Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19–64 years of age
Abstract Purpose This study was conducted to assess the immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine containing three pertussis antigens ( Boostrix® , Tdap3v), currently licensed in the US for use in adolescents 10–18 years of age,...
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description | Abstract Purpose This study was conducted to assess the immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine containing three pertussis antigens ( Boostrix® , Tdap3v), currently licensed in the US for use in adolescents 10–18 years of age, in adults 19–64 years of age. Methods 2284 healthy adults, aged 19–64 years, were randomized to receive a single dose of Tdap vaccine, either Tdap3v or a five-pertussis component Tdap vaccine ( Adacel® , Tdap5v) licensed for adult use in the US. Blood samples were taken before and 1 month after vaccination. Reactogenicity was assessed for 15 days after vaccination. Results Tdap3v was comparable to Tdap5v in eliciting seroprotective levels of antibodies to diphtheria and tetanus toxoids, with >98% of subjects having post-vaccination seroprotective antibody levels (≥0.1 IU/mL) against diphtheria or tetanus toxoids. The pertussis components of Tdap3v were shown to be immunogenic in adults, with booster responses to pertussis toxoid (PT), filamentous hemagglutinin (FHA), and pertactin (PRN) observed in 77.2%, 96.9%, and 93.2%, respectively, of Tdap3v recipients, and in 47.1%, 94.0%, and 91.7%, respectively, of Tdap5v recipients. Anti-pertussis antibody GMCs in Tdap3v recipients exceeded those observed in infants following primary DTaP vaccination, in whom efficacy against pertussis disease was subsequently demonstrated. Injection site reactions (pain, redness, and swelling) and fever ≥37.5 °C (99.5 °F) were reported significantly more often ( p < 0.05) by Tdap5v recipients than by Tdap3v recipients. Fatigue preventing normal daily activities was reported by a small but significantly greater percentage of Tdap3v recipients (2.5%) than Tdap5v recipients (1.2%, p < 0.05). Conclusion In adult recipients, Tdap3v was comparable to an approved Tdap vaccine in providing seroprotection against diphtheria and tetanus, and produced immune responses to pertussis antigens consistent with protection against disease. The overall safety profile of Tdap3v was generally comparable to that of Tdap5v [NCT #106316]. |
doi_str_mv | 10.1016/j.vaccine.2008.11.028 |
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Methods 2284 healthy adults, aged 19–64 years, were randomized to receive a single dose of Tdap vaccine, either Tdap3v or a five-pertussis component Tdap vaccine ( Adacel® , Tdap5v) licensed for adult use in the US. Blood samples were taken before and 1 month after vaccination. Reactogenicity was assessed for 15 days after vaccination. Results Tdap3v was comparable to Tdap5v in eliciting seroprotective levels of antibodies to diphtheria and tetanus toxoids, with >98% of subjects having post-vaccination seroprotective antibody levels (≥0.1 IU/mL) against diphtheria or tetanus toxoids. The pertussis components of Tdap3v were shown to be immunogenic in adults, with booster responses to pertussis toxoid (PT), filamentous hemagglutinin (FHA), and pertactin (PRN) observed in 77.2%, 96.9%, and 93.2%, respectively, of Tdap3v recipients, and in 47.1%, 94.0%, and 91.7%, respectively, of Tdap5v recipients. Anti-pertussis antibody GMCs in Tdap3v recipients exceeded those observed in infants following primary DTaP vaccination, in whom efficacy against pertussis disease was subsequently demonstrated. Injection site reactions (pain, redness, and swelling) and fever ≥37.5 °C (99.5 °F) were reported significantly more often ( p < 0.05) by Tdap5v recipients than by Tdap3v recipients. Fatigue preventing normal daily activities was reported by a small but significantly greater percentage of Tdap3v recipients (2.5%) than Tdap5v recipients (1.2%, p < 0.05). Conclusion In adult recipients, Tdap3v was comparable to an approved Tdap vaccine in providing seroprotection against diphtheria and tetanus, and produced immune responses to pertussis antigens consistent with protection against disease. The overall safety profile of Tdap3v was generally comparable to that of Tdap5v [NCT #106316].