A Phase 2, Single-Arm, Open-Label Clinical Trial on Adjuvant Peptide-Based Vaccination in Dogs with Aggressive Hemangiosarcoma Undergoing Surgery and Chemotherapy
To test the antitumor effect and safety of peptide-based anticancer vaccination in dogs with hemangiosarcoma undergoing the standard of care (SOC; surgery and doxorubicin), canine hemangiosarcoma cells were infected with Salmonella typhi Ty21a to release immunogenic endoplasmic reticulum stress-rela...
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Veröffentlicht in: | Cancers 2023-08, Vol.15 (17), p.4209 |
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creator | Marconato, Laura Tiraboschi, Luca Aralla, Marina Sabattini, Silvia Melacarne, Alessia Agnoli, Chiara Balboni, Andrea Salvi, Marta Foglia, Armando Punzi, Sofia Romagnoli, Noemi Rescigno, Maria |
description | To test the antitumor effect and safety of peptide-based anticancer vaccination in dogs with hemangiosarcoma undergoing the standard of care (SOC; surgery and doxorubicin), canine hemangiosarcoma cells were infected with Salmonella typhi Ty21a to release immunogenic endoplasmic reticulum stress-related peptides into the extracellular milieu via CX43 hemichannels opening. The infected tumor cell secretome constituted the vaccine. Following the SOC, dogs with biologically aggressive hemangiosarcoma were vaccinated a total of five times, once every 3 weeks, and were followed up with serial imaging. A retrospective population of dogs undergoing the SOC alone served as controls. The primary endpoints were the time to progression (TTP) and overall survival (OS), and the secondary endpoints were toxicity and immune responses. A total of 28 dogs were vaccinated along with the SOC, and 32 received only the SOC. A tumor-specific humoral response along with a vaccine-specific T-cell response was observed. Toxicity did not occur. The TTP and OS were significantly longer in vaccinated versus unvaccinated dogs (TTP: 195 vs. 160 days, respectively; p = 0.001; OS: 276 vs. 175 days, respectively; p = 0.002). One-year survival rates were 35.7% and 6.3% for vaccinated and unvaccinated dogs, respectively. In dogs with hemangiosarcoma undergoing the SOC, the addition of a peptide-based vaccine increased the TTP and OS, while maintaining a safe profile. Moreover, vaccinated dogs developed a tumor-specific response, supporting the feasibility of future phase three studies. |
doi_str_mv | 10.3390/cancers15174209 |
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The infected tumor cell secretome constituted the vaccine. Following the SOC, dogs with biologically aggressive hemangiosarcoma were vaccinated a total of five times, once every 3 weeks, and were followed up with serial imaging. A retrospective population of dogs undergoing the SOC alone served as controls. The primary endpoints were the time to progression (TTP) and overall survival (OS), and the secondary endpoints were toxicity and immune responses. A total of 28 dogs were vaccinated along with the SOC, and 32 received only the SOC. A tumor-specific humoral response along with a vaccine-specific T-cell response was observed. Toxicity did not occur. The TTP and OS were significantly longer in vaccinated versus unvaccinated dogs (TTP: 195 vs. 160 days, respectively; p = 0.001; OS: 276 vs. 175 days, respectively; p = 0.002). One-year survival rates were 35.7% and 6.3% for vaccinated and unvaccinated dogs, respectively. In dogs with hemangiosarcoma undergoing the SOC, the addition of a peptide-based vaccine increased the TTP and OS, while maintaining a safe profile. Moreover, vaccinated dogs developed a tumor-specific response, supporting the feasibility of future phase three studies.