Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine
Abstract Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellul...
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Veröffentlicht in: | Vaccine 2007-05, Vol.25 (20), p.4085-4092 |
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creator | Catanzaro, Andrew T Roederer, Mario Koup, Richard A Bailer, Robert T Enama, Mary E Nason, Martha C Martin, Julie E Rucker, Steve Andrews, Charla A Gomez, Phillip L Mascola, John R Nabel, Gary J Graham, Barney S |
description | Abstract Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4+ [13/14 (93%)] and CD8+ [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation. |
doi_str_mv | 10.1016/j.vaccine.2007.02.050 |
format | Article |
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T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4+ [13/14 (93%)] and CD8+ [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2007.02.050</identifier><identifier>PMID: 17391815</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Acquired immune deficiency syndrome ; Adolescent ; Adult ; AIDS ; AIDS Vaccines - administration & dosage ; AIDS Vaccines - adverse effects ; AIDS Vaccines - genetics ; AIDS Vaccines - immunology ; Allergy and Immunology ; Applied microbiology ; Biological and medical sciences ; CD4-Positive T-Lymphocytes - immunology ; CD8-Positive T-Lymphocytes - immunology ; Deoxyribonucleic acid ; DNA ; Envelope ; Female ; Fundamental and applied biological sciences. Psychology ; Gag ; Gene Products, env - immunology ; Gene Products, gag - immunology ; Gene Products, nef - immunology ; HIV ; HIV Antibodies - biosynthesis ; HIV Antibodies - immunology ; HIV Infections - immunology ; HIV Infections - prevention & control ; HIV Infections - virology ; HIV-1 - genetics ; HIV-1 - immunology ; Human immunodeficiency virus ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Immunity, Cellular - immunology ; Infectious diseases ; Laboratories ; Male ; Medical sciences ; Microbiology ; Miscellaneous ; Nef ; nef Gene Products, Human Immunodeficiency Virus ; Plasmids ; Plasmids - genetics ; Plasmids - immunology ; Pol ; Prevention ; Promoter ; T cell response ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Vaccines, Combined - administration & dosage ; Vaccines, Combined - adverse effects ; Vaccines, Combined - genetics ; Vaccines, Combined - immunology ; Vaccines, DNA - administration & dosage ; Vaccines, DNA - adverse effects ; Vaccines, DNA - genetics ; Vaccines, DNA - immunology ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Virology</subject><ispartof>Vaccine, 2007-05, Vol.25 (20), p.4085-4092</ispartof><rights>2007</rights><rights>2007 INIST-CNRS</rights><rights>Copyright Elsevier Limited May 16, 2007</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c507t-6ed498155cbb90eb2035147555a28813fa8f702c6f60a643b1730e23f37074103</citedby><cites>FETCH-LOGICAL-c507t-6ed498155cbb90eb2035147555a28813fa8f702c6f60a643b1730e23f37074103</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0264410X07001909$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18739289$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17391815$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Catanzaro, Andrew T</creatorcontrib><creatorcontrib>Roederer, Mario</creatorcontrib><creatorcontrib>Koup, Richard A</creatorcontrib><creatorcontrib>Bailer, Robert T</creatorcontrib><creatorcontrib>Enama, Mary E</creatorcontrib><creatorcontrib>Nason, Martha C</creatorcontrib><creatorcontrib>Martin, Julie E</creatorcontrib><creatorcontrib>Rucker, Steve</creatorcontrib><creatorcontrib>Andrews, Charla A</creatorcontrib><creatorcontrib>Gomez, Phillip L</creatorcontrib><creatorcontrib>Mascola, John R</creatorcontrib><creatorcontrib>Nabel, Gary J</creatorcontrib><creatorcontrib>Graham, Barney S</creatorcontrib><creatorcontrib>The VRC 007 Study Team</creatorcontrib><creatorcontrib>VRC 007 Study Team</creatorcontrib><title>Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Abstract Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4+ [13/14 (93%)] and CD8+ [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adolescent</subject><subject>Adult</subject><subject>AIDS</subject><subject>AIDS Vaccines - administration & dosage</subject><subject>AIDS Vaccines - adverse effects</subject><subject>AIDS Vaccines - genetics</subject><subject>AIDS Vaccines - immunology</subject><subject>Allergy and Immunology</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>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>Envelope</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Gag</subject><subject>Gene Products, env - immunology</subject><subject>Gene Products, gag - immunology</subject><subject>Gene Products, nef - immunology</subject><subject>HIV</subject><subject>HIV Antibodies - biosynthesis</subject><subject>HIV