</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2008.11.028</identifier><identifier>PMID: 19041352</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adult ; Age ; Allergy and Immunology ; Antibodies, Bacterial - blood ; Antigens ; Applied microbiology ; Bacterial diseases ; Biological and medical sciences ; Booster immunization ; Confidence intervals ; Diphtheria ; Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects ; Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology ; Diphtheria–tetanus–acellular pertussis vaccines ; Ent and stomatologic bacterial diseases ; Fatigue - chemically induced ; Female ; Fever - chemically induced ; Fundamental and applied biological sciences. Psychology ; Human bacterial diseases ; Humans ; Immunization, Secondary ; Immunogenicity ; Infectious diseases ; Licenses ; Male ; Medical sciences ; Microbiology ; Middle Aged ; Pain - chemically induced ; Postpartum period ; Safety ; Teenagers ; Tetanus ; United States ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Womens health ; Young Adult</subject><ispartof>Vaccine, 2009-01, Vol.27 (5), p.765-772</ispartof><rights>Elsevier Ltd</rights><rights>2008 Elsevier Ltd</rights><rights>2009 INIST-CNRS</rights><rights>Copyright Elsevier Limited Jan 29, 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c507t-561940adee9d7b45a0cdff1d0e59ee0465687737c328ef7fbea189263c9e76753</citedby><cites>FETCH-LOGICAL-c507t-561940adee9d7b45a0cdff1d0e59ee0465687737c328ef7fbea189263c9e76753</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1618825658?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21103664$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19041352$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Blatter, Mark</creatorcontrib><creatorcontrib>Friedland, Leonard R</creatorcontrib><creatorcontrib>Weston, Wayde M</creatorcontrib><creatorcontrib>Li, Ping</creatorcontrib><creatorcontrib>Howe, Barbara</creatorcontrib><title>Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19–64 years of age</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Abstract Purpose This study was conducted to assess the immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine containing three pertussis antigens ( Boostrix® , Tdap3v), currently licensed in the US for use in adolescents 10–18 years of age, in adults 19–64 years of age. Methods 2284 healthy adults, aged 19–64 years, were randomized to receive a single dose of Tdap vaccine, either Tdap3v or a five-pertussis component Tdap vaccine ( Adacel® , Tdap5v) licensed for adult use in the US. Blood samples were taken before and 1 month after vaccination. Reactogenicity was assessed for 15 days after vaccination. Results Tdap3v was comparable to Tdap5v in eliciting seroprotective levels of antibodies to diphtheria and tetanus toxoids, with >98% of subjects having post-vaccination seroprotective antibody levels (≥0.1 IU/mL) against diphtheria or tetanus toxoids. The pertussis components of Tdap3v were shown to be immunogenic in adults, with booster responses to pertussis toxoid (PT), filamentous hemagglutinin (FHA), and pertactin (PRN) observed in 77.2%, 96.9%, and 93.2%, respectively, of Tdap3v recipients, and in 47.1%, 94.0%, and 91.7%, respectively, of Tdap5v recipients. Anti-pertussis antibody GMCs in Tdap3v recipients exceeded those observed in infants following primary DTaP vaccination, in whom efficacy against pertussis disease was subsequently demonstrated. Injection site reactions (pain, redness, and swelling) and fever ≥37.5 °C (99.5 °F) were reported significantly more often ( p < 0.05) by Tdap5v recipients than by Tdap3v recipients. Fatigue preventing normal daily activities was reported by a small but significantly greater percentage of Tdap3v recipients (2.5%) than Tdap5v recipients (1.2%, p < 0.05). Conclusion In adult recipients, Tdap3v was comparable to an approved Tdap vaccine in providing seroprotection against diphtheria and tetanus, and produced immune responses to pertussis antigens consistent with protection against disease. The overall safety profile of Tdap3v was generally comparable to that of Tdap5v [NCT #106316].