A randomized, placebo-controlled phase I study assessing the safety and immunogenicity of a Pseudomonas aeruginosa hybrid outer membrane protein OprF/I vaccine (IC43) in healthy volunteers

References

• Kerr KG, Snelling AM. Pseudomonas aeruginosa: a formidable and ever-present adversary. J Hosp Infect 2009; 73:338 - 44; http://dx.doi.org/10.1016/j.jhin.2009.04.020; PMID: 19699552
   PubMed Web of Science ®Google Scholar
• Rello J, Ausina V, Ricart M, Puzo C, Quintana E, Net A, Prats G. Risk factors for infection by Pseudomonas aeruginosa in patients with ventilator-associated pneumonia. Intensive Care Med 1994; 20:193 - 8; http://dx.doi.org/10.1007/BF01704699; PMID: 8014285
   PubMed Web of Science ®Google Scholar
• Parkins MD, Gregson DB, Pitout JD, Ross T, Laupland KB. Population-based study of the epidemiology and the risk factors for Pseudomonas aeruginosa bloodstream infection. Infection 2010; 38:25 - 32; http://dx.doi.org/10.1007/s15010-009-9145-9; PMID: 20012908
   PubMed Web of Science ®Google Scholar
• National Nosocomial Infections Surveillance System. National Nosocomial Infections Surveillance (NNIS) system report, data summary from January 1992 through June 2004, issued October 2004. Am J Infect Control 2004; 32:470 - 85; http://dx.doi.org/10.1016/j.ajic.2004.10.001; PMID: 15573054
   PubMed Web of Science ®Google Scholar
• Döring G, Meisner C, Stern M, Flagella Vaccine Trial Study Group. A double-blind randomized placebo-controlled phase III study of a Pseudomonas aeruginosa flagella vaccine in cystic fibrosis patients. Proc Natl Acad Sci U S A 2007; 104:11020 - 5; http://dx.doi.org/10.1073/pnas.0702403104; PMID: 17585011
   PubMed Web of Science ®Google Scholar
• Parameswaran GI, Sethi S. Pseudomonas infection in chronic obstructive pulmonary disease. Future Microbiol 2012; 7:1129 - 32; http://dx.doi.org/10.2217/fmb.12.88; PMID: 23030418
   PubMed Web of Science ®Google Scholar
• Linden PK, Kusne S, Coley K, et al. Use of parenteral colistin for the treatment of serious infection due to antimicrobialresistant Pseudomonas aeruginosa. Clin Infect Dis 2003; 37:154 - 60; http://dx.doi.org/10.1086/379611
   PubMed Web of Science ®Google Scholar
• Pier G. Application of vaccine technology to prevention of Pseudomonas aeruginosa infections. Expert Rev Vaccines 2005; 4:645 - 56; http://dx.doi.org/10.1586/14760584.4.5.645; PMID: 16221066
   PubMed Web of Science ®Google Scholar
• Bumann D, Behre C, Behre K, Herz S, Gewecke B, Gessner JE, von Specht BU, Baumann U. Systemic, nasal and oral live vaccines against Pseudomonas aeruginosa: a clinical trial of immunogenicity in lower airways of human volunteers. Vaccine 2010; 28:707 - 13; http://dx.doi.org/10.1016/j.vaccine.2009.10.080; PMID: 19887136
   PubMed Web of Science ®Google Scholar
• von Specht BU, Lücking HC, Blum B, Schmitt A, Hungerer KD, Domdey H. Safety and immunogenicity of a Pseudomonas aeruginosa outer membrane protein I vaccine in human volunteers. Vaccine 1996; 14:1111 - 7; http://dx.doi.org/10.1016/0264-410X(96)00054-0; PMID: 8911006
   PubMed Web of Science ®Google Scholar
• Jones RJ, Roe EA, Gupta JL. Controlled trials of a polyvalent pseudomonas vaccine in burns. Lancet 1979; 2:977 - 82; http://dx.doi.org/10.1016/S0140-6736(79)92559-5; PMID: 91774
