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Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study

Identifieur interne : 002133 ( Main/Merge ); précédent : 002132; suivant : 002134

Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study

Auteurs : B. L. Coleman [Canada] ; S. P. Kuster [Canada] ; J. Gubbay [Canada] ; D. Scheifele [Canada] ; Y. Li [Canada] ; D. Low [Canada] ; N. Crowcroft [Canada] ; T. Mazzulli [Canada] ; L. Shi [Canada] ; S. A. Halperin [Canada] ; B. Law [Canada] ; A. Mcgeer [Canada]

Source :

RBID : Pascal:12-0182435

Descripteurs français

English descriptors

Abstract

We aimed to assess the immunogenicity of a single half-dose of AS03-adjuvanted monovalent 2009 pandemic H1N1 vaccine in healthy adults. Healthy subjects age 20-60 years were prospectively enrolled in a cohort receiving intramuscular administration of a single half-dose (1.875 μg of hemagglutinin [HA]) of adjuvanted 2009 pandemic H1N1 influenza vaccine. Data from participants enrolled in a concomitant study of immunogenicity following a full-dose (3.75 μg of HA) are presented concurrently. Sera for assessment of hemagglutination-inhibiting (HAI) antibody to the vaccine strain were obtained before and 14 or 21 days after vaccination. Ninety-seven participants received a half-dose and 50 received a full-dose of vaccine. In the half-dose cohort, Food and Drug Administration criteria for immunogenicity regarding seroprotection and seroconversion rates were met for subjects aged 20-45 years, but not for those aged 46-60 years. There was no statistically significant difference in the proportion of individuals achieving a post-vaccination HAI titre of ≥1:40, the geometric mean titres of post-vaccination antibody, or the proportion of individuals with a four-fold or greater increase in antibody levels between the two cohorts. Participants 46-60 years of age were significantly less likely to be seroprotected at day 21 than those 20-45 years old in both cohorts. Immunogenicity of a half dose of adjuvanted pH1N1 influenza vaccine was adequate in subjects aged 20-45 years. Dose reduction is a possible strategy for expanding the availability in the event of vaccine shortage in this age group.