</description><subject>Adult</subject><subject>Age</subject><subject>Allergy and Immunology</subject><subject>Antibodies, Bacterial - blood</subject><subject>Antigens</subject><subject>Applied microbiology</subject><subject>Bacterial diseases</subject><subject>Biological and medical sciences</subject><subject>Booster immunization</subject><subject>Confidence intervals</subject><subject>Diphtheria</subject><subject>Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects</subject><subject>Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology</subject><subject>Diphtheria–tetanus–acellular pertussis vaccines</subject><subject>Ent and stomatologic bacterial diseases</subject><subject>Fatigue - chemically induced</subject><subject>Female</subject><subject>Fever - chemically induced</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Human bacterial diseases</subject><subject>Humans</subject><subject>Immunization, Secondary</subject><subject>Immunogenicity</subject><subject>Infectious diseases</subject><subject>Licenses</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Middle Aged</subject><subject>Pain - chemically induced</subject><subject>Postpartum period</subject><subject>Safety</subject><subject>Teenagers</subject><subject>Tetanus</subject><subject>United States</subject><subject>Vaccines</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</subject><subject>Womens health</subject><subject>Young Adult</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFks9u1DAQxiMEokvhEUCWED2RxePETnIBoYo_lSpxAKTeLK896XpJ7K3tVN0b78CB9-NJ8HYjKvXCyZb8-8bfzDdF8RzoEiiIN5vltdLaOlwyStslwJKy9kGxgLapSsahfVgsKBN1WQO9OCqexLihlPIKusfFEXS0hoqzRfH7bBwn5y_RWW3TjihnSFQ95qvviSIJk3JTJMnfeGtek4Bm0miIsdt1WmOwan66VaZ1QCy1H7feoUtEaRyGaVCBbDGkKUYbyWybWEeUmYYUCXR_fv4SNdmhCvH220t8Wjzq1RDx2XweF98_fvh2-rk8__Lp7PT9eak5bVLJBXQ1VQaxM82q5opq0_dgKPIOkdaCi7ZpqkZXrMW-6VeooO2YqHSHjWh4dVycHOpug7-aMCY52rh3rRz6KUpGq44x3mTw5T1w46fgsjcJAtqWccHbTPEDpYOPMWAvt8GOKuwkULnPTW7kPAC5z00CyJxb1r2Yq0-rEc2dag4qA69mQEWthj4op238xzEAWglRZ-7dgcM8tGuLQUZt0eXIbECdpPH2v1be3qugB5u3Qw0_cIfxrmsZmaTy637J9jtGWwqcw0X1F21c0Gc</recordid><startdate>20090129</startdate><enddate>20090129</enddate><creator>Blatter, Mark</creator><creator>Friedland, Leonard R</creator><creator>Weston, Wayde M</creator><creator>Li, Ping</creator><creator>Howe, Barbara</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>Q9U</scope><scope>7U2</scope></search><sort><creationdate>20090129</creationdate><title>Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19–64 years of age</title><author>Blatter, Mark ; Friedland, Leonard R ; Weston, Wayde M ; Li, Ping ; Howe, Barbara</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c507t-561940adee9d7b45a0cdff1d0e59ee0465687737c328ef7fbea189263c9e76753</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adult</topic><topic>Age</topic><topic>Allergy and Immunology</topic><topic>Antibodies, Bacterial - blood</topic><topic>Antigens</topic><topic>Applied microbiology</topic><topic>Bacterial diseases</topic><topic>Biological and medical sciences</topic><topic>Booster immunization</topic><topic>Confidence intervals</topic><topic>Diphtheria</topic><topic>Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects</topic><topic>Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology</topic><topic>Diphtheria–tetanus–acellular pertussis vaccines</topic><topic>Ent and stomatologic bacterial diseases</topic><topic>Fatigue - chemically induced</topic><topic>Female</topic><topic>Fever - chemically induced</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Human bacterial diseases</topic><topic>Humans</topic><topic>Immunization, Secondary</topic><topic>Immunogenicity</topic><topic>Infectious diseases</topic><topic>Licenses</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Middle Aged</topic><topic>Pain - chemically induced</topic><topic>Postpartum period</topic><topic>Safety</topic><topic>Teenagers</topic><topic>Tetanus</topic><topic>United