Antibodies - immunology</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - prevention & control</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - genetics</subject><subject>HIV-1 - immunology</subject><subject>Human immunodeficiency virus</subject><subject>Human immunodeficiency virus 1</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunity, Cellular - immunology</subject><subject>Infectious diseases</subject><subject>Laboratories</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Nef</subject><subject>nef Gene Products, Human Immunodeficiency Virus</subject><subject>Plasmids</subject><subject>Plasmids - genetics</subject><subject>Plasmids - immunology</subject><subject>Pol</subject><subject>Prevention</subject><subject>Promoter</subject><subject>T cell response</subject><subject>Vaccines</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</subject><subject>Vaccines, Combined - administration & dosage</subject><subject>Vaccines, Combined - adverse effects</subject><subject>Vaccines, Combined - genetics</subject><subject>Vaccines, Combined - immunology</subject><subject>Vaccines, DNA - administration & dosage</subject><subject>Vaccines, DNA - adverse effects</subject><subject>Vaccines, DNA - genetics</subject><subject>Vaccines, DNA - immunology</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. 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Psychology</topic><topic>Gag</topic><topic>Gene Products, env - immunology</topic><topic>Gene Products, gag - immunology</topic><topic>Gene Products, nef - immunology</topic><topic>HIV</topic><topic>HIV Antibodies - biosynthesis</topic><topic>HIV Antibodies - immunology</topic><topic>HIV Infections - immunology</topic><topic>HIV Infections - prevention & control</topic><topic>HIV Infections - virology</topic><topic>HIV-1 - genetics</topic><topic>HIV-1 - immunology</topic><topic>Human immunodeficiency virus</topic><topic>Human immunodeficiency virus 1</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunity, Cellular - immunology</topic><topic>Infectious diseases</topic><topic>Laboratories</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Miscellaneous</topic><topic>Nef</topic><topic>nef Gene Products, Human Immunodeficiency Virus</topic><topic>Plasmids</topic><topic>Plasmids - genetics</topic><topic>Plasmids - immunology</topic><topic>Pol</topic><topic>Prevention</topic><topic>Promoter</topic><topic>T cell response</topic><topic>Vaccines</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</topic><topic>Vaccines, Combined - administration & dosage</topic><topic>Vaccines, Combined - adverse effects</topic><topic>Vaccines, Combined - genetics</topic><topic>Vaccines, Combined - immunology</topic><topic>Vaccines, DNA - administration & dosage</topic><topic>Vaccines, DNA - adverse effects</topic><topic>Vaccines, DNA - genetics</topic><topic>Vaccines, DNA - immunology</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. 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T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4+ [13/14 (93%)] and CD8+ [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>17391815</pmid><doi>10.1016/j.vaccine.2007.02.050</doi><tpages>8</tpages></addata></record> |
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subjects | Acquired immune deficiency syndrome Adolescent Adult AIDS AIDS Vaccines - administration & dosage AIDS Vaccines - adverse effects AIDS Vaccines - genetics AIDS Vaccines - immunology Allergy and Immunology Applied microbiology Biological and medical sciences CD4-Positive T-Lymphocytes - immunology CD8-Positive T-Lymphocytes - immunology Deoxyribonucleic acid DNA Envelope Female Fundamental and applied biological sciences. Psychology Gag Gene Products, env - immunology Gene Products, gag - immunology Gene Products, nef - immunology HIV HIV Antibodies - biosynthesis HIV Antibodies - immunology HIV Infections - immunology HIV Infections - prevention & control HIV Infections - virology HIV-1 - genetics HIV-1 - immunology Human immunodeficiency virus Human immunodeficiency virus 1 Human viral diseases Humans Immunity, Cellular - immunology Infectious diseases Laboratories Male Medical sciences Microbiology Miscellaneous Nef nef Gene Products, Human Immunodeficiency Virus Plasmids Plasmids - genetics Plasmids - immunology Pol Prevention Promoter T cell response Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Combined - administration & dosage Vaccines, Combined - adverse effects Vaccines, Combined - genetics Vaccines, Combined - immunology Vaccines, DNA - administration & dosage Vaccines, DNA - adverse effects Vaccines, DNA - genetics Vaccines, DNA - immunology Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Virology |
title | Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine |
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