   PubMed Web of Science ®Google Scholar
• Kim DK, Kim JJ, Kim JH, Woo YM, Kim S, Yoon DW, Choi CS, Kim I, Park WJ, Lee N, et al. Comparison of two immunization schedules for a Pseudomonas aeruginosa outer membrane proteins vaccine in burn patients. Vaccine 2000; 19:1274 - 83; http://dx.doi.org/10.1016/S0264-410X(00)00235-8; PMID: 11137267
   PubMed Web of Science ®Google Scholar
• Cripps AW, Peek K, Dunkley M, Vento K, Marjason JK, McIntyre ME, Sizer P, Croft D, Sedlak-Weinstein L. Safety and immunogenicity of an oral inactivated whole-cell pseudomonas aeruginosa vaccine administered to healthy human subjects. Infect Immun 2006; 74:968 - 74; http://dx.doi.org/10.1128/IAI.74.2.968-974.2006; PMID: 16428742
   PubMed Web of Science ®Google Scholar
• Derhaschnig U, Bergmair D, Marsik C, Schlifke I, Wijdenes J, Jilma B. Effect of interleukin-6 blockade on tissue factor-induced coagulation in human endotoxemia. Crit Care Med 2004; 32:1136 - 40; http://dx.doi.org/10.1097/01.CCM.0000126265.08175.BE; PMID: 15190963
   PubMed Web of Science ®Google Scholar
• Mutharia LM, Hancock RE. Surface localization of Pseudomonas aeruginosa outer membrane porin protein F by using monoclonal antibodies. Infect Immun 1983; 42:1027 - 33; PMID: 6315589
   PubMed Web of Science ®Google Scholar
• Qiu D, Eisinger VM, Head NE, Pier GB, Yu HD. ClpXP proteases positively regulate alginate overexpression and mucoid conversion in Pseudomonas aeruginosa. Microbiology 2008; 154:2119 - 30; http://dx.doi.org/10.1099/mic.0.2008/017368-0; PMID: 18599839
   PubMed Web of Science ®Google Scholar
• Mansouri E, Gabelsberger J, Knapp B, Hundt E, Lenz U, Hungerer KD, Gilleland HE Jr., Staczek J, Domdey H, von Specht BU. Safety and immunogenicity of a Pseudomonas aeruginosa hybrid outer membrane protein F-I vaccine in human volunteers. Infect Immun 1999; 67:1461 - 70; PMID: 10024596
   PubMed Web of Science ®Google Scholar
• Larbig M, Mansouri E, Freihorst J, Tümmler B, Köhler G, Domdey H, Knapp B, Hungerer KD, Hundt E, Gabelsberger J, et al. Safety and immunogenicity of an intranasal Pseudomonas aeruginosa hybrid outer membrane protein F-I vaccine in human volunteers. Vaccine 2001; 19:2291 - 7; http://dx.doi.org/10.1016/S0264-410X(00)00550-8; PMID: 11257350
   PubMed Web of Science ®Google Scholar
• Baumann U, Gocke K, Hagemann H, Freihorst J, von Specht BU. Mucosal immune response after nasal and systemic vaccination with a recombinant outer membrane protein F and I of Pseudomonas aeruginosa in healthy volunteers. [abstract] Pediatr Pulmonol Suppl 2002; 34:Suppl 24 275
   Google Scholar
• Jang IJ, Kim IS, Park WJ, Yoo KS, Yim DS, Kim HK, Shin SG, Chang WH, Lee NG, Jung SB, et al. Human immune response to a Pseudomonas aeruginosa outer membrane protein vaccine. Vaccine 1999; 17:158 - 68; http://dx.doi.org/10.1016/S0264-410X(98)00159-5; PMID: 9987150
   PubMed Web of Science ®Google Scholar
• Keitel WA, Dekker CL, Mink C, Campbell JD, Edwards KM, Patel SM, Ho DY, Talbot HK, Guo K, Noah DL, et al. Safety and immunogenicity of inactivated, Vero cell culture-derived whole virus influenza A/H5N1 vaccine given alone or with aluminum hydroxide adjuvant in healthy adults. Vaccine 2009; 27:6642 - 8; http://dx.doi.org/10.1016/j.vaccine.2009.03.015; PMID: 19773098
