A Phase 1 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Subtype C Adeno-Associated Virus Vaccine
A novel prophylactic AIDS vaccine candidate, consisting of single-stranded DNA for HIV-1 subtype C gag, protease, and part of reverse transcriptase genes, enclosed within a recombinant adeno-associated virus serotype-2 protein capsid (tgAAC09) induced T cell responses and antibodies in nonhuman prim...
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| Veröffentlicht in: | AIDS research and human retroviruses 2008-06, Vol.24 (6), p.873-880 |
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| creator | MEHENDALE, Sanjay VAN LUNZEN, Jan LEHRMAN, Jennifer SCHMIDT, Claudia PEETERS, Mathieu SCHWARZE-ZANDER, Carolynne KABAMBA, Kabeya GLAUNSINGER, Tobias SAHAY, Seema THAKAR, Madhuri PARANJAPE, Ramesh GILMOUR, Jill CLUMECK, Nathan EXCLER, Jean-Louis FAST, Patricia HEALD, Alison E ROCKSTROH, Jurgen VETS, Eva JOHNSON, Philip R ANKLESARIA, Pervin BARIN, Burc BOAZ, Mark KOCHHAR, Sonali |
| description | A novel prophylactic AIDS vaccine candidate, consisting of single-stranded DNA for HIV-1 subtype C gag, protease, and part of reverse transcriptase genes, enclosed within a recombinant adeno-associated virus serotype-2 protein capsid (tgAAC09) induced T cell responses and antibodies in nonhuman primates. In this randomized, dose escalation phase I trial, HIV-uninfected healthy volunteers (50 in Europe, 30 in India) received a single intramuscular injection of tgAAC09 at 3 x 10(9) DNase resistant particles (DRP) (n = 16), 3 x 10(10) DRP (n = 23), 3 x 10(11) DRP (n = 25), or placebo (n = 16). Twenty-one participants in Europe received a second (boost) dose of 3 x 10(11) DRP tgAAC09 or placebo at least 24 weeks after the first injection. The vaccine was safe and well-tolerated after initial and boost vaccination. Local and systemic reactogenicity was experienced by 13-25% of participants and was not dose related. No vaccine-related serious adverse events were reported. Modest HIV-specific T cell responses were detected in 7/64 vaccinees (40-385 SFC/10(6) PBMC), with 16% (4/25) responders in the highest dose group. All responses were to Gag epitopes. tgAAC09 appears to be safe, well-tolerated, and modestly immunogenic. Further evaluation of higher doses of tgAAC09 and boost injections is ongoing in Africa. |
| doi_str_mv | 10.1089/aid.2007.0292 |
| format | Article |
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In this randomized, dose escalation phase I trial, HIV-uninfected healthy volunteers (50 in Europe, 30 in India) received a single intramuscular injection of tgAAC09 at 3 x 10(9) DNase resistant particles (DRP) (n = 16), 3 x 10(10) DRP (n = 23), 3 x 10(11) DRP (n = 25), or placebo (n = 16). Twenty-one participants in Europe received a second (boost) dose of 3 x 10(11) DRP tgAAC09 or placebo at least 24 weeks after the first injection. The vaccine was safe and well-tolerated after initial and boost vaccination. Local and systemic reactogenicity was experienced by 13-25% of participants and was not dose related. No vaccine-related serious adverse events were reported. Modest HIV-specific T cell responses were detected in 7/64 vaccinees (40-385 SFC/10(6) PBMC), with 16% (4/25) responders in the highest dose group. All responses were to Gag epitopes. tgAAC09 appears to be safe, well-tolerated, and modestly immunogenic. Further evaluation of higher doses of tgAAC09 and boost injections is ongoing in Africa.