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Previous administration of an investigational C difficile vaccine or C difficile mAb therapy. Prior episode of CDI.. Receipt of blood products or immunoglobulins within 6 months before enrollment. Subjects who may be unable to respond to vaccination due to: Metastatic malignancy; or End-stage renal disease; or Any serious medical disorder likely to be fatal within the next 12 months; or Congenital or acquired immunodeficiency; or Receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
Known infection with human immunodeficiency virus HIV. Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components. Prior small- or large-bowel resection. Any condition or treatment resulting in frequent diarrhea. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. Lewis Research Inc. Lewis Research, Inc. De Salvo C. Bogota, D. Pribram I. Roznov pod Radhostem, Czechia, 61 Nemocnice Slany, p. Slany, Czechia, 01 Sarkamed s. Register for free and gain unlimited access to:. Continue Reading. Please login or register first to view this content. Open Next post in Clostridioides Difficile Close.
Close more info about Review of Clostridium difficile Vaccines in Development. Log in to continue reading this article. Surface-Associated Antigens as Vaccine Candidates Antibodies to surface protein antigens have also been associated with reduced CDI recurrence, although the correlation was not as statistically significant as in the case of an anti-toxin response.
Surface proteins Toxin-based vaccinations, although effective in preventing the disease manifestations, are likely unable to prevent C. Table 4. Summary of surface-associated antigens described in the literature. Crude SLP Mice, hamster i. Surface carbohydrates Polysaccharides coating the surface of bacterial pathogens represent an optimal target for eliciting carbohydrate specific antibodies. Conclusions and Perspectives The prevalence of CDI among elderly and immunocompromised individuals, together with the marked recurrence of the infection, poses substantial challenges to future C.
Acknowledgments We are grateful to Matthew J Bottomley for critical review of the manuscript. Notes References 1. Clostridium difficile infection in humans and animals, differences and similarities.
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Since the C difficile vaccine candidate met the criteria for futility, the study was terminated and clinical development of this vaccine candidate was stopped. Funding: Sanofi Pasteur.
Abstract Background: In the absence of a licensed vaccine, Clostridioides formerly Clostridium difficile infection represents a substantial health burden.
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