States</topic><topic>Vaccines</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</topic><topic>Womens health</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Blatter, Mark</creatorcontrib><creatorcontrib>Friedland, Leonard R</creatorcontrib><creatorcontrib>Weston, Wayde M</creatorcontrib><creatorcontrib>Li, Ping</creatorcontrib><creatorcontrib>Howe, 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Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>Safety Science and Risk</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Blatter, Mark</au><au>Friedland, Leonard R</au><au>Weston, Wayde M</au><au>Li, Ping</au><au>Howe, Barbara</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19–64 years of age</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2009-01-29</date><risdate>2009</risdate><volume>27</volume><issue>5</issue><spage>765</spage><epage>772</epage><pages>765-772</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><coden>VACCDE</coden><abstract>Abstract Purpose This study was conducted to assess the immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine containing three pertussis antigens ( Boostrix® , Tdap3v), currently licensed in the US for use in adolescents 10–18 years of age, in adults 19–64 years of age. Methods 2284 healthy adults, aged 19–64 years, were randomized to receive a single dose of Tdap vaccine, either Tdap3v or a five-pertussis component Tdap vaccine ( Adacel® , Tdap5v) licensed for adult use in the US. Blood samples were taken before and 1 month after vaccination. Reactogenicity was assessed for 15 days after vaccination. Results Tdap3v was comparable to Tdap5v in eliciting seroprotective levels of antibodies to diphtheria and tetanus toxoids, with >98% of subjects having post-vaccination seroprotective antibody levels (≥0.1 IU/mL) against diphtheria or tetanus toxoids. The pertussis components of Tdap3v were shown to be immunogenic in adults, with booster responses to pertussis toxoid (PT), filamentous hemagglutinin (FHA), and pertactin (PRN) observed in 77.2%, 96.9%, and 93.2%, respectively, of Tdap3v recipients, and in 47.1%, 94.0%, and 91.7%, respectively, of Tdap5v recipients. Anti-pertussis antibody GMCs in Tdap3v recipients exceeded those observed in infants following primary DTaP vaccination, in whom efficacy against pertussis disease was subsequently demonstrated. Injection site reactions (pain, redness, and swelling) and fever ≥37.5 °C (99.5 °F) were reported significantly more often ( p < 0.05) by Tdap5v recipients than by Tdap3v recipients. Fatigue preventing normal daily activities was reported by a small but significantly greater percentage of Tdap3v recipients (2.5%) than Tdap5v recipients (1.2%, p < 0.05). Conclusion In adult recipients, Tdap3v was comparable to an approved Tdap vaccine in providing seroprotection against diphtheria and tetanus, and produced immune responses to pertussis antigens consistent with protection against disease. The overall safety profile of Tdap3v was generally comparable to that of Tdap5v [NCT #106316].</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>19041352</pmid><doi>10.1016/j.vaccine.2008.11.028</doi><tpages>8</tpages></addata></record> |
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subjects | Adult Age Allergy and Immunology Antibodies, Bacterial - blood Antigens Applied microbiology Bacterial diseases Biological and medical sciences Booster immunization Confidence intervals Diphtheria Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology Diphtheria–tetanus–acellular pertussis vaccines Ent and stomatologic bacterial diseases Fatigue - chemically induced Female Fever - chemically induced Fundamental and applied biological sciences. Psychology Human bacterial diseases Humans Immunization, Secondary Immunogenicity Infectious diseases Licenses Male Medical sciences Microbiology Middle Aged Pain - chemically induced Postpartum period Safety Teenagers Tetanus United States Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Womens health Young Adult |
title | Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19–64 years of age |
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