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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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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.
This example shows a Sars-CoV-2 vaccine study where the mechanism of delivery for the study vaccine antigenic component is based off of, and enabled by the viral vector technology. In this specific use-case, the transgene encoding the full-length, membrane-bound severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein is incorporated into a recombinant, replication-incompetent Human Adenovirus Type 26 (Ad26) Vector. The Sars-CoV-2 spike protein expressed by the transgene is the antigenic component of this vaccine. The "Ad26.COV2.S" study vaccine is then administered to patients. Neutralizing anti-vector antibodies (i.e. anti-Ad26 vector antibody) are closely monitored at baseline and post-study vaccine exposure visits. This is because the occurrence of the anti-vector antibodies could significantly hinder the Ad26 vector's ability to deliver the Sars-CoV-2 spike protein transgene to target cells, and consequently, either inhibits the planned vaccine therapy, or diminishes the efficacy of the study vaccine after administration.
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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 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 baseline 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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Dataset2 |
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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 | 1366813998 | 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 | 1366813998 | 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 | RSV1230ABC0910 | IS | RSV1230ABC0910-011 | 3 | 1366813998 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | HUMAN ADENOVIRUS TYPE 26 VECTOR | VECTOR-INDUCED IMMUNOGENICITY | CELLULAR IMMUNITY | 60157.8 | SFC/10^6 PBMC | 60157.860 | 157.8 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 2 | VISIT 1 | 2017-08-27 | 4 | RSV1230ABC0910 | IS | RSV1230ABC0910-011 | 4 | 1366813998 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | THERAPEUTIC PEPTIDE | ANTIDRUG IMMUNOGENICITYor ANTIDRUG T CELL-MEDIATED IMMUNOGENICITY | CELLULAR IMMUNITY | 260295.5 | SFC/10^6 PBMC | 260295.5260 | 295.5 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 2 | VISIT 1 | 2017-08-27 |
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