</description><identifier>ISSN: 0889-2229</identifier><identifier>EISSN: 1931-8405</identifier><identifier>DOI: 10.1089/aid.2007.0292</identifier><identifier>PMID: 18544020</identifier><identifier>CODEN: ARHRE7</identifier><language>eng</language><publisher>Larchmont, NY: Liebert</publisher><subject>Adolescent ; Adult ; AIDS Vaccines - administration & dosage ; AIDS Vaccines - adverse effects ; AIDS/HIV ; Antibody Formation ; Biological and medical sciences ; Capsid - immunology ; Dependovirus - immunology ; DNA, Viral - administration & dosage ; Double-Blind Method ; Female ; Fundamental and applied biological sciences. Psychology ; gag Gene Products, Human Immunodeficiency Virus - immunology ; Health aspects ; HIV infection ; HIV Infections - prevention & control ; HIV-1 - immunology ; Human viral diseases ; Humans ; Immunity, Cellular ; Immunization, Secondary ; Infectious diseases ; Injections, Intramuscular ; Interferon-gamma - blood ; Male ; Medical sciences ; Microbiology ; Middle Aged ; Miscellaneous ; Neutralization Tests ; Physiological aspects ; Prevention ; T-Lymphocytes - immunology ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies ; Vaccines, DNA - administration & dosage ; Vaccines, DNA - adverse effects ; Vaccines, DNA - immunology ; Vaccines, Virosome - administration & dosage ; Vaccines, Virosome - adverse effects ; Viral diseases ; Viral vaccines ; Virology</subject><ispartof>AIDS research and human retroviruses, 2008-06, Vol.24 (6), p.873-880</ispartof><rights>2008 INIST-CNRS</rights><rights>COPYRIGHT 2008 Mary Ann Liebert, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c388t-b0c75203a8913786cd74e1f37f2c06c9d76a78dbe7ea5e6a26f43a126fa9bae33</citedby><cites>FETCH-LOGICAL-c388t-b0c75203a8913786cd74e1f37f2c06c9d76a78dbe7ea5e6a26f43a126fa9bae33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3029,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20525542$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18544020$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>MEHENDALE, Sanjay</creatorcontrib><creatorcontrib>VAN LUNZEN, Jan</creatorcontrib><creatorcontrib>LEHRMAN, Jennifer</creatorcontrib><creatorcontrib>SCHMIDT, Claudia</creatorcontrib><creatorcontrib>PEETERS, Mathieu</creatorcontrib><creatorcontrib>SCHWARZE-ZANDER, Carolynne</creatorcontrib><creatorcontrib>KABAMBA, Kabeya</creatorcontrib><creatorcontrib>GLAUNSINGER, Tobias</creatorcontrib><creatorcontrib>SAHAY, Seema</creatorcontrib><creatorcontrib>THAKAR, Madhuri</creatorcontrib><creatorcontrib>PARANJAPE, Ramesh</creatorcontrib><creatorcontrib>GILMOUR, Jill</creatorcontrib><creatorcontrib>CLUMECK, Nathan</creatorcontrib><creatorcontrib>EXCLER, Jean-Louis</creatorcontrib><creatorcontrib>FAST, Patricia</creatorcontrib><creatorcontrib>HEALD, Alison E</creatorcontrib><creatorcontrib>ROCKSTROH, Jurgen</creatorcontrib><creatorcontrib>VETS, Eva</creatorcontrib><creatorcontrib>JOHNSON, Philip R</creatorcontrib><creatorcontrib>ANKLESARIA, Pervin</creatorcontrib><creatorcontrib>BARIN, Burc</creatorcontrib><creatorcontrib>BOAZ, Mark</creatorcontrib><creatorcontrib>KOCHHAR, Sonali</creatorcontrib><title>A Phase 1 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Subtype C Adeno-Associated Virus Vaccine</title><title>AIDS research and human retroviruses</title><addtitle>AIDS Res Hum Retroviruses</addtitle><description>A novel prophylactic AIDS vaccine candidate, consisting of single-stranded DNA for HIV-1 subtype C gag, protease, and part of reverse transcriptase genes, enclosed within a recombinant adeno-associated virus serotype-2 protein capsid (tgAAC09) induced T cell responses and antibodies in nonhuman primates. In this randomized, dose escalation phase I trial, HIV-uninfected healthy volunteers (50 in Europe, 30 in India) received a single intramuscular injection of tgAAC09 at 3 x 10(9) DNase resistant particles (DRP) (n = 16), 3 x 10(10) DRP (n = 23), 3 x 10(11) DRP (n = 25), or placebo (n = 16). Twenty-one participants in Europe received a