title: Clinical study to assess the immunogenicity and safety of a recombinant Pseudomonas aeruginosa OprF-OprI vaccine in burn patients.
abstract: In a recent clinical trial we evaluated the safety and immunogenicity of a recombinant OprF-OprI vaccine consisting of the mature outer membrane protein I (OprI) and amino acids 190-342 of OprF of Pseudomonas aeruginosa in burn patients and compared the elicited antibodies with antibodies against tetanus as response to a simultaneous immunization given on the day of admission. Safety and immunogenicity of the vaccine had been tested before in healthy human volunteers as published in 1999. In this first clinical trial we immunized eight burn patients suffering from second or third degree burns involving between 35% and 55% of the body surface three times with 100 microg of the OprF-OprI vaccine. The vaccine was found to be very well tolerated. The patients did not show any serious side effects - and in particular no activation of the mediator cascade was observed. None of the subjects showed systemic P. aeruginosa infections during or after the treatment of their burns. The serological tests (ELISA) for detection of antibodies against P. aeruginosa and tetanus toxoid showed seroconversion for seven patients after inoculation. The data indicate that OprF-OprI can be a useful vaccine in the therapeutic management of burn injuries.
authors.affiliation: Surgical University Hospital, Hugstetterstr. 55, D-79106, Freiburg i.B., Germany. mansouri@ch11.ukl.uni-freiburg.de
authors.forename: Erfan
authors.initials: E
authors.lastname: Mansouri
authors.forename: Sigrid
authors.initials: S
authors.lastname: Blome-Eberwein
authors.forename: Josef
authors.initials: J
authors.lastname: Gabelsberger
authors.forename: Günter
authors.initials: G
authors.lastname: Germann
authors.forename: Bernd Ulrich
authors.initials: BU
authors.lastname: von Specht
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D001426:Bacterial Proteins / Q000235:genetics / Q000276:immunology*; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D002056:Burns / Q000150:complications / Q000628:therapy*; D005260:Female; D006801:Humans; D008074:Lipoproteins / Q000235:genetics / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D018272:Porins / Q000235:genetics / Q000276:immunology*; D011552:Pseudomonas Infections / Q000276:immunology / Q000517:prevention & control*; D011550:Pseudomonas aeruginosa / Q000276:immunology*; D016896:Treatment Outcome; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D001426:Bacterial Proteins; D001428:Bacterial Vaccines; D008074:Lipoproteins; D018272:Porins; D014614:Vaccines, Synthetic; C060507:outer membrane lipoprotein I, Bacteria