A randomized pilot trial testing the safety and immunologic effects of a MAGE-A3 protein plus AS15 immunostimulant administered into muscle or into dermal/subcutaneous sites
Identifieur interne : 002205 ( Main/Exploration ); précédent : 002204; suivant : 002206A randomized pilot trial testing the safety and immunologic effects of a MAGE-A3 protein plus AS15 immunostimulant administered into muscle or into dermal/subcutaneous sites
Auteurs : Craig L. Slingluff [États-Unis] ; Gina R. Petroni [États-Unis] ; Walter C. Olson [États-Unis] ; Mark E. Smolkin [États-Unis] ; Kimberly A. Chianese-Bullock [États-Unis] ; Ileana S. Mauldin [États-Unis] ; Kelly T. Smith [États-Unis] ; Donna H. Deacon [États-Unis] ; Nikole E. Varhegyi [États-Unis] ; Sean B. Donnelly [États-Unis] ; Caroline M. Reed [États-Unis] ; Kristy Scott [États-Unis] ; Nadejda V. Galeassi [États-Unis] ; William W. Grosh [États-Unis]Source :
- Cancer immunology, immunotherapy : CII [ 0340-7004 ] ; 2015.
Abstract
Methods to induce T cell responses to protein vaccines have not been optimized. The immunostimulant AS15 has been administered with the recombinant MAGE-A3 protein (recMAGE-A3) i.m. but not i.d. or s.c. This study tests hypotheses that the i.d./s.c. route is safe and will increase CD4+ and CD8+ T cell responses to MAGE-A3.
Twenty-five patients with resected stage IIB-IV MAGE-A3+ melanoma were randomized to immunization with recMAGE-A3 combined with AS15 immunostimulant (MAGE-A3 immunotherapeutic) either i.m. (Group A, n=13), or i.d./s.c. (Group B, n=12). Adverse events were recorded. Ab responses to MAGE-A3 were measured by ELISA. T cell responses to overlapping MAGE-A3 peptides were assessed in PBMC and a sentinel immunized node (SIN) after 1 in vitro stimulation with recMAGE-A3, by IFNγ ELISPOT assay and by flow cytometry for multifunctional (TNFα/IFNγ) responses.
Both routes of immunization were well tolerated without treatment-related grade 3 adverse events. All patients had durable Ab responses. For all 25 patients, the T cell response rate by ELISPOT assay was 30% in SIN (7/23) but only 4% (1/25) in PBMC. By flow cytometry, multifunctional CD8+ T cell responses were identified in 1 patient in each group; multifunctional CD4+ T cell response rates for Groups A and B, respectively, were 31% and 64% in SIN, and 31% and 50% in PBMC.
The MAGE-A3 immunotherapeutic was well tolerated after i.d./s.c. administration, with trends to higher CD4+ T cell response rates than with i.m. administration. This study supports further study of AS15 by i.d./s.c. administration.
Url:
DOI: 10.1007/s00262-015-1770-9
PubMed: 26581199
PubMed Central: 5010424
Affiliations:
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Slingluff</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Petroni, Gina R" sort="Petroni, Gina R" uniqKey="Petroni G" first="Gina R." last="Petroni">Gina R. 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Slingluff</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Petroni, Gina R" sort="Petroni, Gina R" uniqKey="Petroni G" first="Gina R." last="Petroni">Gina R. Petroni</name><affiliation wicri:level="1"><nlm:aff id="A2">Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Public Health Sciences, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Olson, Walter C" sort="Olson, Walter C" uniqKey="Olson W" first="Walter C." last="Olson">Walter C. Olson</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Smolkin, Mark E" sort="Smolkin, Mark E" uniqKey="Smolkin M" first="Mark E." last="Smolkin">Mark E. Smolkin</name><affiliation wicri:level="1"><nlm:aff id="A2">Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Public Health Sciences, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Chianese Bullock, Kimberly A" sort="Chianese Bullock, Kimberly A" uniqKey="Chianese Bullock K" first="Kimberly A." last="Chianese-Bullock">Kimberly A. Chianese-Bullock</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Mauldin, Ileana S" sort="Mauldin, Ileana S" uniqKey="Mauldin I" first="Ileana S." last="Mauldin">Ileana S. Mauldin</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Smith, Kelly T" sort="Smith, Kelly T" uniqKey="Smith K" first="Kelly T" last="Smith">Kelly T. Smith</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Deacon, Donna H" sort="Deacon, Donna H" uniqKey="Deacon D" first="Donna H." last="Deacon">Donna H. Deacon</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Varhegyi, Nikole E" sort="Varhegyi, Nikole E" uniqKey="Varhegyi N" first="Nikole E." last="Varhegyi">Nikole E. Varhegyi</name><affiliation wicri:level="1"><nlm:aff id="A2">Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Public Health Sciences, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Donnelly, Sean B" sort="Donnelly, Sean B" uniqKey="Donnelly S" first="Sean B." last="Donnelly">Sean B. Donnelly</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Reed, Caroline M" sort="Reed, Caroline M" uniqKey="Reed C" first="Caroline M." last="Reed">Caroline M. Reed</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Scott, Kristy" sort="Scott, Kristy" uniqKey="Scott K" first="Kristy" last="Scott">Kristy Scott</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Galeassi, Nadejda