Clinical study to assess the immunogenicity and safety of a recombinant Pseudomonas aeruginosa OprF-OprI vaccine in burn patients

• Published in: FEMS immunology and medical microbiology 2003-07, Vol.37 (2), p.161-166
• Main Authors: Mansouri, Erfan, Blome-Eberwein, Sigrid, Gabelsberger, Josef, Germann, Günter, von Specht, Bernd-Ulrich
• Format: Article
• Language: English
• Subjects: Adult; Antibodies, Bacterial - blood; Bacterial Proteins - genetics; Bacterial Proteins - immunology; Bacterial Vaccines - administration & dosage; Bacterial Vaccines - adverse effects; Bacterial Vaccines - immunology; Bacteriology; Biological and medical sciences; Burn; Burns - complications; Burns - therapy; Female; Fundamental and applied biological sciences. Psychology; Humans; Infectious disease; Lipoproteins - genetics; Lipoproteins - immunology; Male; Microbiology; Middle Aged; Outer membrane protein; Porins - genetics; Porins - immunology; Pseudomonas aeruginosa; Pseudomonas aeruginosa - immunology; Pseudomonas Infections - immunology; Pseudomonas Infections - prevention & control; Treatment Outcome; Vaccination; Vaccine; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies; Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology
• ISSN: 0928-8244; 1574-695X
• DOI: 10.1016/S0928-8244(03)00072-5

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 μg 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.