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Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation
Abstract ADVAX is a DNA-based candidate HIV vaccine that was safe but weakly immunogenic when delivered intramuscularly (IM) in humans. Studies were performed in animal models to determine whether an alternative delivery method, in vivo electroporation (EP), could improve the immunogenicity of ADVAX...
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| Published in: | Vaccine 2011-01, Vol.29 (4), p.795-803 |
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| container_end_page | 803 |
| container_issue | 4 |
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| container_title | Vaccine |
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| creator | Dolter, Karen E Evans, Claire F Ellefsen, Barry Song, Juwan Boente-Carrera, Mar Vittorino, Roselle Rosenberg, Talia J Hannaman, Drew Vasan, Sandhya |
| description | Abstract ADVAX is a DNA-based candidate HIV vaccine that was safe but weakly immunogenic when delivered intramuscularly (IM) in humans. Studies were performed in animal models to determine whether an alternative delivery method, in vivo electroporation (EP), could improve the immunogenicity of ADVAX while maintaining an acceptable safety profile. Immunization of mice with ADVAX with or without EP at weeks 0, 3, and 6, revealed significantly higher gamma interferon ELISpot responses to all antigens in the EP groups. Antigen-specific CD4+ and CD8+ T cell responses, as quantified by intracellular cytokine staining, both improved significantly with EP. Evaluation of repeat-dose toxicity of ADVAX-EP in rabbits did not reveal any safety concerns. Biodistribution studies of ADVAX delivered IM and with EP in rats indicated that the vaccine was localized predominantly to the administration site in both groups. PCR-based quantitation of residual plasmid at Day 60 indicated that the potential for integration events into the host genome was low for both IM and EP delivery. Taken together, these data supported the clinical development of ADVAX delivered with EP in human volunteers. |
| doi_str_mv | 10.1016/j.vaccine.2010.11.011 |
| format | article |
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Studies were performed in animal models to determine whether an alternative delivery method, in vivo electroporation (EP), could improve the immunogenicity of ADVAX while maintaining an acceptable safety profile. Immunization of mice with ADVAX with or without EP at weeks 0, 3, and 6, revealed significantly higher gamma interferon ELISpot responses to all antigens in the EP groups. Antigen-specific CD4+ and CD8+ T cell responses, as quantified by intracellular cytokine staining, both improved significantly with EP. Evaluation of repeat-dose toxicity of ADVAX-EP in rabbits did not reveal any safety concerns. Biodistribution studies of ADVAX delivered IM and with EP in rats indicated that the vaccine was localized predominantly to the administration site in both groups. PCR-based quantitation of residual plasmid at Day 60 indicated that the potential for integration events into the host genome was low for both IM and EP delivery. Taken together, these data supported the clinical development of ADVAX delivered with EP in human volunteers.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2010.11.011</identifier><identifier>PMID: 21094270</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Acquired immune deficiency syndrome ; AIDS ; AIDS Vaccines - administration & dosage ; AIDS Vaccines - adverse effects ; AIDS Vaccines - immunology ; AIDS Vaccines - pharmacokinetics ; Allergy and Immunology ; Animals ; Applied microbiology ; Biological and medical sciences ; CD4-Positive T-Lymphocytes - immunology ; CD8-Positive T-Lymphocytes - immunology ; DNA vaccine ; Electroporation ; Electroporation - methods ; Female ; Fundamental and applied biological sciences. Psychology ; HIV ; HIV-1 - genetics ; HIV-1 - immunology ; Human immunodeficiency virus ; Human immunodeficiency virus 1 ; Immunization ; Immunization, Secondary - methods ; Integration ; Interferon-gamma - secretion ; Male ; Mice ; Mice, Inbred BALB C ; Microbiology ; Miscellaneous ; Plasmids ; Rabbits ; Rats ; Rats, Wistar ; Vaccination - methods ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Vaccines, DNA - administration & dosage ; Vaccines, DNA - adverse effects ; Vaccines, DNA - immunology ; Vaccines, DNA - pharmacokinetics ; Virology</subject><ispartof>Vaccine, 2011-01, Vol.29 (4), p.795-803</ispartof><rights>Elsevier Ltd</rights><rights>2010 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2010 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jan 17, 