</description><identifier>ISSN: 2072-6694</identifier><identifier>EISSN: 2072-6694</identifier><identifier>DOI: 10.3390/cancers15174209</identifier><identifier>PMID: 37686485</identifier><language>eng</language><publisher>Basel: MDPI AG</publisher><subject>Angiosarcoma ; Antibodies ; Antitumor activity ; Bacteria ; Blood ; Bone cancer ; Cancer ; Cancer therapies ; Cancer vaccines ; Cells ; Chemotherapy ; Clinical trials ; Comparative analysis ; Connexin 43 ; Dogs ; Doxorubicin ; Endoplasmic reticulum ; Health aspects ; Immune response ; Immune response (humoral) ; Immunogenicity ; Immunotherapy ; Infections ; Lymphocytes T ; Medical prognosis ; Metastasis ; Peptides ; Salmonella ; Secretome ; Surgery ; Toxicity ; Tumors ; Vaccination ; Vaccines</subject><ispartof>Cancers, 2023-08, Vol.15 (17), p.4209</ispartof><rights>COPYRIGHT 2023 MDPI AG</rights><rights>2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2023 by the authors. 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c420t-e95d59824bc89b3e2dc064350e98cfc6b69d172655e121cbfaaa8a2208d242cc3</cites><orcidid>0000-0002-0273-5583 ; 0000-0002-8817-3728 ; 0000-0001-7005-2736 ; 0000-0002-8049-6645 ; 0000-0002-6464-509X ; 0000-0002-7843-615X ; 0009-0000-0162-9722</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10486958/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10486958/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27923,27924,53790,53792</link.rule.ids></links><search><creatorcontrib>Marconato, Laura</creatorcontrib><creatorcontrib>Tiraboschi, Luca</creatorcontrib><creatorcontrib>Aralla, Marina</creatorcontrib><creatorcontrib>Sabattini, Silvia</creatorcontrib><creatorcontrib>Melacarne, Alessia</creatorcontrib><creatorcontrib>Agnoli, Chiara</creatorcontrib><creatorcontrib>Balboni, Andrea</creatorcontrib><creatorcontrib>Salvi, Marta</creatorcontrib><creatorcontrib>Foglia, Armando</creatorcontrib><creatorcontrib>Punzi, Sofia</creatorcontrib><creatorcontrib>Romagnoli, Noemi</creatorcontrib><creatorcontrib>Rescigno, Maria</creatorcontrib><title>A Phase 2, Single-Arm, Open-Label Clinical Trial on Adjuvant Peptide-Based Vaccination in Dogs with Aggressive Hemangiosarcoma Undergoing Surgery and Chemotherapy</title><title>Cancers</title><description>To test the antitumor effect and safety of peptide-based anticancer vaccination in dogs with hemangiosarcoma undergoing the standard of care (SOC; surgery and doxorubicin), canine hemangiosarcoma cells were infected with Salmonella typhi Ty21a to release immunogenic endoplasmic reticulum stress-related peptides into the extracellular milieu via CX43 hemichannels opening. The infected tumor cell secretome constituted the vaccine. Following the SOC, dogs with biologically aggressive hemangiosarcoma were vaccinated a total of five times, once every 3 weeks, and were followed up with serial imaging. A retrospective population of dogs undergoing the SOC alone served as controls. The primary endpoints were the time to progression (TTP) and overall survival (OS), and the secondary endpoints were toxicity and immune responses. A total of 28 dogs were vaccinated along with the SOC, and 32 received only the SOC. A tumor-specific humoral response along with a vaccine-specific T-cell response was observed. Toxicity did not occur. The TTP and OS were significantly longer in vaccinated versus unvaccinated dogs (TTP: 195 vs. 160 days, respectively; p = 0.001; OS: 276 vs. 175 days, respectively; p = 0.002). One-year survival rates were 35.7% and 6.3% for vaccinated and unvaccinated dogs, respectively. In dogs with hemangiosarcoma undergoing the SOC, the addition of a peptide-based vaccine increased the TTP and OS, while maintaining a safe profile. Moreover, vaccinated dogs developed a tumor-specific response, supporting the feasibility of future phase three studies.