All rights reserved.
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