second (boost) dose of 3 x 10(11) DRP tgAAC09 or placebo at least 24 weeks after the first injection. The vaccine was safe and well-tolerated after initial and boost vaccination. Local and systemic reactogenicity was experienced by 13-25% of participants and was not dose related. No vaccine-related serious adverse events were reported. Modest HIV-specific T cell responses were detected in 7/64 vaccinees (40-385 SFC/10(6) PBMC), with 16% (4/25) responders in the highest dose group. All responses were to Gag epitopes. tgAAC09 appears to be safe, well-tolerated, and modestly immunogenic. Further evaluation of higher doses of tgAAC09 and boost injections is ongoing in Africa.</description><subject>Adolescent</subject><subject>Adult</subject><subject>AIDS Vaccines - administration & dosage</subject><subject>AIDS Vaccines - adverse effects</subject><subject>AIDS/HIV</subject><subject>Antibody Formation</subject><subject>Biological and medical sciences</subject><subject>Capsid - immunology</subject><subject>Dependovirus - immunology</subject><subject>DNA, Viral - administration & dosage</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>gag Gene Products, Human Immunodeficiency Virus - immunology</subject><subject>Health aspects</subject><subject>HIV infection</subject><subject>HIV Infections - prevention & control</subject><subject>HIV-1 - immunology</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunity, Cellular</subject><subject>Immunization, Secondary</subject><subject>Infectious diseases</subject><subject>Injections, Intramuscular</subject><subject>Interferon-gamma - blood</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Neutralization Tests</subject><subject>Physiological aspects</subject><subject>Prevention</subject><subject>T-Lymphocytes - immunology</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies</subject><subject>Vaccines, DNA - administration & dosage</subject><subject>Vaccines, DNA - adverse effects</subject><subject>Vaccines, DNA - immunology</subject><subject>Vaccines, Virosome - administration & dosage</subject><subject>Vaccines, Virosome - adverse effects</subject><subject>Viral diseases</subject><subject>Viral vaccines</subject><subject>Virology</subject><issn>0889-2229</issn><issn>1931-8405</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkU2LFDEQhoMo7rh69CoB0VuPSforfRyG1R1YUNx1rqE6qexGupOxk16Yi7_dtDMogtShiuKpl5CHkNecrTmT3QdwZi0Ya9dMdOIJWfGu5IWsWP2UrJiUXSGE6C7Iixi_M8Y6Iern5ILLuqqYYCvyc0O_PEBEyultms2RpkCvHmGYISFND0hvwWI6UvCG7sZx9uEevdMur4KlQL-iDmPvPPhEr3d7enc8_M6a-7RMW7ox6EOxiTFolzMN3btpjnQPWjuPL8kzC0PEV-d-Sb59vLrbXhc3nz_ttpubQpdSpqJnuq0FK0F2vGxlo01bIbdla4Vmje5M20ArTY8tQo0NiMZWJfDcoOsBy_KSvD_lHqbwY8aY1OiixmEAj2GOqskfU4mmzuDbE3gPAyrnbUgT6AVWGy5FxZpWyEyt_0PlMjg6HTxal_f_HBSnAz2FGCe06jC5Eaaj4kwtHlX2qBaPavGY-Tfn9879iOYvfRaXgXdnAKKGwU7gtYt_OMFqUdeVKH8BGC6jbg</recordid><startdate>20080601</startdate><enddate>20080601</enddate><creator>MEHENDALE, Sanjay</creator><creator>VAN LUNZEN, Jan</creator><creator>LEHRMAN, Jennifer</creator><creator>SCHMIDT, Claudia</creator><creator>PEETERS, Mathieu</creator><creator>SCHWARZE-ZANDER, Carolynne</creator><creator>KABAMBA, Kabeya</creator><creator>GLAUNSINGER, Tobias</creator><creator>SAHAY, Seema</creator><creator>THAKAR, Madhuri</creator><creator>PARANJAPE, Ramesh</creator><creator>GILMOUR, Jill</creator><creator>CLUMECK, Nathan</creator><creator>EXCLER, Jean-Louis</creator><creator>FAST, Patricia</creator><creator>HEALD, Alison E</creator><creator>ROCKSTROH, Jurgen</creator><creator>VETS, Eva</creator><creator>JOHNSON, Philip R</creator><creator>ANKLESARIA, Pervin</creator><creator>BARIN, Burc</creator><creator>BOAZ, Mark</creator><creator>KOCHHAR, Sonali</creator><general>Liebert</general><general>Mary