</description><subject>Angiosarcoma</subject><subject>Antibodies</subject><subject>Antitumor activity</subject><subject>Bacteria</subject><subject>Blood</subject><subject>Bone cancer</subject><subject>Cancer</subject><subject>Cancer therapies</subject><subject>Cancer vaccines</subject><subject>Cells</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Comparative analysis</subject><subject>Connexin 43</subject><subject>Dogs</subject><subject>Doxorubicin</subject><subject>Endoplasmic reticulum</subject><subject>Health aspects</subject><subject>Immune response</subject><subject>Immune response (humoral)</subject><subject>Immunogenicity</subject><subject>Immunotherapy</subject><subject>Infections</subject><subject>Lymphocytes T</subject><subject>Medical prognosis</subject><subject>Metastasis</subject><subject>Peptides</subject><subject>Salmonella</subject><subject>Secretome</subject><subject>Surgery</subject><subject>Toxicity</subject><subject>Tumors</subject><subject>Vaccination</subject><subject>Vaccines</subject><issn>2072-6694</issn><issn>2072-6694</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNptkk1r3DAQhk1paUKac6-CXnqIE31YsnUq7vYjhYUEkvQqZGns1WJLW8nekr_TX1otCSUJlUAjZp55hxemKN4TfM6YxBdGewMxEU7qimL5qjimuKalELJ6_eR_VJymtMX5MEZqUb8tjlgtGlE1_Lj406LrjU6A6Bm6cX4YoWzjdIauduDLte5gRKvReWf0iG6jy2_wqLXbZa_9jK5hNzsL5eesYNFPbYzzenYZcR59CUNCv928Qe0wREjJ7QFdwqT94ELS0YRJoztvIQ4hT0Y3Sxwg3iPtLVptYArzBqLe3b8r3vR6THD6GE-Ku29fb1eX5frq-49Vuy5Ndj-XILnlsqFVZxrZMaDWYFExjkE2pjeiE9KSmgrOgVBiul5r3WhKcWNpRY1hJ8WnB93d0k1gDfg56lHtopt0vFdBO_W84t1GDWGvCK4aIXmTFT4-KsTwa4E0q8klA-OoPYQlKdoIRiWTNc_ohxfoNizRZ38HipKqxvwJNegRlPN9yIPNQVS1taioqLggmTr_D5WvhcmZ4KF3Of-s4eKhwcSQUoT-n0mC1WG11IvVYn8BMxPBlQ</recordid><startdate>20230822</startdate><enddate>20230822</enddate><creator>Marconato, Laura</creator><creator>Tiraboschi, Luca</creator><creator>Aralla, Marina</creator><creator>Sabattini, Silvia</creator><creator>Melacarne, Alessia</creator><creator>Agnoli, Chiara</creator><creator>Balboni, Andrea</creator><creator>Salvi, Marta</creator><creator>Foglia, Armando</creator><creator>Punzi, Sofia</creator><creator>Romagnoli, Noemi</creator><creator>Rescigno, Maria</creator><general>MDPI AG</general><general>MDPI</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7TO</scope><scope>7XB</scope><scope>8FE</scope><scope>8FH</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>LK8</scope><scope>M2O</scope><scope>M7P</scope><scope>MBDVC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-0273-5583</orcidid><orcidid>https://orcid.org/0000-0002-8817-3728</orcidid><orcidid>https://orcid.org/0000-0001-7005-2736</orcidid><orcidid>https://orcid.org/0000-0002-8049-6645</orcidid><orcidid>https://orcid.org/0000-0002-6464-509X</orcidid><orcidid>https://orcid.org/0000-0002-7843-615X</orcidid><orcidid>https://orcid.org/0009-0000-0162-9722</orcidid></search><sort><creationdate>20230822</creationdate><title>A Phase 2, Single-Arm, Open-Label Clinical Trial on Adjuvant Peptide-Based Vaccination in Dogs with Aggressive Hemangiosarcoma Undergoing Surgery and Chemotherapy</title><author>Marconato, Laura ; Tiraboschi, Luca ; Aralla, Marina ; Sabattini, Silvia ; Melacarne, Alessia ; Agnoli, Chiara ; Balboni, Andrea ; Salvi, Marta ; Foglia, Armando ; Punzi, Sofia ; Romagnoli, Noemi ; Rescigno, Maria</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c420t-e95d59824bc89b3e2dc064350e98cfc6b69d172655e121cbfaaa8a2208d242cc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Angiosarcoma</topic><topic>Antibodies</topic><topic>Antitumor activity</topic><topic>Bacteria</topic><topic>Blood</topic><topic>Bone cancer</topic><topic>Cancer</topic><topic>Cancer therapies</topic><topic>Cancer vaccines</topic><topic>Cells</topic><topic>Chemotherapy</topic><topic>Clinical trials</topic><topic>Comparative analysis</topic><topic>Connexin 43</topic><topic>Dogs</topic><topic>Doxorubicin</topic><topic>Endoplasmic reticulum</topic><topic>Health aspects</topic><topic>Immune response</topic><topic>Immune response (humoral)</topic><topic>Immunogenicity</topic><topic>Immunotherapy</topic><topic>Infections</topic><topic>Lymphocytes T</topic><topic>Medical