A double-blind, placebo-controlled study of the safety and immunogenicity of live, oral type 4 and type 7 adenovirus vaccines in adults
Abstract Adenovirus serotypes 4 (ADV-4) and 7 (ADV-7) are important causes of febrile acute respiratory disease (ARD) in US military recruits. Previously licensed vaccines, which effectively controlled adenovirus-associated ARD, are no longer available. In the Fall of 2004 we conducted this Phase 1...
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| Veröffentlicht in: | Vaccine 2008-06, Vol.26 (23), p.2890-2898 |
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| creator | Lyons, Arthur Longfield, Jenice Kuschner, Robert Straight, Timothy Binn, Leonard Seriwatana, Jitvimol Reitstetter, Raven Froh, Irma B Craft, David McNabb, Kevin Russell, Kevin Metzgar, David Liss, Alan Sun, Xiao Towle, Andrew Sun, Wellington |
| description | Abstract Adenovirus serotypes 4 (ADV-4) and 7 (ADV-7) are important causes of febrile acute respiratory disease (ARD) in US military recruits. Previously licensed vaccines, which effectively controlled adenovirus-associated ARD, are no longer available. In the Fall of 2004 we conducted this Phase 1 randomized, double-blind, placebo-controlled trial of the live, oral ADV-4 and ADV-7 vaccines made by a new manufacturer to assess their safety and immunogenicity. The adenovirus vaccines were administered orally together in a single dose to thirty subjects. Twenty eight additional subjects received placebo. Subjects were then observed for 8 weeks. The most commonly reported adverse events were nasal congestion (33%), cough (33%), sore throat (27%), headache (20%), abdominal pain (17%), arthralgia (13%), nausea (13%) and diarrhea (13%). None of these rates differed significantly from placebo. The duration of vaccine virus fecal shedding was 7–21 days. Seventy three percent of vaccine recipients seroconverted to ADV-4 (GMT 23.3) while 63% seroconverted to ADV-7 (GMT 51.1) by Day 28. The new ADV-4 and ADV-7 vaccines were safe and induced a good immune response in the study population. Expanded trials for safety and efficacy are in progress. |
| doi_str_mv | 10.1016/j.vaccine.2008.03.037 |
| format | Article |
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Previously licensed vaccines, which effectively controlled adenovirus-associated ARD, are no longer available. In the Fall of 2004 we conducted this Phase 1 randomized, double-blind, placebo-controlled trial of the live, oral ADV-4 and ADV-7 vaccines made by a new manufacturer to assess their safety and immunogenicity. The adenovirus vaccines were administered orally together in a single dose to thirty subjects. Twenty eight additional subjects received placebo. Subjects were then observed for 8 weeks. The most commonly reported adverse events were nasal congestion (33%), cough (33%), sore throat (27%), headache (20%), abdominal pain (17%), arthralgia (13%), nausea (13%) and diarrhea (13%). None of these rates differed significantly from placebo. The duration of vaccine virus fecal shedding was 7–21 days. Seventy three percent of vaccine recipients seroconverted to ADV-4 (GMT 23.3) while 63% seroconverted to ADV-7 (GMT 51.1) by Day 28. The new ADV-4 and ADV-7 vaccines were safe and induced a good immune response in the study population. Expanded trials for safety and efficacy are in progress.