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Safety and immunogenicity of an intranasal Pseudomonas aeruginosa hybrid outer membrane protein F-I vaccine in human volunteers.

Abstract：

: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 Ni(2+) 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 sodium dodecylsulfate 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.

journal_name

Vaccine

journal_title

Vaccine

authors

Larbig M,Mansouri E,Freihorst J,Tümmler B,Köhler G,Domdey H,Knapp B,Hungerer KD,Hundt E,Gabelsberger J,von Specht BU

doi

10.1016/s0264-410x(00)00550-8

subject

Has Abstract

pub_date

2001-03-21 00:00:00

pages

2291-7

issue

17-19

eissn

0264-410X

issn

1873-2518

pii

S0264410X00005508

journal_volume

19

pub_type

临床试验,杂志文章

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