US 10,890,583 B2
Predictive value of Clostridium difficile-specific immune response for recurrence and disease outcome
Marie-Lise Gougeon, Antony (FR); Alban Le Monnier, Fontenay le Fleury (FR); Anne Collignon, Paris (FR); and Michel Robert Popoff, Clamart (FR)
Assigned to INSTITUT PASTEUR, Paris (FR); UNIVERSITE PARIS-SUD, Orsay (FR); CENTRE HOSPITALIER DE VERSAILLES, Le Chesnay (FR); and ASSISTANCE PUBLIQUE—HOPITAUX DE PARIS, Paris (FR)
Appl. No. 15/300,309
Filed by INSTITUT PASTEUR, Paris (FR); UNIVERSITE PARIS-SUD, Orsay (FR); CENTRE HOSPITALIER DE VERSAILLES, Le Chesnay (FR); and ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS, Paris (FR)
PCT Filed Apr. 1, 2015, PCT No. PCT/EP2015/057259
§ 371(c)(1), (2) Date Jul. 20, 2017,
PCT Pub. No. WO2015/150493, PCT Pub. Date Oct. 8, 2015.
Claims priority of provisional application 61/973,508, filed on Apr. 1, 2014.
Prior Publication US 2017/0212113 A1, Jul. 27, 2017
Int. Cl. G01N 33/569 (2006.01); A61K 39/08 (2006.01); G01N 33/564 (2006.01)
CPC G01N 33/56911 (2013.01) [A61K 39/08 (2013.01); G01N 33/564 (2013.01); G01N 33/56916 (2013.01); G01N 2333/33 (2013.01); G01N 2469/10 (2013.01); G01N 2469/20 (2013.01); G01N 2800/50 (2013.01)] 6 Claims
OG exemplary drawing
 
1. An in vitro method comprising:
a) providing a sample from a human subject diagnosed with Clostridium difficile-Associated Disease (CDAD) and at risk of developing a recurrent CDAD or severe form of CDAD;
b) quantitating in the sample IgG antibodies specifically binding the C. difficile toxin antigen TcdA, IgG antibodies specifically binding the C. difficile toxin antigen TcdB, IgG antibodies specifically binding the C. difficile antigen FliD, and IgM antibodies specifically binding the C. difficile antigen FliD; and
c) administering to the human subject a treatment or an immunogenic composition against C. difficile infection when at least 0.38 μg/mL of IgG antibodies specifically binding the C. difficile toxin antigen TcdA, at least 1.56 μg/mL IgG antibodies specifically binding the C. difficile toxin antigen TcdB, at least 1.86 μg/mL IgG antibodies specifically binding the C. difficile antigen FliD, and at least 0.65 μg/mL IgM antibodies specifically binding the C. difficile antigen FliD, are not quantitated in the sample; and
not administering to the human subject a treatment or an immunogenic composition against C. difficile infection when at least 0.38 μg/mL of IgG antibodies specifically binding the C. difficile toxin antigen TcdA, at least 1.56 μg/mL IgG antibodies specifically binding the C. difficile toxin antigen TcdB, at least 1.86 μg/mL IgG antibodies specifically binding the C. difficile antigen FliD, and at least 0.65 μg/mL IgM antibodies specifically binding the C. difficile antigen FliD, are quantitated in the sample.