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2008.03.037</identifier><identifier>PMID: 18448211</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adenoviridae - immunology ; Adenoviridae Infections - immunology ; Adenoviridae Infections - prevention & control ; Adenoviridae Infections - virology ; Adenovirus ; Administration, Oral ; Adolescent ; Adult ; Allergy and Immunology ; Antibodies, Viral - analysis ; Antibodies, Viral - biosynthesis ; Applied microbiology ; Biological and medical sciences ; Double-Blind Method ; Feces - virology ; Female ; Fundamental and applied biological sciences. Psychology ; Humans ; Immune response ; Immunization ; Immunization, Secondary ; Immunogenicity ; Immunologic Surveillance ; Laboratories ; Live ; Male ; Microbiology ; Miscellaneous ; Oral ; Pharynx - virology ; Rectum - virology ; Respiratory diseases ; Reverse Transcriptase Polymerase Chain Reaction ; Safety ; Seeds ; Tablets, Enteric-Coated ; Type 4 ; Type 7 ; Vaccine ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Viral Vaccines - adverse effects ; Viral Vaccines - therapeutic use ; Viremia - blood ; Viremia - virology ; Virology ; Virus</subject><ispartof>Vaccine, 2008-06, Vol.26 (23), p.2890-2898</ispartof><rights>2008</rights><rights>2008 INIST-CNRS</rights><rights>Copyright Elsevier Limited Jun 2, 2008</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c507t-c86bf7e7ede79767673a4316285a06b6462c02b3210e8379ce0eba1bffaa1ce23</citedby><cites>FETCH-LOGICAL-c507t-c86bf7e7ede79767673a4316285a06b6462c02b3210e8379ce0eba1bffaa1ce23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0264410X08003708$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20359365$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18448211$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lyons, Arthur</creatorcontrib><creatorcontrib>Longfield, Jenice</creatorcontrib><creatorcontrib>Kuschner, Robert</creatorcontrib><creatorcontrib>Straight, Timothy</creatorcontrib><creatorcontrib>Binn, Leonard</creatorcontrib><creatorcontrib>Seriwatana, Jitvimol</creatorcontrib><creatorcontrib>Reitstetter, Raven</creatorcontrib><creatorcontrib>Froh, Irma B</creatorcontrib><creatorcontrib>Craft, David</creatorcontrib><creatorcontrib>McNabb, Kevin</creatorcontrib><creatorcontrib>Russell, Kevin</creatorcontrib><creatorcontrib>Metzgar, David</creatorcontrib><creatorcontrib>Liss, Alan</creatorcontrib><creatorcontrib>Sun, Xiao</creatorcontrib><creatorcontrib>Towle, Andrew</creatorcontrib><creatorcontrib>Sun, Wellington</creatorcontrib><title>A double-blind, placebo-controlled study of the safety and immunogenicity of live, oral type 4 and type 7 adenovirus vaccines in adults</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Abstract Adenovirus serotypes 4 (ADV-4) and 7 (ADV-7) are important causes of febrile acute respiratory disease (ARD) in US military recruits. Previously licensed vaccines, which effectively controlled adenovirus-associated ARD, are no longer available. In the Fall of 2004 we conducted this Phase 1 randomized, double-blind, placebo-controlled trial of the live, oral ADV-4 and ADV-7 vaccines made by a new manufacturer to assess their safety and immunogenicity. The adenovirus vaccines were administered orally together in a single dose to thirty subjects. Twenty eight additional subjects received placebo. Subjects were then observed for 8 weeks. The most commonly reported adverse events were nasal congestion (33%), cough (33%), sore throat (27%), headache (20%), abdominal pain (17%), arthralgia (13%), nausea (13%) and diarrhea (13%). None of these rates differed significantly from placebo. The duration of vaccine virus fecal shedding was 7–21 days. Seventy three percent of vaccine recipients seroconverted to ADV-4 (GMT 23.3) while 63% seroconverted to ADV-7 (GMT 51.1) by Day 28. The new ADV-4 and ADV-7 vaccines were safe and induced a good immune response in the study population. Expanded trials for safety and efficacy are in progress.