title: An assessment of thermal stability of Clostridium difficile toxoid formulations.
abstract: Strains of Clostridium difficile produce toxins A and B that can cause diarrhoea and pseudomembranous colitis. Currently, there is no preventative therapy for this infection but antibodies to the toxins provide protection, therefore a toxoid-based vaccine is needed. To evaluate thermal stability, a lyophilized and liquid formulation of toxoids A and B were stored at a range of temperatures for 5 weeks. Changes in toxoid structures and immune responses in an animal model before and after the incubation period were assessed. The structural integrity and the immune responses to liquid formulations were affected when stored at 56°C but the lyophilized formulation was thermally stable and same treatment did not result in significant loss of immunological responses when immunized in an animal model.
authors.affiliation: Bacteriology Divsion, NIBSC-HPA, South Mimms, Hertfordshire, UK.
authors.forename: Lorna E
authors.initials: LE
authors.lastname: Lancaster
authors.forename: Kevin
authors.initials: K
authors.lastname: Markey
authors.forename: Mei M
authors.initials: MM
authors.lastname: Ho
mesh_terms: D000818:Animals; D002522:Chlorocebus aethiops; D002850:Chromatography, Gel; D016360:Clostridioides difficile / Q000276:immunology*; D006224:Cricetinae; D004355:Drug Stability; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D007070:Immunoglobulin A / Q000097:blood; D008647:Mesocricetus; D009500:Neutralization Tests; D014121:Toxoids / Q000009:adverse effects / Q000737:chemistry* / Q000276:immunology; D014709:Vero Cells
chemical_list: D007070:Immunoglobulin A; D014121:Toxoids