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Pascal:12-0182435

Le document en format XML

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<title xml:lang="en" level="a">Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study</title>
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<author>
<name sortKey="Shi, L" sort="Shi, L" uniqKey="Shi L" first="L." last="Shi">L. Shi</name>
<affiliation wicri:level="1">
<inist:fA14 i1="03">
<s1>Ontario Agency of Health Promotion & Protection</s1>
<s2>Toronto, Ontario</s2>
<s3>CAN</s3>
<sZ>3 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Ontario Agency of Health Promotion & Protection</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Halperin, S A" sort="Halperin, S A" uniqKey="Halperin S" first="S. A." last="Halperin">S. A. Halperin</name>
<affiliation wicri:level="1">
<inist:fA14 i1="07">
<s1>Canadian Center for Vaccinology</s1>
<s2>Halifax, Nova Scotia</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Canadian Center for Vaccinology</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1">
<inist:fA14 i1="09">
<s1>Public Health Agency of Canada-Canadian Institutes of Health Research Influenza Research Network</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>4 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Public Health Agency of Canada-Canadian Institutes of Health Research Influenza Research Network</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Law, B" sort="Law, B" uniqKey="Law B" first="B." last="Law">B. Law</name>
<affiliation wicri:level="1">
<inist:fA14 i1="08">
<s1>Public Health Agency of Canada</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Public Health Agency of Canada</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1">
<inist:fA14 i1="09">
<s1>Public Health Agency of Canada-Canadian Institutes of Health Research Influenza Research Network</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>4 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Public Health Agency of Canada-Canadian Institutes of Health Research Influenza Research Network</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Mcgeer, A" sort="Mcgeer, A" uniqKey="Mcgeer A" first="A." last="Mcgeer">A. Mcgeer</name>
<affiliation wicri:level="1">
<inist:fA14 i1="01">
<s1>Department of Microbiology, Mount Sinai Hospital, 600 University Ave, Room 210</s1>
<s2>Toronto, Ontario M5G 1X5</s2>
<s3>CAN</s3>
<sZ>2 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Toronto, Ontario M5G 1X5</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1">
<inist:fA14 i1="09">
<s1>Public Health Agency of Canada-Canadian Institutes of Health Research Influenza Research Network</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>4 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Public Health Agency of Canada-Canadian Institutes of Health Research Influenza Research Network</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">European journal of clinical microbiology & infectious diseases : (Print)</title>
<title level="j" type="abbreviated">Eur. j. clin. microbiol. infect. dis. : (Print)</title>
<idno type="ISSN">0934-9723</idno>
<imprint>
<date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">European journal of clinical microbiology & infectious diseases : (Print)</title>
<title level="j" type="abbreviated">Eur. j. clin. microbiol. infect. dis. : (Print)</title>
<idno type="ISSN">0934-9723</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Adult</term>
<term>Cohort study</term>
<term>Dose</term>
<term>H1N1 influenza</term>
<term>Immunogenicity</term>
<term>Immunoprophylaxis</term>
<term>Influenza A</term>
<term>Microbiology</term>
<term>Prevention</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Grippe A</term>
<term>Immunoprophylaxie</term>
<term>Immunogénicité</term>
<term>Dose</term>
<term>Prévention</term>
<term>Vaccin</term>
<term>Adulte</term>
<term>Etude cohorte</term>
<term>Microbiologie</term>
<term>Grippe H1N1</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Vaccin</term>
<term>Adulte</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">We aimed to assess the immunogenicity of a single half-dose of AS03-adjuvanted monovalent 2009 pandemic H1N1 vaccine in healthy adults. Healthy subjects age 20-60 years were prospectively enrolled in a cohort receiving intramuscular administration of a single half-dose (1.875 μg of hemagglutinin [HA]) of adjuvanted 2009 pandemic H1N1 influenza vaccine. Data from participants enrolled in a concomitant study of immunogenicity following a full-dose (3.75 μg of HA) are presented concurrently. Sera for assessment of hemagglutination-inhibiting (HAI) antibody to the vaccine strain were obtained before and 14 or 21 days after vaccination. Ninety-seven participants received a half-dose and 50 received a full-dose of vaccine. In the half-dose cohort, Food and Drug Administration criteria for immunogenicity regarding seroprotection and seroconversion rates were met for subjects aged 20-45 years, but not for those aged 46-60 years. There was no statistically significant difference in the proportion of individuals achieving a post-vaccination HAI titre of ≥1:40, the geometric mean titres of post-vaccination antibody, or the proportion of individuals with a four-fold or greater increase in antibody levels between the two cohorts. Participants 46-60 years of age were significantly less likely to be seroprotected at day 21 than those 20-45 years old in both cohorts. Immunogenicity of a half dose of adjuvanted pH1N1 influenza vaccine was adequate in subjects aged 20-45 years. Dose reduction is a possible strategy for expanding the availability in the event of vaccine shortage in this age group.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Canada</li>
</country>
<region>
<li>Ontario</li>
</region>
<settlement>
<li>Toronto</li>
</settlement>
<orgName>
<li>Université de Toronto</li>
</orgName>
</list>
<tree>
<country name="Canada">
<region name="Ontario">
<name sortKey="Coleman, B L" sort="Coleman, B L" uniqKey="Coleman B" first="B. L." last="Coleman">B. L. Coleman</name>
</region>
<name sortKey="Crowcroft, N" sort="Crowcroft, N" uniqKey="Crowcroft N" first="N." last="Crowcroft">N. Crowcroft</name>
<name sortKey="Crowcroft, N" sort="Crowcroft, N" uniqKey="Crowcroft N" first="N." last="Crowcroft">N. Crowcroft</name>
<name sortKey="Gubbay, J" sort="Gubbay, J" uniqKey="Gubbay J" first="J." last="Gubbay">J. Gubbay</name>
<name sortKey="Gubbay, J" sort="Gubbay, J" uniqKey="Gubbay J" first="J." last="Gubbay">J. Gubbay</name>
<name sortKey="Halperin, S A" sort="Halperin, S A" uniqKey="Halperin S" first="S. A." last="Halperin">S. A. Halperin</name>
<name sortKey="Halperin, S A" sort="Halperin, S A" uniqKey="Halperin S" first="S. A." last="Halperin">S. A. Halperin</name>
<name sortKey="Kuster, S P" sort="Kuster, S P" uniqKey="Kuster S" first="S. P." last="Kuster">S. P. Kuster</name>
<name sortKey="Law, B" sort="Law, B" uniqKey="Law B" first="B." last="Law">B. Law</name>
<name sortKey="Law, B" sort="Law, B" uniqKey="Law B" first="B." last="Law">B. Law</name>
<name sortKey="Li, Y" sort="Li, Y" uniqKey="Li Y" first="Y." last="Li">Y. Li</name>
<name sortKey="Low, D" sort="Low, D" uniqKey="Low D" first="D." last="Low">D. Low</name>
<name sortKey="Low, D" sort="Low, D" uniqKey="Low D" first="D." last="Low">D. Low</name>
<name sortKey="Low, D" sort="Low, D" uniqKey="Low D" first="D." last="Low">D. Low</name>
<name sortKey="Mazzulli, T" sort="Mazzulli, T" uniqKey="Mazzulli T" first="T." last="Mazzulli">T. Mazzulli</name>
<name sortKey="Mcgeer, A" sort="Mcgeer, A" uniqKey="Mcgeer A" first="A." last="Mcgeer">A. Mcgeer</name>
<name sortKey="Mcgeer, A" sort="Mcgeer, A" uniqKey="Mcgeer A" first="A." last="Mcgeer">A. Mcgeer</name>
<name sortKey="Scheifele, D" sort="Scheifele, D" uniqKey="Scheifele D" first="D." last="Scheifele">D. Scheifele</name>
<name sortKey="Scheifele, D" sort="Scheifele, D" uniqKey="Scheifele D" first="D." last="Scheifele">D. Scheifele</name>
<name sortKey="Scheifele, D" sort="Scheifele, D" uniqKey="Scheifele D" first="D." last="Scheifele">D. Scheifele</name>
<name sortKey="Shi, L" sort="Shi, L" uniqKey="Shi L" first="L." last="Shi">L. Shi</name>
</country>
</tree>
</affiliations>
</record>

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