Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons
Identifieur interne : 000525 ( PascalFrancis/Corpus ); précédent : 000524; suivant : 000526Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons
Auteurs : Lisa A. Jackson ; Wilbur H. Chen ; Jack T. Stapleton ; Cornelia L. Dekker ; Anna Wald ; Rebecca C. Brady ; Srilatha Edupuganti ; Patricia Winokur ; Mark J. Mulligan ; Harry L. Keyserling ; Karen L. Kotloff ; Nadine Rouphael ; Diana L. Noah ; Heather Hill ; Mark C. WolffSource :
- The Journal of infectious diseases [ 0022-1899 ] ; 2012.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.
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Pour connaître la documentation sur le format Inist Standard.
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Format Inist (serveur)
NO : | PASCAL 12-0371820 INIST |
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ET : | Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons |
AU : | JACKSON (Lisa A.); CHEN (Wilbur H.); STAPLETON (Jack T.); DEKKER (Cornelia L.); WALD (Anna); BRADY (Rebecca C.); EDUPUGANTI (Srilatha); WINOKUR (Patricia); MULLIGAN (Mark J.); KEYSERLING (Harry L.); KOTLOFF (Karen L.); ROUPHAEL (Nadine); NOAH (Diana L.); HILL (Heather); WOLFF (Mark C.) |
AF : | Group Health Research Institute and/Etats-Unis (1 aut.); University of Washington, Seattle/Washington, Maryland/Etats-Unis (5 aut.); Center for Vaccine Development, University of Maryland School of Medicine/Baltimore/Etats-Unis (2 aut., 11 aut.); The EMMES Corporation/Rockville, Maryland/Etats-Unis (14 aut., 15 aut.); University of Iowa Carver College of Medicine and the Iowa City VA Healthcare System/Iowa City, Iowa/Etats-Unis (3 aut., 8 aut.); Stanford University School of Medicine/Stanford, California/Etats-Unis (4 aut.); Cincinnati Children's Hospital Medical Center/Cincinnati, Ohio/Etats-Unis (6 aut.); Emory University School of Medicine/Atlanta, Georgia/Etats-Unis (7 aut., 9 aut., 10 aut., 12 aut.); Southern Research Institute/Birmingham, Alabama/Etats-Unis (13 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | The Journal of infectious diseases; ISSN 0022-1899; Coden JIDIAQ; Royaume-Uni; Da. 2012; Vol. 206; No. 6; Pp. 811-820; Bibl. 34 ref. |
LA : | Anglais |
EA : | Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated. |
CC : | 002A05C10; 002B05; 002A05F04 |
FD : | Virus grippal A; Homme; Immunogénicité; Vaccin; Adjuvant immunologique; Personne âgée; Infection; Grippe A |
FG : | Influenzavirus A; Orthomyxoviridae; Virus; Virose |
ED : | Influenza A virus; Human; Immunogenicity; Vaccine; Immunological adjuvant; Elderly; Infection; Influenza A |
EG : | Influenzavirus A; Orthomyxoviridae; Virus; Viral disease |
SD : | Influenza A virus; Hombre; Inmunogenicidad; Vacuna; Coadyuvante inmunológico; Anciano; Infección; Gripe A |
LO : | INIST-2052.354000509502200040 |
ID : | 12-0371820 |
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Pascal:12-0371820Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons</title>
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<author><name sortKey="Winokur, Patricia" sort="Winokur, Patricia" uniqKey="Winokur P" first="Patricia" last="Winokur">Patricia Winokur</name>
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<author><name sortKey="Kotloff, Karen L" sort="Kotloff, Karen L" uniqKey="Kotloff K" first="Karen L." last="Kotloff">Karen L. Kotloff</name>
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<author><name sortKey="Rouphael, Nadine" sort="Rouphael, Nadine" uniqKey="Rouphael N" first="Nadine" last="Rouphael">Nadine Rouphael</name>
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<author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name>
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<author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name>
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<author><name sortKey="Wolff, Mark C" sort="Wolff, Mark C" uniqKey="Wolff M" first="Mark C." last="Wolff">Mark C. Wolff</name>
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<series><title level="j" type="main">The Journal of infectious diseases</title>
<title level="j" type="abbreviated">J. infect. dis.</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Elderly</term>
<term>Human</term>
<term>Immunogenicity</term>
<term>Immunological adjuvant</term>
<term>Infection</term>
<term>Influenza A</term>
<term>Influenza A virus</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Virus grippal A</term>
<term>Homme</term>
<term>Immunogénicité</term>
<term>Vaccin</term>
<term>Adjuvant immunologique</term>
<term>Personne âgée</term>
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<front><div type="abstract" xml:lang="en">Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.</div>
</front>
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<fA11 i1="01" i2="1"><s1>JACKSON (Lisa A.)</s1>
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<fA11 i1="06" i2="1"><s1>BRADY (Rebecca C.)</s1>
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<fA11 i1="07" i2="1"><s1>EDUPUGANTI (Srilatha)</s1>
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<fA11 i1="08" i2="1"><s1>WINOKUR (Patricia)</s1>
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<fA11 i1="09" i2="1"><s1>MULLIGAN (Mark J.)</s1>
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<fA11 i1="12" i2="1"><s1>ROUPHAEL (Nadine)</s1>
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<fA11 i1="13" i2="1"><s1>NOAH (Diana L.)</s1>
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<fA11 i1="14" i2="1"><s1>HILL (Heather)</s1>
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<s2>Washington, Maryland</s2>