2011</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c608t-5aa716acdb0b2a9f26d43a30e279eacce54880aa379097f95f65560edaf0a2413</citedby><cites>FETCH-LOGICAL-c608t-5aa716acdb0b2a9f26d43a30e279eacce54880aa379097f95f65560edaf0a2413</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23740371$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21094270$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dolter, Karen E</creatorcontrib><creatorcontrib>Evans, Claire F</creatorcontrib><creatorcontrib>Ellefsen, Barry</creatorcontrib><creatorcontrib>Song, Juwan</creatorcontrib><creatorcontrib>Boente-Carrera, Mar</creatorcontrib><creatorcontrib>Vittorino, Roselle</creatorcontrib><creatorcontrib>Rosenberg, Talia J</creatorcontrib><creatorcontrib>Hannaman, Drew</creatorcontrib><creatorcontrib>Vasan, Sandhya</creatorcontrib><title>Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Abstract ADVAX is a DNA-based candidate HIV vaccine that was safe but weakly immunogenic when delivered intramuscularly (IM) in humans. Studies were performed in animal models to determine whether an alternative delivery method, in vivo electroporation (EP), could improve the immunogenicity of ADVAX while maintaining an acceptable safety profile. Immunization of mice with ADVAX with or without EP at weeks 0, 3, and 6, revealed significantly higher gamma interferon ELISpot responses to all antigens in the EP groups. Antigen-specific CD4+ and CD8+ T cell responses, as quantified by intracellular cytokine staining, both improved significantly with EP. Evaluation of repeat-dose toxicity of ADVAX-EP in rabbits did not reveal any safety concerns. Biodistribution studies of ADVAX delivered IM and with EP in rats indicated that the vaccine was localized predominantly to the administration site in both groups. PCR-based quantitation of residual plasmid at Day 60 indicated that the potential for integration events into the host genome was low for both IM and EP delivery. Taken together, these data supported the clinical development of ADVAX delivered with EP in human volunteers.</description><subject>Acquired immune deficiency syndrome</subject><subject>AIDS</subject><subject>AIDS Vaccines - administration & dosage</subject><subject>AIDS Vaccines - adverse effects</subject><subject>AIDS Vaccines - immunology</subject><subject>AIDS Vaccines - pharmacokinetics</subject><subject>Allergy and Immunology</subject><subject>Animals</subject><subject>Applied microbiology</subject><subject>Biological and medical sciences</subject><subject>CD4-Positive T-Lymphocytes - immunology</subject><subject>CD8-Positive T-Lymphocytes - immunology</subject><subject>DNA vaccine</subject><subject>Electroporation</subject><subject>Electroporation - methods</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HIV</subject><subject>HIV-1 - genetics</subject><subject>HIV-1 - immunology</subject><subject>Human immunodeficiency virus</subject><subject>Human immunodeficiency virus 1</subject><subject>Immunization</subject><subject>Immunization, Secondary - methods</subject><subject>Integration</subject><subject>Interferon-gamma - secretion</subject><subject>Male</subject><subject>Mice</subject><subject>Mice, Inbred BALB C</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Plasmids</subject><subject>Rabbits</subject><subject>Rats</subject><subject>Rats, Wistar</subject><subject>Vaccination - methods</subject><subject>Vaccines</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</subject><subject>Vaccines, DNA - administration & dosage</subject><subject>Vaccines, DNA - adverse effects</subject><subject>Vaccines, DNA - immunology</subject><subject>Vaccines, DNA - pharmacokinetics</subject><subject>Virology</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><recordid>eNqFkk1v00AQhi0EomnhJ4BWQqgc4jCz_r6AohZopAoOQNXbarwewwbHG3btSPkP_GjWSqBSD3AaafTMOx_vRNEzhAUC5q_Xix1pbXpeSJhyuADEB9EMyyKJZYblw2gGMk_jFOH2JDr1fg0AWYLV4-hEIlSpLGAW_VptNmNvv3FvtBn2c-Gp5SnWxjbGD87U42BsL6hvxJadDznuNQvbiuXlzfJ2Lkhsnd1-33ekB6PF5celOI4mWuvE1eomxrlouDM7dtyIei9ML3ZmZwV3rIdQbB1NTZ5Ej1rqPD89xrPo6_t3Xy6u4utPH1YXy-tY51AOcUZUYE66qaGWVLUyb9KEEmBZVBw6c5aWJRAlRQVV0VZZm2dZDtxQCyRTTM6i84NuGPznyH5QG-M1dx31bEevylwWJaYyCeSrf5KYARShWVIE9MU9dG1H14c9FKZViVhClQcqO1DaWe8dt2rrzIbcXiGoyVi1VsfrqclYhaiCsaHu-VF9rDfc_K3642QAXh4B8pq61lGvjb_jkiINU05Cbw8chwPvDDvltZkcbYwLZqjGmv-O8uaegu5MeB_qfvCe_d3WyksF6vP0hdMTIgRNLMrkN8cx2Ek</recordid><startdate>20110117</startdate><enddate>20110117</enddate><creator>Dolter, Karen E</creator><creator>Evans, Claire F</creator><creator>Ellefsen, Barry</creator><creator>Song, Juwan</creator><creator>Boente-Carrera, Mar</creator><creator>Vittorino, Roselle</creator><creator>Rosenberg, Talia