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The example below shows a use-case of undesired cellular immune response responses toward a protein therapeutic delivered through the viral vector technology. In this case, T-cell responses to both the viral vector and the therapeutic peptide are undesired/unwanted.
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Rows 1-2: | Show the measurement of interferon gamma (ISMSCBCE) cytokine-secreting T cells (ISTEST) at baseline in response to stimulation by the viral vector and the therapeutic peptide (translated from the transgene delivered by the vector) in ISCNDAGT, respectively, prior to study treatment. | Rows 3-4: | Show the measurement of interferon gamma (ISMSCBCE) cytokine-secreting T cells (ISTEST) at baseline in response to stimulation by the viral vector and the therapeutic peptide (translated from the transgene delivered by the vector) in ISCNDAGT, 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 | 7.05 | SFC/10^6 PBMC | 7.05 | 7.05 | 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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