</description><subject>Adenoviridae - immunology</subject><subject>Adenoviridae Infections - immunology</subject><subject>Adenoviridae Infections - prevention & control</subject><subject>Adenoviridae Infections - virology</subject><subject>Adenovirus</subject><subject>Administration, Oral</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Allergy and Immunology</subject><subject>Antibodies, Viral - analysis</subject><subject>Antibodies, Viral - biosynthesis</subject><subject>Applied microbiology</subject><subject>Biological and medical sciences</subject><subject>Double-Blind Method</subject><subject>Feces - virology</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Humans</subject><subject>Immune response</subject><subject>Immunization</subject><subject>Immunization, Secondary</subject><subject>Immunogenicity</subject><subject>Immunologic Surveillance</subject><subject>Laboratories</subject><subject>Live</subject><subject>Male</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Oral</subject><subject>Pharynx - virology</subject><subject>Rectum - virology</subject><subject>Respiratory diseases</subject><subject>Reverse Transcriptase Polymerase Chain Reaction</subject><subject>Safety</subject><subject>Seeds</subject><subject>Tablets, Enteric-Coated</subject><subject>Type 4</subject><subject>Type 7</subject><subject>Vaccine</subject><subject>Vaccines</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</subject><subject>Viral Vaccines - adverse effects</subject><subject>Viral Vaccines - therapeutic use</subject><subject>Viremia - blood</subject><subject>Viremia - virology</subject><subject>Virology</subject><subject>Virus</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkluL1DAUx4so7rr6EZSA6NN2PLm0SV-UZfEGCz6o4FtI01PNmEnGpB2YT-DXNjNTXNiXJQcSwu_8z7WqnlNYUaDtm_VqZ6x1AVcMQK2AF5MPqnOqJK9ZQ9XD6hxYK2pB4cdZ9STnNQA0nHaPqzOqhFCM0vPq7xUZ4tx7rHvvwnBJtt5Y7GNtY5hS9B4Hkqd52JM4kukXkmxGnPbEhIG4zWYO8ScGZ910BLzb4SWJyXgy7bdIxJE7PiUxA4a4c2nOZEk9ExfK9-yn_LR6NBqf8dlyX1TfP7z_dv2pvvny8fP11U1tG5BTbVXbjxIlDig72ZbDjeC0Zaox0PataJkF1nNGARWXnUXA3tB-HI2hFhm_qF6fdLcp_pkxT3rjskXvTcA4Zy1BtqJT4l6QQSeVkAfw5R1wHecUShGaNo1SVEjaFao5UTbFnBOOepvcxqS9pqAPA9VrvXRFHwaqgReTxe_Foj73GxxuvZYJFuDVAphsjR-TCdbl_xwD3nS8bQr37sRh6e7OYdLZOgwWB5fQTnqI7t5U3t5RsGVlXAn6G_eYb6vWmWnQXw_bd1g-UFDcQfF_SPDWPw</recordid><startdate>20080602</startdate><enddate>20080602</enddate><creator>Lyons, Arthur</creator><creator>Longfield, Jenice</creator><creator>Kuschner, Robert</creator><creator>Straight, Timothy</creator><creator>Binn, Leonard</creator><creator>Seriwatana, Jitvimol</creator><creator>Reitstetter, Raven</creator><creator>Froh, Irma B</creator><creator>Craft, David</creator><creator>McNabb, Kevin</creator><creator>Russell, Kevin</creator><creator>Metzgar, David</creator><creator>Liss, Alan</creator><creator>Sun, Xiao</creator><creator>Towle, Andrew</creator><creator>Sun, Wellington</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>AEUYN</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>Q9U</scope><scope>7U2</scope><scope>7X8</scope></search><sort><creationdate>20080602</creationdate><title>A double-blind, placebo-controlled study of the safety and immunogenicity of live, oral type 4 and type 7 adenovirus vaccines in adults</title><author>Lyons, Arthur ; Longfield, Jenice ; Kuschner, Robert ; Straight, Timothy ; Binn, Leonard ; Seriwatana, Jitvimol ; Reitstetter, Raven ; Froh, Irma B ; Craft, David ; McNabb, Kevin ; Russell, Kevin ; Metzgar, David ; Liss, Alan ; Sun, Xiao ; Towle, Andrew ; Sun, Wellington</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c507t-c86bf7e7ede79767673a4316285a06b6462c02b3210e8379ce0eba1bffaa1ce23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adenoviridae - immunology</topic><topic>Adenoviridae Infections - immunology</topic><topic>Adenoviridae Infections - prevention & control</topic><topic>Adenoviridae Infections - virology</topic><topic>Adenovirus</topic><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Allergy and Immunology</topic><topic>Antibodies, Viral - analysis</topic><topic>Antibodies, Viral - biosynthesis</topic><topic>Applied microbiology</topic><topic>Biological and medical sciences</topic><topic>Double-Blind Method</topic><topic>Feces - virology</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Humans</topic><topic>Immune