V" sort="Galeassi, Nadejda V" uniqKey="Galeassi N" first="Nadejda V." last="Galeassi">Nadejda V. Galeassi</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery/Division of Surgical Oncology and the Human Immune Therapy Center, Cancer Center, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author><author><name sortKey="Grosh, William W" sort="Grosh, William W" uniqKey="Grosh W" first="William W." last="Grosh">William W. Grosh</name><affiliation wicri:level="1"><nlm:aff id="A3">Department of Medicine/Division of Hematology-Oncology, University of Virginia, Charlottesville, VA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine/Division of Hematology-Oncology, University of Virginia, Charlottesville, VA</wicri:regionArea><wicri:noRegion>VA</wicri:noRegion></affiliation></author></analytic><series><title level="j">Cancer immunology, immunotherapy : CII</title><idno type="ISSN">0340-7004</idno><idno type="eISSN">1432-0851</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Introduction</title><p id="P1">Methods to induce T cell responses to protein vaccines have not been optimized. The immunostimulant AS15 has been administered with the recombinant MAGE-A3 protein (recMAGE-A3) i.m. but not i.d. or s.c. This study tests hypotheses that the i.d./s.c. route is safe and will increase CD4<sup>+</sup> and CD8<sup>+</sup> T cell responses to MAGE-A3.</p></sec><sec id="S2"><title>Patients and Methods</title><p id="P2">Twenty-five patients with resected stage IIB-IV MAGE-A3<sup>+</sup> melanoma were randomized to immunization with recMAGE-A3 combined with AS15 immunostimulant (MAGE-A3 immunotherapeutic) either i.m. (Group A, n=13), or i.d./s.c. (Group B, n=12). Adverse events were recorded. Ab responses to MAGE-A3 were measured by ELISA. T cell responses to overlapping MAGE-A3 peptides were assessed in PBMC and a sentinel immunized node (SIN) after 1 in vitro stimulation with recMAGE-A3, by IFNγ ELISPOT assay and by flow cytometry for multifunctional (TNFα/IFNγ) responses.</p></sec><sec id="S3"><title>Results</title><p id="P3">Both routes of immunization were well tolerated without treatment-related grade 3 adverse events. All patients had durable Ab responses. For all 25 patients, the T cell response rate by ELISPOT assay was 30% in SIN (7/23) but only 4% (1/25) in PBMC. By flow cytometry, multifunctional CD8<sup>+</sup> T cell responses were identified in 1 patient in each group; multifunctional CD4<sup>+</sup> T cell response rates for Groups A and B, respectively, were 31% and 64% in SIN, and 31% and 50% in PBMC.</p></sec><sec id="S4"><title>Conclusion</title><p id="P4">The MAGE-A3 immunotherapeutic was well tolerated after i.d./s.c. administration, with trends to higher CD4<sup>+</sup> T cell response rates than with i.m. administration. This study supports further study of AS15 by i.d./s.c. administration.</p></sec></div></front></TEI><affiliations><list><country><li>États-Unis</li></country></list><tree><country name="États-Unis"><noRegion><name sortKey="Slingluff, Craig L" sort="Slingluff, Craig L" uniqKey="Slingluff C" first="Craig L." last="Slingluff">Craig L. Slingluff</name></noRegion><name sortKey="Chianese Bullock, Kimberly A" sort="Chianese Bullock, Kimberly A" uniqKey="Chianese Bullock K" first="Kimberly A." last="Chianese-Bullock">Kimberly A. Chianese-Bullock</name><name sortKey="Deacon, Donna H" sort="Deacon, Donna H" uniqKey="Deacon D" first="Donna H." last="Deacon">Donna H. Deacon</name><name sortKey="Donnelly, Sean B" sort="Donnelly, Sean B" uniqKey="Donnelly S" first="Sean B." last="Donnelly">Sean B. Donnelly</name><name sortKey="Galeassi, Nadejda V" sort="Galeassi, Nadejda V" uniqKey="Galeassi N" first="Nadejda V." last="Galeassi">Nadejda V. Galeassi</name><name sortKey="Grosh, William W" sort="Grosh, William W" uniqKey="Grosh W" first="William W." last="Grosh">William W. Grosh</name><name sortKey="Mauldin, Ileana S" sort="Mauldin, Ileana S" uniqKey="Mauldin I" first="Ileana S." last="Mauldin">Ileana S. Mauldin</name><name sortKey="Olson, Walter C" sort="Olson, Walter C" uniqKey="Olson W" first="Walter C." last="Olson">Walter C. Olson</name><name sortKey="Petroni, Gina R" sort="Petroni, Gina R" uniqKey="Petroni G" first="Gina R." last="Petroni">Gina R. Petroni</name><name sortKey="Reed, Caroline M" sort="Reed, Caroline M" uniqKey="Reed C" first="Caroline M." last="Reed">Caroline M. Reed</name><name sortKey="Scott, Kristy" sort="Scott, Kristy" uniqKey="Scott K" first="Kristy" last="Scott">Kristy Scott</name><name sortKey="Smith, Kelly T" sort="Smith, Kelly T" uniqKey="Smith K" first="Kelly T" last="Smith">Kelly T. Smith</name><name sortKey="Smolkin, Mark E" sort="Smolkin, Mark E" uniqKey="Smolkin M" first="Mark E." last="Smolkin">Mark E. Smolkin</name><name sortKey="Varhegyi, Nikole E" sort="Varhegyi, Nikole E" uniqKey="Varhegyi N" first="Nikole E." last="Varhegyi">Nikole E. Varhegyi</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= A randomized pilot trial testing the safety and immunologic effects of a MAGE-A3 protein plus AS15 immunostimulant administered into muscle or into dermal/subcutaneous sites
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