Safety and Immunogenicity of a Dengue Virus Serotype-1 Purified-Inactivated Vaccine: Results of a Phase 1 Clinical Trial
We describe the results from a human clinical trial of a dengue virus serotype-1, purified-inactivated vaccine (DENV-1 PIV) adjuvanted with aluminum hydroxide. This first-in-man, Phase 1, open-label clinical trial consisted of two groups of flavivirus-naïve healthy adult volunteers that received two...
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| Veröffentlicht in: | The American journal of tropical medicine and hygiene 2015-09, Vol.93 (3), p.454-460 |
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| creator | Martinez, Luis Javier Lin, Leyi Blaylock, Jason M Lyons, Arthur G Bauer, Kristen M De La Barrera, Rafael Simmons, Monika Jarman, Richard G Currier, Jeffrey R Friberg, Heather Danko, Janine R Teneza-Mora, Nimfa C Putnak, J Robert Eckels, Kenneth H Thomas, Stephen J |
| description | We describe the results from a human clinical trial of a dengue virus serotype-1, purified-inactivated vaccine (DENV-1 PIV) adjuvanted with aluminum hydroxide. This first-in-man, Phase 1, open-label clinical trial consisted of two groups of flavivirus-naïve healthy adult volunteers that received two intramuscular vaccine doses of either 2.5 μg or 5 μg of DENV-1 PIV administered on days 0 and 28. Following vaccination, both vaccine doses exhibited an acceptable safety profile with minimal injection site and systemic reactions. By study day 42, 2 weeks following the second vaccine dose, all volunteers in both vaccine groups developed serum-neutralizing antibodies against DENV-1. Additional testing using an enzyme-linked immunosorbent assay demonstrated induction of a humoral immune response following both vaccine doses. The DENV-1 PIV was safe and immunogenic in a small number of volunteers supporting development and further testing of a tetravalent DENV PIV formulation. |
| doi_str_mv | 10.4269/ajtmh.14-0819 |
| format | Article |
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This first-in-man, Phase 1, open-label clinical trial consisted of two groups of flavivirus-naïve healthy adult volunteers that received two intramuscular vaccine doses of either 2.5 μg or 5 μg of DENV-1 PIV administered on days 0 and 28. Following vaccination, both vaccine doses exhibited an acceptable safety profile with minimal injection site and systemic reactions. By study day 42, 2 weeks following the second vaccine dose, all volunteers in both vaccine groups developed serum-neutralizing antibodies against DENV-1. Additional testing using an enzyme-linked immunosorbent assay demonstrated induction of a humoral immune response following both vaccine doses. The DENV-1 PIV was safe and immunogenic in a small number of volunteers supporting development and further testing of a tetravalent DENV PIV formulation.</description><identifier>ISSN: 0002-9637</identifier><identifier>EISSN: 1476-1645</identifier><identifier>DOI: 10.4269/ajtmh.14-0819</identifier><identifier>PMID: 26149862</identifier><language>eng</language><publisher>United States: The American Society of Tropical Medicine and Hygiene</publisher><subject>Adolescent ; Adult ; Antibodies, Neutralizing - immunology ; Antibodies, Viral - immunology ; Dengue Vaccines - administration & dosage ; Dengue Vaccines - adverse effects ; Dengue Vaccines - immunology ; Dengue Vaccines - therapeutic use ; Dengue virus ; Dengue Virus - immunology ; Enzyme-Linked Immunosorbent Assay ; Female ; Flaviviridae ; Humans ; Immunoglobulin G - immunology ; Immunoglobulin M - immunology ; Male ; Middle Aged ; Vaccines, Inactivated - adverse effects ; Vaccines, Inactivated - immunology ; Vaccines, Inactivated - therapeutic use ; Young Adult</subject><ispartof>The American journal of tropical medicine and hygiene, 2015-09, Vol.93 (3), p.454-460</ispartof><rights>The American Society of Tropical Medicine and Hygiene.</rights><rights>The American Society of Tropical Medicine and Hygiene 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c420t-495ba4763ec250fdcc6bfc4a3aa22c7182074f47ff56a78e6aa88dc40c7d7faa3</citedby><cites>FETCH-LOGICAL-c420t-495ba4763ec250fdcc6bfc4a3aa22c7182074f47ff56a78e6aa88dc40c7d7faa3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4559679/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4559679/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27923,27924,53790,53792</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26149862$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Martinez, Luis Javier</creatorcontrib><creatorcontrib>Lin, Leyi</creatorcontrib><creatorcontrib>Blaylock, Jason M</creatorcontrib><creatorcontrib>Lyons, Arthur G</creatorcontrib><creatorcontrib>Bauer, Kristen M</creatorcontrib><creatorcontrib>De La Barrera, Rafael</creatorcontrib><creatorcontrib>Simmons, Monika</creatorcontrib><creatorcontrib>Jarman, Richard G</creatorcontrib><creatorcontrib>Currier, Jeffrey R</creatorcontrib><creatorcontrib>Friberg, Heather</creatorcontrib><creatorcontrib>Danko, Janine R</creatorcontrib><creatorcontrib>Teneza-Mora, Nimfa C</creatorcontrib><creatorcontrib>Putnak, J Robert</creatorcontrib><creatorcontrib>Eckels, Kenneth H</creatorcontrib><creatorcontrib>Thomas, Stephen J</creatorcontrib><title>Safety and Immunogenicity of a Dengue Virus Serotype-1 Purified-Inactivated Vaccine: Results of a Phase 1 Clinical Trial</title><title>The American journal of tropical medicine and hygiene</title><addtitle>Am J Trop Med Hyg</addtitle><description>We describe the results from a human clinical trial of a dengue virus serotype-1, purified-inactivated vaccine (DENV-1 PIV) adjuvanted with aluminum hydroxide. 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This first-in-man, Phase 1, open-label clinical trial consisted of two groups of flavivirus-naïve healthy adult volunteers that received two intramuscular vaccine doses of either 2.5 μg or 5 μg of DENV-1 PIV administered on days 0 and 28. Following vaccination, both vaccine doses exhibited an acceptable safety profile with minimal injection site and systemic reactions. By study day 42, 2 weeks following the second vaccine dose, all volunteers in both vaccine groups developed serum-neutralizing antibodies against DENV-1. Additional testing using an enzyme-linked immunosorbent assay demonstrated induction of a humoral immune response following both vaccine doses. The DENV-1 PIV was safe and immunogenic in a small number of volunteers supporting development and further testing of a tetravalent DENV PIV formulation.</abstract><cop>United States</cop><pub>The American Society of Tropical Medicine and Hygiene</pub><pmid>26149862</pmid><doi>10.4269/ajtmh.14-0819</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Antibodies, Neutralizing - immunology Antibodies, Viral - immunology Dengue Vaccines - administration & dosage Dengue Vaccines - adverse effects Dengue Vaccines - immunology Dengue Vaccines - therapeutic use Dengue virus Dengue Virus - immunology Enzyme-Linked Immunosorbent Assay Female Flaviviridae Humans Immunoglobulin G - immunology Immunoglobulin M - immunology Male Middle Aged Vaccines, Inactivated - adverse effects Vaccines, Inactivated - immunology Vaccines, Inactivated - therapeutic use Young Adult |
| title | Safety and Immunogenicity of a Dengue Virus Serotype-1 Purified-Inactivated Vaccine: Results of a Phase 1 Clinical Trial |
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