response</topic><topic>Immunization</topic><topic>Immunization, Secondary</topic><topic>Immunogenicity</topic><topic>Immunologic Surveillance</topic><topic>Laboratories</topic><topic>Live</topic><topic>Male</topic><topic>Microbiology</topic><topic>Miscellaneous</topic><topic>Oral</topic><topic>Pharynx - virology</topic><topic>Rectum - virology</topic><topic>Respiratory diseases</topic><topic>Reverse Transcriptase Polymerase Chain Reaction</topic><topic>Safety</topic><topic>Seeds</topic><topic>Tablets, Enteric-Coated</topic><topic>Type 4</topic><topic>Type 7</topic><topic>Vaccine</topic><topic>Vaccines</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</topic><topic>Viral Vaccines - adverse effects</topic><topic>Viral Vaccines - therapeutic use</topic><topic>Viremia - blood</topic><topic>Viremia - 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immunogenicity of live, oral type 4 and type 7 adenovirus vaccines in adults</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2008-06-02</date><risdate>2008</risdate><volume>26</volume><issue>23</issue><spage>2890</spage><epage>2898</epage><pages>2890-2898</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><coden>VACCDE</coden><abstract>Abstract Adenovirus serotypes 4 (ADV-4) and 7 (ADV-7) are important causes of febrile acute respiratory disease (ARD) in US military recruits. Previously licensed vaccines, which effectively controlled adenovirus-associated ARD, are no longer available. In the Fall of 2004 we conducted this Phase 1 randomized, double-blind, placebo-controlled trial of the live, oral ADV-4 and ADV-7 vaccines made by a new manufacturer to assess their safety and immunogenicity. The adenovirus vaccines were administered orally together in a single dose to thirty subjects. Twenty eight additional subjects received placebo. Subjects were then observed for 8 weeks. The most commonly reported adverse events were nasal congestion (33%), cough (33%), sore throat (27%), headache (20%), abdominal pain (17%), arthralgia (13%), nausea (13%) and diarrhea (13%). None of these rates differed significantly from placebo. The duration of vaccine virus fecal shedding was 7–21 days. Seventy three percent of vaccine recipients seroconverted to ADV-4 (GMT 23.3) while 63% seroconverted to ADV-7 (GMT 51.1) by Day 28. The new ADV-4 and ADV-7 vaccines were safe and induced a good immune response in the study population. Expanded trials for safety and efficacy are in progress.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>18448211</pmid><doi>10.1016/j.vaccine.2008.03.037</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2008-06, Vol.26 (23), p.2890-2898 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_70764984 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adenoviridae - immunology Adenoviridae Infections - immunology Adenoviridae Infections - prevention & control Adenoviridae Infections - virology Adenovirus Administration, Oral Adolescent Adult Allergy and Immunology Antibodies, Viral - analysis Antibodies, Viral - biosynthesis Applied microbiology Biological and medical sciences Double-Blind Method Feces - virology Female Fundamental and applied biological sciences. Psychology Humans Immune response Immunization Immunization, Secondary Immunogenicity Immunologic Surveillance Laboratories Live Male Microbiology Miscellaneous Oral Pharynx - virology Rectum - virology Respiratory diseases Reverse Transcriptase Polymerase Chain Reaction Safety Seeds Tablets, Enteric-Coated Type 4 Type 7 Vaccine Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Viral Vaccines - adverse effects Viral Vaccines - therapeutic use Viremia - blood Viremia - virology Virology Virus |
| title | A double-blind, placebo-controlled study of the safety and immunogenicity of live, oral type 4 and type 7 adenovirus vaccines in adults |
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