Ann Liebert, Inc</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>7X8</scope></search><sort><creationdate>20080601</creationdate><title>A Phase 1 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Subtype C Adeno-Associated Virus Vaccine</title><author>MEHENDALE, Sanjay ; VAN LUNZEN, Jan ; LEHRMAN, Jennifer ; SCHMIDT, Claudia ; PEETERS, Mathieu ; SCHWARZE-ZANDER, Carolynne ; KABAMBA, Kabeya ; GLAUNSINGER, Tobias ; SAHAY, Seema ; THAKAR, Madhuri ; PARANJAPE, Ramesh ; GILMOUR, Jill ; CLUMECK, Nathan ; EXCLER, Jean-Louis ; FAST, Patricia ; HEALD, Alison E ; ROCKSTROH, Jurgen ; VETS, Eva ; JOHNSON, Philip R ; ANKLESARIA, Pervin ; BARIN, Burc ; BOAZ, Mark ; KOCHHAR, Sonali</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c388t-b0c75203a8913786cd74e1f37f2c06c9d76a78dbe7ea5e6a26f43a126fa9bae33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>AIDS Vaccines - administration & dosage</topic><topic>AIDS Vaccines - adverse effects</topic><topic>AIDS/HIV</topic><topic>Antibody Formation</topic><topic>Biological and medical sciences</topic><topic>Capsid - immunology</topic><topic>Dependovirus - immunology</topic><topic>DNA, Viral - administration & dosage</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>gag Gene Products, Human Immunodeficiency Virus - immunology</topic><topic>Health aspects</topic><topic>HIV infection</topic><topic>HIV Infections - prevention & control</topic><topic>HIV-1 - immunology</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunity, Cellular</topic><topic>Immunization, Secondary</topic><topic>Infectious diseases</topic><topic>Injections, Intramuscular</topic><topic>Interferon-gamma - blood</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>Neutralization Tests</topic><topic>Physiological aspects</topic><topic>Prevention</topic><topic>T-Lymphocytes - immunology</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies</topic><topic>Vaccines, DNA - administration & dosage</topic><topic>Vaccines, DNA - adverse effects</topic><topic>Vaccines, DNA - immunology</topic><topic>Vaccines, Virosome - administration & dosage</topic><topic>Vaccines, Virosome - adverse effects</topic><topic>Viral diseases</topic><topic>Viral vaccines</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>MEHENDALE, Sanjay</creatorcontrib><creatorcontrib>VAN LUNZEN, Jan</creatorcontrib><creatorcontrib>LEHRMAN, Jennifer</creatorcontrib><creatorcontrib>SCHMIDT, Claudia</creatorcontrib><creatorcontrib>PEETERS, Mathieu</creatorcontrib><creatorcontrib>SCHWARZE-ZANDER, Carolynne</creatorcontrib><creatorcontrib>KABAMBA, Kabeya</creatorcontrib><creatorcontrib>GLAUNSINGER, Tobias</creatorcontrib><creatorcontrib>SAHAY, Seema</creatorcontrib><creatorcontrib>THAKAR, Madhuri</creatorcontrib><creatorcontrib>PARANJAPE, Ramesh</creatorcontrib><creatorcontrib>GILMOUR, Jill</creatorcontrib><creatorcontrib>CLUMECK, Nathan</creatorcontrib><creatorcontrib>EXCLER, Jean-Louis</creatorcontrib><creatorcontrib>FAST, Patricia</creatorcontrib><creatorcontrib>HEALD, Alison E</creatorcontrib><creatorcontrib>ROCKSTROH, Jurgen</creatorcontrib><creatorcontrib>VETS, Eva</creatorcontrib><creatorcontrib>JOHNSON, Philip R</creatorcontrib><creatorcontrib>ANKLESARIA, Pervin</creatorcontrib><creatorcontrib>BARIN, Burc</creatorcontrib><creatorcontrib>BOAZ, Mark</creatorcontrib><creatorcontrib>KOCHHAR, Sonali</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>AIDS research and human retroviruses</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>MEHENDALE, Sanjay</au><au>VAN LUNZEN, Jan</au><au>LEHRMAN, Jennifer</au><au>SCHMIDT, Claudia</au><au>PEETERS, Mathieu</au><au>SCHWARZE-ZANDER, Carolynne</au><au>KABAMBA, Kabeya</au><au>GLAUNSINGER, Tobias</au><au>SAHAY, Seema</au><au>THAKAR, Madhuri</au><au>PARANJAPE, Ramesh</au><au>GILMOUR, Jill</au><au>CLUMECK, Nathan</au><au>EXCLER, Jean-Louis</au><au>FAST, Patricia</au><au>HEALD, Alison