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<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>The EMMES Corporation</s1>
<s2>Rockville, Maryland</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>University of Iowa Carver College of Medicine and the Iowa City VA Healthcare System</s1>
<s2>Iowa City, Iowa</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Stanford University School of Medicine</s1>
<s2>Stanford, California</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Cincinnati Children's Hospital Medical Center</s1>
<s2>Cincinnati, Ohio</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Emory University School of Medicine</s1>
<s2>Atlanta, Georgia</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Southern Research Institute</s1>
<s2>Birmingham, Alabama</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA20><s1>811-820</s1>
</fA20>
<fA21><s1>2012</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>2052</s2>
<s5>354000509502200040</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2012 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>34 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>12-0371820</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>The Journal of infectious diseases</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002A05C10</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B05</s0>
</fC02>
<fC02 i1="03" i2="X"><s0>002A05F04</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Virus grippal A</s0>
<s2>NW</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Influenza A virus</s0>
<s2>NW</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Influenza A virus</s0>
<s2>NW</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Homme</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Human</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Hombre</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Immunogénicité</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Immunogenicity</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Inmunogenicidad</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Vaccin</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Vaccine</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Vacuna</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Adjuvant immunologique</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Immunological adjuvant</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Coadyuvante inmunológico</s0>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Personne âgée</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Elderly</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Anciano</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Infection</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Infection</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Infección</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Grippe A</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Influenza A</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Gripe A</s0>
<s5>14</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Virose</s0>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Viral disease</s0>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Virosis</s0>
</fC07>
<fN21><s1>289</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 12-0371820 INIST</NO>
<ET>Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons</ET>
<AU>JACKSON (Lisa A.); CHEN (Wilbur H.); STAPLETON (Jack T.); DEKKER (Cornelia L.); WALD (Anna); BRADY (Rebecca C.); EDUPUGANTI (Srilatha); WINOKUR (Patricia); MULLIGAN (Mark J.); KEYSERLING (Harry L.); KOTLOFF (Karen L.); ROUPHAEL (Nadine); NOAH (Diana L.); HILL (Heather); WOLFF (Mark C.)</AU>
<AF>Group Health Research Institute and/Etats-Unis (1 aut.); University of Washington, Seattle/Washington, Maryland/Etats-Unis (5 aut.); Center for Vaccine Development, University of Maryland School of Medicine/Baltimore/Etats-Unis (2 aut., 11 aut.); The EMMES Corporation/Rockville, Maryland/Etats-Unis (14 aut., 15 aut.); University of Iowa Carver College of Medicine and the Iowa City VA Healthcare System/Iowa City, Iowa/Etats-Unis (3 aut., 8 aut.); Stanford University School of Medicine/Stanford, California/Etats-Unis (4 aut.); Cincinnati Children's Hospital Medical Center/Cincinnati, Ohio/Etats-Unis (6 aut.); Emory University School of Medicine/Atlanta, Georgia/Etats-Unis (7 aut., 9 aut., 10 aut., 12 aut.); Southern Research Institute/Birmingham, Alabama/Etats-Unis (13 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>The Journal of infectious diseases; ISSN 0022-1899; Coden JIDIAQ; Royaume-Uni; Da. 2012; Vol. 206; No. 6; Pp. 811-820; Bibl. 34 ref.</SO>
<LA>Anglais</LA>
<EA>Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 μg, 7.5 μg, or 15 μg with AS03 or 7.5 μg or 15 μg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons >65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 μg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 μg adjuvanted group with the 15 μg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated.</EA>
<CC>002A05C10; 002B05; 002A05F04</CC>
<FD>Virus grippal A; Homme; Immunogénicité; Vaccin; Adjuvant immunologique; Personne âgée; Infection; Grippe A</FD>
<FG>Influenzavirus A; Orthomyxoviridae; Virus; Virose</FG>
<ED>Influenza A virus; Human; Immunogenicity; Vaccine; Immunological adjuvant; Elderly; Infection; Influenza A</ED>
<EG>Influenzavirus A; Orthomyxoviridae; Virus; Viral disease</EG>
<SD>Influenza A virus; Hombre; Inmunogenicidad; Vacuna; Coadyuvante inmunológico; Anciano; Infección; Gripe A</SD>
<LO>INIST-2052.354000509502200040</LO>
<ID>12-0371820</ID>
</server>
</inist>
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