prognosis</topic><topic>Metastasis</topic><topic>Peptides</topic><topic>Salmonella</topic><topic>Secretome</topic><topic>Surgery</topic><topic>Toxicity</topic><topic>Tumors</topic><topic>Vaccination</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Marconato, Laura</creatorcontrib><creatorcontrib>Tiraboschi, Luca</creatorcontrib><creatorcontrib>Aralla, Marina</creatorcontrib><creatorcontrib>Sabattini, Silvia</creatorcontrib><creatorcontrib>Melacarne, Alessia</creatorcontrib><creatorcontrib>Agnoli, Chiara</creatorcontrib><creatorcontrib>Balboni, Andrea</creatorcontrib><creatorcontrib>Salvi, Marta</creatorcontrib><creatorcontrib>Foglia, Armando</creatorcontrib><creatorcontrib>Punzi, Sofia</creatorcontrib><creatorcontrib>Romagnoli, Noemi</creatorcontrib><creatorcontrib>Rescigno, Maria</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Research Library</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancers</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Marconato, Laura</au><au>Tiraboschi, Luca</au><au>Aralla, Marina</au><au>Sabattini, Silvia</au><au>Melacarne, Alessia</au><au>Agnoli, Chiara</au><au>Balboni, Andrea</au><au>Salvi, Marta</au><au>Foglia, Armando</au><au>Punzi, Sofia</au><au>Romagnoli, Noemi</au><au>Rescigno, Maria</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Phase 2, Single-Arm, Open-Label Clinical Trial on Adjuvant Peptide-Based Vaccination in Dogs with Aggressive Hemangiosarcoma Undergoing Surgery and Chemotherapy</atitle><jtitle>Cancers</jtitle><date>2023-08-22</date><risdate>2023</risdate><volume>15</volume><issue>17</issue><spage>4209</spage><pages>4209-</pages><issn>2072-6694</issn><eissn>2072-6694</eissn><abstract>To test the antitumor effect and safety of peptide-based anticancer vaccination in dogs with hemangiosarcoma undergoing the standard of care (SOC; surgery and doxorubicin), canine hemangiosarcoma cells were infected with Salmonella typhi Ty21a to release immunogenic endoplasmic reticulum stress-related peptides into the extracellular milieu via CX43 hemichannels opening. The infected tumor cell secretome constituted the vaccine. Following the SOC, dogs with biologically aggressive hemangiosarcoma were vaccinated a total of five times, once every 3 weeks, and were followed up with serial imaging. A retrospective population of dogs undergoing the SOC alone served as controls. The primary endpoints were the time to progression (TTP) and overall survival (OS), and the secondary endpoints were toxicity and immune responses. A total of 28 dogs were vaccinated along with the SOC, and 32 received only the SOC. A tumor-specific humoral response along with a vaccine-specific T-cell response was observed. Toxicity did not occur. The TTP and OS were significantly longer in vaccinated versus unvaccinated dogs (TTP: 195 vs. 160 days, respectively; p = 0.001; OS: 276 vs. 175 days, respectively; p = 0.002). One-year survival rates were 35.7% and 6.3% for vaccinated and unvaccinated dogs, respectively. In dogs with hemangiosarcoma undergoing the SOC, the addition of a peptide-based vaccine increased the TTP and OS, while maintaining a safe profile. Moreover, vaccinated dogs developed a tumor-specific response, supporting the feasibility of future phase three studies.</abstract><cop>Basel</cop><pub>MDPI AG</pub><pmid>37686485</pmid><doi>10.3390/cancers15174209</doi><orcidid>https://orcid.org/0000-0002-0273-5583</orcidid><orcidid>https://orcid.org/0000-0002-8817-3728</orcidid><orcidid>https://orcid.org/0000-0001-7005-2736</orcidid><orcidid>https://orcid.org/0000-0002-8049-6645</orcidid><orcidid>https://orcid.org/0000-0002-6464-509X</orcidid><orcidid>https://orcid.org/0000-0002-7843-615X</orcidid><orcidid>https://orcid.org/0009-0000-0162-9722</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Angiosarcoma Antibodies Antitumor activity Bacteria Blood Bone cancer Cancer Cancer therapies Cancer vaccines Cells Chemotherapy Clinical trials Comparative analysis Connexin 43 Dogs Doxorubicin Endoplasmic reticulum Health aspects Immune response Immune response (humoral) Immunogenicity Immunotherapy Infections Lymphocytes T Medical prognosis Metastasis Peptides Salmonella Secretome Surgery Toxicity Tumors Vaccination Vaccines |
title | A Phase 2, Single-Arm, Open-Label Clinical Trial on Adjuvant Peptide-Based Vaccination in Dogs with Aggressive Hemangiosarcoma Undergoing Surgery and Chemotherapy |
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