   PubMed Web of Science ®Google Scholar
• Rupprecht CE, Briggs D, Brown CM, Franka R, Katz SL, Kerr HD, Lett S, Levis R, Meltzer MI, Schaffner W, et al. Evidence for a 4-dose vaccine schedule for human rabies post-exposure prophylaxis in previously non-vaccinated individuals. Vaccine 2009; 27:7141 - 8; http://dx.doi.org/10.1016/j.vaccine.2009.09.029; PMID: 19925944
   PubMed Web of Science ®Google Scholar
• Vodopija I, Baklaić Z, Vodopija R. Rabipur: a reliable vaccine for rabies protection. Vaccine 1999; 17:1739 - 41; http://dx.doi.org/10.1016/S0264-410X(98)00427-7; PMID: 10194832
   PubMed Web of Science ®Google Scholar
• Wasi C, Chaiprasithikul P, Auewarakul P, Puthavathana P, Thongcharoen P, Trishnananda M. The abbreviated 2-1-1 schedule of purified chick embryo cell rabies vaccination for rabies postexposure treatment. Southeast Asian J Trop Med Public Health 1993; 24:461 - 6; PMID: 8160053
   PubMedGoogle Scholar
• Kitphati R, Pooruk P, Lerdsamran H, Poosuwan S, Louisirirotchanakul S, Auewarakul P, Chokphaibulkit K, Noisumdaeng P, Sawanpanyalert P, Puthavathana P. Kinetics and longevity of antibody response to influenza A H5N1 virus infection in humans. Clin Vaccine Immunol 2009; 16:978 - 81; http://dx.doi.org/10.1128/CVI.00062-09; PMID: 19458206
   PubMed Web of Science ®Google Scholar
• Tagliabue A, Rappuoli R. Vaccine adjuvants: the dream becomes real. Hum Vaccin 2008; 4:347 - 9; http://dx.doi.org/10.4161/hv.4.5.6438; PMID: 18682690
   PubMed Web of Science ®Google Scholar
• Mansouri E, Blome-Eberwein S, Gabelsberger J, Germann G, von Specht BU. Clinical study to assess the immunogenicity and safety of a recombinant Pseudomonas aeruginosa OprF-OprI vaccine in burn patients. FEMS Immunol Med Microbiol 2003; 37:161 - 6; http://dx.doi.org/10.1016/S0928-8244(03)00072-5; PMID: 12832120
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices (ACIP): use of vaccines and immune globulins for persons with altered immunocompetence. MMWR Recomm Rep 1993; 42:RR-4 1 - 18; PMID: 8474421
   PubMedGoogle Scholar
• Committee for Medicinal Products for Human Use (CHMP). Guidance on clinical evaluation of new vaccines. October 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003870.pdf
   Google Scholar
• Goldblatt D. Simple solid phase assays of avidity. Immunochemistry 2, A Practical Approach, Oxford University Press 1997.
   Google Scholar
• Crotty S, Aubert RD, Glidewell J, Ahmed R. Tracking human antigen-specific memory B cells: a sensitive and generalized ELISPOT system. J Immunol Methods 2004; 286:111 - 22; http://dx.doi.org/10.1016/j.jim.2003.12.015; PMID: 15087226
   PubMed Web of Science ®Google Scholar
• Altman D, Machin D, Bryant T, Gardner M. Statistics with confidence. 2nd ed. Bristol: BMJ Books; 2000.
   Google Scholar
• Jones RL, Froeschle JE, Atmar RL, Matthews JS, Sanders R, Pardalos J, Moeller L, Chin JE, Famula M, Briggs DJ, et al. Immunogenicity, safety and lot consistency in adults of a chromatographically purified Vero-cell rabies vaccine: a randomized, double-blind trial with human diploid cell rabies vaccine. Vaccine 2001; 19:4635 - 43; http://dx.doi.org/10.1016/S0264-410X(01)00238-9; PMID: 11535311
   PubMed Web of Science ®Google Scholar