Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – Testing efficacy or toxicity of a compound or composition
Reexamination Certificate
2005-08-17
2010-12-28
Swartz, Rodney P. (Department: 1645)
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
Testing efficacy or toxicity of a compound or composition
C424S009100, C424S184100, C424S234100, C424S243100, C424S244100, C424S256100, C424S257100, C424S260100, C424S263100
Reexamination Certificate
active
07858073
ABSTRACT:
There is described a method for selecting microbial isolates for use in oral killed vaccines against abnormal microbial colonization of mucosal surfaces by the microbes. The method comprises evaluating capacity of a plurality of different isolates of a microbe to activate antigen responsive cells to provide activation data for each microbial isolate, and the effectiveness of the isolates in reducing infection of a mucosal surface by the microbe to provide clearance data for each microbial isolate. An isolate, the activation data and clearance data for which correlate and is optimal for generating mucosal immunity against the microbe compared to the, or each, other of the isolates, or an isolate the activation data for which is optimal and a further isolate the clearance data for which is optimal, compared to the, or each, other of the isolates, respectively, is then selected for use in the vaccine. There is also described a method for providing an oral killed vaccine against abnormal microbial colonization of a mucosal surface, comprising evaluating the capacity of a plurality of different isolates of a microbe to induce expression of IL-10 and IL-12 in antigen responsive cells. At least one isolate is selected that induces optimal expression of IL-12 relative to IL-10 compared to the, or each, other of the isolates, respectively, for use in the vaccine.
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Gilbert et al., “Sieve analysis—methods for assessing from vaccine trial data how vaccine efficacy varies with genotypic and phenotypic pathogen variation”, Journal of Clinical Epidemiology, Jan. 2001, 68-85(18), vol. 54(1).
Hamers et al., “Virus neutralising antibodies against 22 bovine viral diarrhoea virus isolates in vaccinated calves”, Vet J., Jan. 2002; 61-7; vol. 163(1).
Hirano et al., “Intranasal immunization with a lipooligosaccharide-based conjugate vaccine from nontypeable Haemophilus influenzae enhances bacterial clearance in mouse nasopharynx”, FEMS Immunology & Medical Microbiology, 2003, 1-10, vol. 35 (1).
Clancy Robert
Comans Phillip
Pang Gerald
Hunter Technology Limited
Kaplan Gilman & Pergament LLP
Swartz Rodney P.
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