Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study
Identifieur interne : 001738 ( PascalFrancis/Curation ); précédent : 001737; suivant : 001739Immunogenicity 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 :
- European journal of clinical microbiology & infectious diseases : (Print) [ 0934-9723 ] ; 2012.
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English descriptors
- KwdEn :
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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<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>
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<term>Prévention</term>
<term>Vaccin</term>
<term>Adulte</term>
<term>Etude cohorte</term>
<term>Microbiologie</term>
<term>Grippe H1N1</term>
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<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>
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<fA03 i2="1"><s0>Eur. j. clin. microbiol. infect. dis. : (Print)</s0>
</fA03>
<fA05><s2>31</s2>
</fA05>
<fA06><s2>4</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>COLEMAN (B. L.)</s1>
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<fA11 i1="02" i2="1"><s1>KUSTER (S. P.)</s1>
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<fA11 i1="03" i2="1"><s1>GUBBAY (J.)</s1>
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<fA11 i1="04" i2="1"><s1>SCHEIFELE (D.)</s1>
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<fA11 i1="05" i2="1"><s1>LI (Y.)</s1>
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<fA11 i1="06" i2="1"><s1>LOW (D.)</s1>
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<fA11 i1="07" i2="1"><s1>CROWCROFT (N.)</s1>
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<fA11 i1="08" i2="1"><s1>MAZZULLI (T.)</s1>
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<fA11 i1="09" i2="1"><s1>SHI (L.)</s1>
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<fA11 i1="11" i2="1"><s1>LAW (B.)</s1>
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<fA11 i1="12" i2="1"><s1>MCGEER (A.)</s1>
</fA11>
<fA14 i1="01"><s1>Department of Microbiology, Mount Sinai Hospital, 600 University Ave, Room 210</s1>
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<sZ>6 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>12 aut.</sZ>
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<s3>CAN</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>6 aut.</sZ>
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<fA14 i1="03"><s1>Ontario Agency of Health Promotion & Protection</s1>
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<sZ>6 aut.</sZ>
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<s3>CAN</s3>
<sZ>4 aut.</sZ>
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<fA14 i1="05"><s1>Child & Family Research Institute</s1>
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<s3>CAN</s3>
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<fA14 i1="06"><s1>National Microbiology Laboratory</s1>
<s2>Winnipeg, Mannitoba</s2>
<s3>CAN</s3>
<sZ>5 aut.</sZ>
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<fA14 i1="07"><s1>Canadian Center for Vaccinology</s1>
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<s3>CAN</s3>
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<fA14 i1="08"><s1>Public Health Agency of Canada</s1>
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<fA14 i1="09"><s1>Public Health Agency of Canada-Canadian Institutes of Health Research Influenza Research Network</s1>
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<s3>CAN</s3>
<sZ>4 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
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<fA20><s1>591-597</s1>
</fA20>
<fA21><s1>2012</s1>
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<fA23 i1="01"><s0>ENG</s0>
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<fA43 i1="01"><s1>INIST</s1>
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<s5>354000509770090290</s5>
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<s1>© 2012 INIST-CNRS. All rights reserved.</s1>
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<fA47 i1="01" i2="1"><s0>12-0182435</s0>
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<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
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<fA64 i1="01" i2="1"><s0>European journal of clinical microbiology & infectious diseases : (Print)</s0>
</fA64>
<fA66 i1="01"><s0>DEU</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
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<fC02 i1="01" i2="X"><s0>002B05C02C</s0>
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<s5>01</s5>
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<fC03 i1="01" i2="X" l="ENG"><s0>Influenza A</s0>
<s5>01</s5>
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<s5>01</s5>
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<s5>04</s5>
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<fC03 i1="02" i2="X" l="ENG"><s0>Immunoprophylaxis</s0>
<s5>04</s5>
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<s5>04</s5>
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<s5>07</s5>
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<s5>07</s5>
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<s5>07</s5>
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<fC03 i1="04" i2="X" l="FRE"><s0>Dose</s0>
<s5>08</s5>
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<s5>08</s5>
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<s5>08</s5>
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<s5>14</s5>
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<s5>14</s5>
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<fC03 i1="08" i2="X" l="FRE"><s0>Etude cohorte</s0>
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<fC03 i1="08" i2="X" l="ENG"><s0>Cohort study</s0>
<s5>15</s5>
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<s5>15</s5>
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<fC03 i1="10" i2="X" l="FRE"><s0>Grippe H1N1</s0>
<s4>CD</s4>
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<s4>CD</s4>
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