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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Veröffentlicht in:Vaccine 2009-01, Vol.27 (5), p.765-772
Hauptverfasser: Blatter, Mark, Friedland, Leonard R, Weston, Wayde M, Li, Ping, Howe, Barbara
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container_title Vaccine
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creator Blatter, Mark
Friedland, Leonard R
Weston, Wayde M
Li, Ping
Howe, Barbara
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 &gt;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 &lt; 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 &lt; 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>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=21103664$$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 &gt;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 &lt; 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 &lt; 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, Barbara</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>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Family Health Database (Proquest)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>ProQuest Health Management</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest research library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>ProQuest Biological Science Journals</collection><collection>Research Library (Corporate)</collection><collection>Nursing &amp; 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 &gt;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 &lt; 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 &lt; 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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1873-2518
language eng
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source MEDLINE; Elsevier ScienceDirect Journals Complete; ProQuest Central
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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