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Infection and Immunity, March 1999, p. 1461-1470, Vol. 67, No. 3
0019-9567/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Safety and Immunogenicity of a Pseudomonas aeruginosa Hybrid Outer Membrane Protein F-I Vaccine in Human Volunteers

Erfan Mansouri,1 Josef Gabelsberger,2 Bernhard Knapp,3 Erika Hundt,3 Uwe Lenz,3 Klaus-Dieter Hungerer,3 Harry E. Gilleland Jr.,4 John Staczek,4 Horst Domdey,2 and Bernd-Ulrich von Specht1,*

Chirurgische Universitätsklinik der Universität Freiburg, Freiburg,1 Institut für Biochemie-Genzentrum-der LMU München, Munich,2 and Chiron Behring GmbH, Marburg,3 Germany, and Department of Microbiology and Immunology, School of Medicine, Louisiana State University Medical Center, Shreveport, Louisiana4

Received 26 August 1998/Returned for modification 5 October 1998/Accepted 8 December 1998

A hybrid protein [Met-Ala-(His)6OprF190-342-OprI21-83] consisting of the mature outer membrane protein I (OprI) and amino acids 190 to 342 of OprF of Pseudomonas aeruginosa was expressed in Escherichia coli and purified by Ni2+ chelate-affinity chromatography. After safety and pyrogenicity evaluations in animals, four groups of eight adult human volunteers were vaccinated intramuscularly three times at 4-week intervals and revaccinated 6 months later with either 500, 100, 50, or 20 µg of OprF-OprI adsorbed onto A1(OH)3. All vaccinations were well tolerated. After the first vaccination, a significant rise of antibody titers against P. aeruginosa OprF and OprI was measured in volunteers receiving the 100- or the 500-µg dose. After the second vaccination, significant antibody titers were measured for all groups. Elevated antibody titers against OprF and OprI could still be measured 6 months after the third vaccination. The capacity of the elicited antibodies to promote complement binding and opsonization could be demonstrated by a C1q-binding assay and by the in vitro opsonophagocytic uptake of P. aeruginosa bacteria. These data support the continued development of an OprF-OprI vaccine for use in humans.

* Corresponding author. Mailing address: Chirurgische Universitätsklinik, Chirurgische Forschung, Hugstetterstr. 55, D-79106 Freiburg i. Brsg., Germany. Phone: 49 761 270-2575. Fax: 49 761 270-2579. E-mail: specht{at}sun1.ruf.uni-freiburg.de.

Infection and Immunity, March 1999, p. 1461-1470, Vol. 67, No. 3
0019-9567/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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Copyright © 1999 by the American Society for Microbiology. All rights reserved.