J</creator><creator>Hannaman, Drew</creator><creator>Vasan, Sandhya</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7T2</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</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>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7TM</scope></search><sort><creationdate>20110117</creationdate><title>Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation</title><author>Dolter, Karen E ; Evans, Claire F ; Ellefsen, Barry ; Song, Juwan ; Boente-Carrera, Mar ; Vittorino, Roselle ; Rosenberg, Talia J ; Hannaman, Drew ; Vasan, Sandhya</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c608t-5aa716acdb0b2a9f26d43a30e279eacce54880aa379097f95f65560edaf0a2413</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>AIDS</topic><topic>AIDS Vaccines - administration & dosage</topic><topic>AIDS Vaccines - adverse effects</topic><topic>AIDS Vaccines - immunology</topic><topic>AIDS Vaccines - pharmacokinetics</topic><topic>Allergy and Immunology</topic><topic>Animals</topic><topic>Applied microbiology</topic><topic>Biological and medical sciences</topic><topic>CD4-Positive T-Lymphocytes - immunology</topic><topic>CD8-Positive T-Lymphocytes - immunology</topic><topic>DNA vaccine</topic><topic>Electroporation</topic><topic>Electroporation - methods</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. 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Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dolter, Karen E</au><au>Evans, Claire F</au><au>Ellefsen, Barry</au><au>Song, Juwan</au><au>Boente-Carrera, Mar</au><au>Vittorino, Roselle</au><au>Rosenberg, Talia J</au><au>Hannaman, Drew</au><au>Vasan, Sandhya</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2011-01-17</date><risdate>2011</risdate><volume>29</volume><issue>4</issue><spage>795</spage><epage>803</epage><pages>795-803</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><coden>VACCDE</coden><notes>ObjectType-Article-2</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-1</notes><notes>content type line 23</notes><abstract>Abstract ADVAX is a DNA-based candidate HIV vaccine that was safe but weakly immunogenic when delivered intramuscularly (IM) in humans. Studies were performed in animal models to determine whether an alternative delivery method, in vivo electroporation (EP), could improve the immunogenicity of ADVAX while maintaining an acceptable safety profile. Immunization of mice with ADVAX with or without EP at weeks 0, 3, and 6, revealed significantly higher gamma interferon ELISpot responses to all antigens in the EP groups. Antigen-specific CD4+ and CD8+ T cell responses, as quantified by intracellular cytokine staining, both improved significantly with EP. Evaluation of repeat-dose toxicity of ADVAX-EP in rabbits did not reveal any safety concerns. Biodistribution studies of ADVAX delivered IM and with EP in rats indicated that the vaccine was localized predominantly to the administration site in both groups. PCR-based quantitation of residual plasmid at Day 60 indicated that the potential for integration events into the host genome was low for both IM and EP delivery. Taken together, these data supported the clinical development of ADVAX delivered with EP in human volunteers.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>21094270</pmid><doi>10.1016/j.vaccine.2010.11.011</doi><tpages>9</tpages></addata></record> |
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| ispartof | Vaccine, 2011-01, Vol.29 (4), p.795-803 |
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| language | eng |
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| source | ScienceDirect Freedom Collection 2022-2024 |
| subjects | Acquired immune deficiency syndrome AIDS AIDS Vaccines - administration & dosage AIDS Vaccines - adverse effects AIDS Vaccines - immunology AIDS Vaccines - pharmacokinetics Allergy and Immunology Animals Applied microbiology Biological and medical sciences CD4-Positive T-Lymphocytes - immunology CD8-Positive T-Lymphocytes - immunology DNA vaccine Electroporation Electroporation - methods Female Fundamental and applied biological sciences. Psychology HIV HIV-1 - genetics HIV-1 - immunology Human immunodeficiency virus Human immunodeficiency virus 1 Immunization Immunization, Secondary - methods Integration Interferon-gamma - secretion Male Mice Mice, Inbred BALB C Microbiology Miscellaneous Plasmids Rabbits Rats Rats, Wistar Vaccination - methods Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, DNA - administration & dosage Vaccines, DNA - adverse effects Vaccines, DNA - immunology Vaccines, DNA - pharmacokinetics Virology |
| title | Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation |
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