E</au><au>ROCKSTROH, Jurgen</au><au>VETS, Eva</au><au>JOHNSON, Philip R</au><au>ANKLESARIA, Pervin</au><au>BARIN, Burc</au><au>BOAZ, Mark</au><au>KOCHHAR, Sonali</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Phase 1 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Subtype C Adeno-Associated Virus Vaccine</atitle><jtitle>AIDS research and human retroviruses</jtitle><addtitle>AIDS Res Hum Retroviruses</addtitle><date>2008-06-01</date><risdate>2008</risdate><volume>24</volume><issue>6</issue><spage>873</spage><epage>880</epage><pages>873-880</pages><issn>0889-2229</issn><eissn>1931-8405</eissn><coden>ARHRE7</coden><abstract>A novel prophylactic AIDS vaccine candidate, consisting of single-stranded DNA for HIV-1 subtype C gag, protease, and part of reverse transcriptase genes, enclosed within a recombinant adeno-associated virus serotype-2 protein capsid (tgAAC09) induced T cell responses and antibodies in nonhuman primates. In this randomized, dose escalation phase I trial, HIV-uninfected healthy volunteers (50 in Europe, 30 in India) received a single intramuscular injection of tgAAC09 at 3 x 10(9) DNase resistant particles (DRP) (n = 16), 3 x 10(10) DRP (n = 23), 3 x 10(11) DRP (n = 25), or placebo (n = 16). Twenty-one participants in Europe received a second (boost) dose of 3 x 10(11) DRP tgAAC09 or placebo at least 24 weeks after the first injection. The vaccine was safe and well-tolerated after initial and boost vaccination. Local and systemic reactogenicity was experienced by 13-25% of participants and was not dose related. No vaccine-related serious adverse events were reported. Modest HIV-specific T cell responses were detected in 7/64 vaccinees (40-385 SFC/10(6) PBMC), with 16% (4/25) responders in the highest dose group. All responses were to Gag epitopes. tgAAC09 appears to be safe, well-tolerated, and modestly immunogenic. Further evaluation of higher doses of tgAAC09 and boost injections is ongoing in Africa.</abstract><cop>Larchmont, NY</cop><pub>Liebert</pub><pmid>18544020</pmid><doi>10.1089/aid.2007.0292</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0889-2229 |
| ispartof | AIDS research and human retroviruses, 2008-06, Vol.24 (6), p.873-880 |
| issn | 0889-2229 1931-8405 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_69224265 |
| source | Mary Ann Liebert Online Subscription; MEDLINE; Alma/SFX Local Collection |
| subjects | Adolescent Adult AIDS Vaccines - administration & dosage AIDS Vaccines - adverse effects AIDS/HIV Antibody Formation Biological and medical sciences Capsid - immunology Dependovirus - immunology DNA, Viral - administration & dosage Double-Blind Method Female Fundamental and applied biological sciences. Psychology gag Gene Products, Human Immunodeficiency Virus - immunology Health aspects HIV infection HIV Infections - prevention & control HIV-1 - immunology Human viral diseases Humans Immunity, Cellular Immunization, Secondary Infectious diseases Injections, Intramuscular Interferon-gamma - blood Male Medical sciences Microbiology Middle Aged Miscellaneous Neutralization Tests Physiological aspects Prevention T-Lymphocytes - immunology Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies Vaccines, DNA - administration & dosage Vaccines, DNA - adverse effects Vaccines, DNA - immunology Vaccines, Virosome - administration & dosage Vaccines, Virosome - adverse effects Viral diseases Viral vaccines Virology |
| title | A Phase 1 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Subtype C Adeno-Associated Virus Vaccine |
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