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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 : 001739

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.
pA  
A01 01  1    @0 0934-9723
A03   1    @0 Eur. j. clin. microbiol. infect. dis. : (Print)
A05       @2 31
A06       @2 4
A08 01  1  ENG  @1 Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study
A11 01  1    @1 COLEMAN (B. L.)
A11 02  1    @1 KUSTER (S. P.)
A11 03  1    @1 GUBBAY (J.)
A11 04  1    @1 SCHEIFELE (D.)
A11 05  1    @1 LI (Y.)
A11 06  1    @1 LOW (D.)
A11 07  1    @1 CROWCROFT (N.)
A11 08  1    @1 MAZZULLI (T.)
A11 09  1    @1 SHI (L.)
A11 10  1    @1 HALPERIN (S. A.)
A11 11  1    @1 LAW (B.)
A11 12  1    @1 MCGEER (A.)
A14 01      @1 Department of Microbiology, Mount Sinai Hospital, 600 University Ave, Room 210 @2 Toronto, Ontario M5G 1X5 @3 CAN @Z 2 aut. @Z 6 aut. @Z 8 aut. @Z 12 aut.
A14 02      @1 University of Toronto @2 Toronto, Ontario @3 CAN @Z 1 aut. @Z 3 aut. @Z 6 aut. @Z 7 aut.
A14 03      @1 Ontario Agency of Health Promotion & Protection @2 Toronto, Ontario @3 CAN @Z 3 aut. @Z 6 aut. @Z 7 aut. @Z 9 aut.
A14 04      @1 University of British Columbia @2 Vancouver, British Columbia @3 CAN @Z 4 aut.
A14 05      @1 Child & Family Research Institute @2 Vancouver, British Columbia @3 CAN @Z 4 aut.
A14 06      @1 National Microbiology Laboratory @2 Winnipeg, Mannitoba @3 CAN @Z 5 aut.
A14 07      @1 Canadian Center for Vaccinology @2 Halifax, Nova Scotia @3 CAN @Z 10 aut.
A14 08      @1 Public Health Agency of Canada @2 Ottawa, Ontario @3 CAN @Z 11 aut.
A14 09      @1 Public Health Agency of Canada-Canadian Institutes of Health Research Influenza Research Network @2 Ottawa, Ontario @3 CAN @Z 4 aut. @Z 10 aut. @Z 11 aut. @Z 12 aut.
A20       @1 591-597
A21       @1 2012
A23 01      @0 ENG
A43 01      @1 INIST @2 19903 @5 354000509770090290
A44       @0 0000 @1 © 2012 INIST-CNRS. All rights reserved.
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A60       @1 P
A61       @0 A
A64 01  1    @0 European journal of clinical microbiology & infectious diseases : (Print)
A66 01      @0 DEU
C01 01    ENG  @0 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.
C02 01  X    @0 002B05C02C
C03 01  X  FRE  @0 Grippe A @5 01
C03 01  X  ENG  @0 Influenza A @5 01
C03 01  X  SPA  @0 Gripe A @5 01
C03 02  X  FRE  @0 Immunoprophylaxie @5 04
C03 02  X  ENG  @0 Immunoprophylaxis @5 04
C03 02  X  SPA  @0 Inmunoprofilaxia @5 04
C03 03  X  FRE  @0 Immunogénicité @5 07
C03 03  X  ENG  @0 Immunogenicity @5 07
C03 03  X  SPA  @0 Inmunogenicidad @5 07
C03 04  X  FRE  @0 Dose @5 08
C03 04  X  ENG  @0 Dose @5 08
C03 04  X  SPA  @0 Dosis @5 08
C03 05  X  FRE  @0 Prévention @5 09
C03 05  X  ENG  @0 Prevention @5 09
C03 05  X  SPA  @0 Prevención @5 09
C03 06  X  FRE  @0 Vaccin @5 13
C03 06  X  ENG  @0 Vaccine @5 13
C03 06  X  SPA  @0 Vacuna @5 13
C03 07  X  FRE  @0 Adulte @5 14
C03 07  X  ENG  @0 Adult @5 14
C03 07  X  SPA  @0 Adulto @5 14
C03 08  X  FRE  @0 Etude cohorte @5 15
C03 08  X  ENG  @0 Cohort study @5 15
C03 08  X  SPA  @0 Estudio cohorte @5 15
C03 09  X  FRE  @0 Microbiologie @5 17
C03 09  X  ENG  @0 Microbiology @5 17
C03 09  X  SPA  @0 Microbiología @5 17
C03 10  X  FRE  @0 Grippe H1N1 @4 CD @5 96
C03 10  X  ENG  @0 H1N1 influenza @4 CD @5 96
C03 10  X  SPA  @0 Gripe H1N1 @4 CD @5 96
C07 01  X  FRE  @0 Virose
C07 01  X  ENG  @0 Viral disease
C07 01  X  SPA  @0 Virosis
C07 02  X  FRE  @0 Infection
C07 02  X  ENG  @0 Infection
C07 02  X  SPA  @0 Infección
C07 03  X  FRE  @0 Homme
C07 03  X  ENG  @0 Human
C07 03  X  SPA  @0 Hombre
C07 04  X  FRE  @0 Pathologie de l'appareil respiratoire @5 37
C07 04  X  ENG  @0 Respiratory disease @5 37
C07 04  X  SPA  @0 Aparato respiratorio patología @5 37
N21       @1 135
N44 01      @1 OTO
N82       @1 OTO

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Pascal:12-0182435

Le document en format XML

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<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>
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