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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 response 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 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 visit 1 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 | RSV1230RSV12301366813998 | 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 | RSV1230RSV12301366813998 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | THERAPEUTIC PEPTIDE | ANTIDRUG IMMUNOGENICITY | CELLULAR IMMUNITY | 10510510505 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 1 | BASELINE | 2017-05-27 | 3 | RSV1230RSV12301366813998 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | HUMAN ADENOVIRUS TYPE 26 VECTOR | VECTOR-INDUCED IMMUNOGENICITY | CELLULAR IMMUNITY | 606060157.8 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 2 | VISIT 1 | 2017-08-27 | 4 | RSV1230RSV12301366813998 | CYKSCTCL | Cytokine-secreting T Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | THERAPEUTIC PEPTIDE | ANTIDRUG IMMUNOGENICITY | CELLULAR IMMUNITY | 260260260295.5 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELL | ELISPOT | 2 | VISIT 1 | 2017-08-27 |
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