Immunogenicity and safety of a tetravalent E. coli O-antigen bioconjugate vaccine in animal models

• Published in: Vaccine Vol. 34; no. 35; pp. 4152 - 4160
• Main Authors: van den Dobbelsteen, Germie P.J.M, Faé, Kellen C, Serroyen, Jan, van den Nieuwenhof, Ingrid M, Braun, Martin, Haeuptle, Micha A, Sirena, Dominique, Schneider, Joerg, Alaimo, Cristina, Lipowsky, Gerd, Gambillara-Fonck, Veronica, Wacker, Michael, Poolman, Jan T
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 29.07.2016; Elsevier Limited
• Subjects: Adjuvants, Immunologic - administration & dosage; ADP Ribose Transferases - immunology; Allergy and Immunology; Aluminum; Animal models; Animals; Antibiotics; Antibodies, Bacterial - blood; Antigens; Bacterial Toxins - immunology; Biosynthesis; Chromatography; Conjugate vaccine; Costs; Drug resistance; E coli; Escherichia coli; Escherichia coli Infections - prevention & control; Escherichia coli Vaccines - immunology; Exotoxins - immunology; Extra-intestinal pathogenic E. coli (ExPEC); Female; Immunization; Immunization, Secondary; Immunogenicity; Immunogenicity, Vaccine; Infections; Mice; Mice, Inbred ICR; Mortality; No-Observed-Adverse-Effect Level; O Antigens - immunology; Proteins; Pseudomonas aeruginosa; Pseudomonas aeruginosa Exotoxin A; Rabbits; Rats; Rats, Sprague-Dawley; Safety; Studies; Toxicity Tests; Vaccine; Vaccines; Vaccines, Conjugate - immunology; Virulence Factors - immunology; TBS; Conjugate vaccine; Escherichia coli; Vaccine; UTI; LPS; Extra-intestinal pathogenic E. coli (ExPEC); anion exchange chromatography; detoxified variant of Exotoxin A from Pseudomonas aeruginosa; Tris-buffered saline; Immunogenicity; TFF; tangential flow filtration; EPA; Safety; lipopolysaccharide; extra-intestinal pathogenic E. coli; urinary tract infection; AEC; ExPEC
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2016.06.067

Highlights • An ExPEC vaccine (O1, O2, O6, O25) was made using a novel bioconjugation process. • The 4-valent bioconjugated ExPEC vaccine was immunogenic in 3 animal models. • Antibody persistence and boostability were demonstrated in rats. • ExPEC-4V at full human dose was at the no observed adverse effect level in rats.