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From the Rare Disease TAUG 1st IS.xpt | Rare Diseases Therapeutic Area User Guide, section 9.1, In Vivo Gene Therapy (Spinal Muscular Atrophy). | From the Rare Disease TAUG- Example added to the SDTMIG v4.0.
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From Stefan Konermann. 2nd IS.xpt | Email from Stephen on 2023-09-01. 2023-09-07: - Team agrees to add ISTEST = Cytokine-secreting T Cells
- Team agrees to two ISCATs= VECTOR-INDUCED IMMUNOGENICITY and ANTIDRUG IMMUNOGENICITY.
- Action Item: Jordan to add this example to the SDTMIG v4.0.
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Yellowin progress
Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. An immunogenicity response may be wanted/desired or unwanted/undesired.
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The example below shows a use-case of undesired, unwanted cellular immune responses toward a protein therapeutic delivered through the viral vector technology. In this case, cellular T-cell responses to both the viral vector and the therapeutic peptide (which is translated from the transgene delivered by the viral vector), are measured before and after study treatment. The T cell responses to both the vector and the theraptucis peptide are considered as "undesired/unwanted", which are indicated by the ISCAT = VECTOR-INDUCED IMMUNOGENICITY, and ISCAT = ANTIDRUG T CELL-MEDIATED IMMUNOGENICITY.
Additionally, both anti-drug antibodies (ADA) and anti-drug T cell-mediated immunogenicity are considered as "anti-drug immunogenicity".
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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 visit 1 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 | RSV1230ABC0910 | IS | RSV1230ABC0910-011 | 1 | 13998 | 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 | RSV1230ABC0910 | IS | RSV1230ABC0910-011 | 2 | 13998 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | THERAPEUTIC PEPTIDE | ANTIDRUG 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 | RSV1230ABC0910 | IS | RSV1230ABC0910-011 | 3 | 13998 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | HUMAN ADENOVIRUS TYPE 26 VECTOR | VECTOR-INDUCED IMMUNOGENICITY | CELLULAR IMMUNITY | 157.8 | SFC/10^6 PBMC | 157.8 | 157.8 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 2 | VISIT 1 | 2017-08-27 | | 4 | RSV1230ABC0910 | IS | RSV1230ABC0910-011 | 4 | 13998 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | THERAPEUTIC PEPTIDE | ANTIDRUG IMMUNOGENICITY | CELLULAR IMMUNITY | 295.5 | SFC/10^6 PBMC | 295.5 | 295.5 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 2 | VISIT 1 | 2017-08-27 |
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