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The example below shows a use-case of undesired cellular immune response toward a protein therapeutic delivered through the viral vector technology.
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Rows 1-2: | Show the measurement of interferon gamma (ISMSCBCE) cytokine-secreting T cells (ISTEST) at baseline either with no stimulation (row 1) or stimulated with the RSV-antigen (row 2in response to stimulation by the viral vector and the therapeutic peptide (translated from the transgene delivered by the vector) in ISCNDAGT, respectively, prior to vaccinationstudy treatment. | Rows 3-4: | Show the measurement of interferon gamma gamma (ISMSCBCE) cytokine-secreting T cells (ISTEST) 3 weeks after vaccination and restimulation in vitro with the RSV-antigen (row 4at baseline in response to stimulation by the viral vector and the therapeutic peptide (translated from the transgene delivered by the vector) in ISCNDAGT and no stimulation (row 3), respectively, after study treatment. |
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Row | STUDYID | DOMAIN | | ISSEQ | ISREFID | ISTESTCD | ISTEST | ISMSCBCE | ISTSTCND | ISCNDAGT | ISCAT | ISSCAT | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | VISITNUM | VISIT | ISDTC |
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1 | RSV1230 | IS | RSV1230-011 | 1 | 13668 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | HUMAN ADENOVIRUS TYPE 26 VECTOR | VECTOR-INDUCED IMMUNOGENICITY | CELLULAR IMMUNITY | 5.1 | SFC/10^6 PBMC | 5.1 | 5.1 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 1 | BASELINE | 2017-05-27 | 2 | RSV1230 | IS | RSV1230-011 | 2 | 13668 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | THERAPEUTIC PEPTIDE | ANTIDRUG IMMUNOGENICITY or ANTIDRUG T CELL-MEDIATED IMMUNOGENICITY | CELLULAR IMMUNITY |
10510510505 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 1 | BASELINE | 2017-05-27 | 3 | RSV1230 | IS | RSV1230-011 | 3 | 13668 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | HUMAN ADENOVIRUS TYPE 26 VECTOR | VECTOR-INDUCED IMMUNOGENICITY | CELLULAR IMMUNITY | 60.8 | SFC/10^6 PBMC | 60.8 | 60.8 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 2 | VISIT 1 | 2017-08-27 | | 4 | RSV1230 | IS | RSV1230-011 | 4 | 13668 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | THERAPEUTIC PEPTIDE | ANTIDRUG IMMUNOGENICITY or ANTIDRUG T CELL-MEDIATED IMMUNOGENICITY | CELLULAR IMMUNITY | 260.5 | SFC/10^6 PBMC | 260.5 | 260.5 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 2 | VISIT 1 | 2017-08-27 |
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