US2020113991A1PendingUtilityA1

Compositions and Methods for Immunizing Against C. Difficile

63
Assignee: SANOFI PASTEUR INCPriority: Jun 14, 2013Filed: Oct 21, 2019Published: Apr 16, 2020
Est. expiryJun 14, 2033(~6.9 yrs left)· nominal 20-yr term from priority
A61K 2039/55511A61K 2039/55A61P 31/04A61K 2039/545A61K 39/08A61P 37/04A61P 31/00A61P 43/00
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Claims

Abstract

This disclosure relates to methods for eliciting an immune response against C. difficile toxin A and toxin Bin an adult human subject. The subject may be at risk for a primary symptomatic C. difficile infection. In some embodiments, a method is for eliciting an immune response against C. difficile toxin A and toxin B in an adult human subject at risk for a primary symptomatic C. difficile infection, and comprises administering to the subject a composition comprising C. difficile toxoid A and toxoid B at least three times, each administration being about seven days apart.

Claims

exact text as granted — not AI-modified
1 - 37 . (canceled) 
     
     
         38 . A method for eliciting an immune response against  C. difficile  toxin A and  C. difficile  toxin B in a human subject, the method comprising administering to the subject a composition comprising  C. difficile  toxoid A and  C. difficile  toxoid B at a purity of about 90% or higher (w/w) at least three times, each administration being at least about seven days apart; optionally wherein the first administration is separated from the second administration by about 30 days, and the third administration is separated from the first administration by about 180 days. 
     
     
         39 . A composition comprising about 100 μg of  C. difficile  toxoid A and  C. difficile  toxoid B, optionally at an approximate ratio of 3:2; and, an adjuvant. 
     
     
         40 . A kit comprising: a container comprising one or more doses of  C. difficile  toxoid A and  C. difficile  toxoid B; and, instructions for administering said doses to elicit an immune response against  C. difficile  toxin A and  C. difficile  toxin B in a human subject.

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