PandemieGrippaleV1, PascalFrancis, Curation, bibRecord, 001913

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 : 001913 ( PascalFrancis/Curation ); précédent : 001912; suivant : 001914

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

Auteurs : Lisa A. Jackson [États-Unis] ; Wilbur H. Chen [États-Unis] ; Jack T. Stapleton [États-Unis] ; Cornelia L. Dekker [États-Unis] ; Anna Wald [États-Unis] ; Rebecca C. Brady [États-Unis] ; Srilatha Edupuganti [États-Unis] ; Patricia Winokur [États-Unis] ; Mark J. Mulligan [États-Unis] ; Harry L. Keyserling [États-Unis] ; Karen L. Kotloff [États-Unis] ; Nadine Rouphael [États-Unis] ; Diana L. Noah [États-Unis] ; Heather Hill [États-Unis] ; Mark C. Wolff [États-Unis]

Source :

The Journal of infectious diseases [ 0022-1899 ] ; 2012.

RBID : Pascal:12-0371820

Descripteurs français

Pascal (Inist)
- Virus grippal A, Homme, Immunogénicité, Vaccin, Adjuvant immunologique, Personne âgée, Infection, Grippe A.
Wicri :
- topic : Homme, Vaccin, Personne âgée.

English descriptors

KwdEn :
- Elderly, Human, Immunogenicity, Immunological adjuvant, Infection, Influenza A, Influenza A virus, Vaccine.

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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A08	`01`	`1`	`ENG`	`@1 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`
A11	`01`	`1`		`@1 JACKSON (Lisa A.)`
A11	`02`	`1`		`@1 CHEN (Wilbur H.)`
A11	`03`	`1`		`@1 STAPLETON (Jack T.)`
A11	`04`	`1`		`@1 DEKKER (Cornelia L.)`
A11	`05`	`1`		`@1 WALD (Anna)`
A11	`06`	`1`		`@1 BRADY (Rebecca C.)`
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A11	`08`	`1`		`@1 WINOKUR (Patricia)`
A11	`09`	`1`		`@1 MULLIGAN (Mark J.)`
A11	`10`	`1`		`@1 KEYSERLING (Harry L.)`
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A11	`13`	`1`		`@1 NOAH (Diana L.)`
A11	`14`	`1`		`@1 HILL (Heather)`
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C01	`01`		`ENG`	@0 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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Pascal:12-0371820

Le document en format XML

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<author><name sortKey="Brady, Rebecca C" sort="Brady, Rebecca C" uniqKey="Brady R" first="Rebecca C." last="Brady">Rebecca C. Brady</name>
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<author><name sortKey="Edupuganti, Srilatha" sort="Edupuganti, Srilatha" uniqKey="Edupuganti S" first="Srilatha" last="Edupuganti">Srilatha Edupuganti</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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<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>
<author><name sortKey="Jackson, Lisa A" sort="Jackson, Lisa A" uniqKey="Jackson L" first="Lisa A." last="Jackson">Lisa A. Jackson</name>
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<author><name sortKey="Chen, Wilbur H" sort="Chen, Wilbur H" uniqKey="Chen W" first="Wilbur H." last="Chen">Wilbur H. Chen</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Center for Vaccine Development, University of Maryland School of Medicine</s1>
<s2>Baltimore</s2>
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</inist:fA14>
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<author><name sortKey="Stapleton, Jack T" sort="Stapleton, Jack T" uniqKey="Stapleton J" first="Jack T." last="Stapleton">Jack T. Stapleton</name>
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<s2>Iowa City, Iowa</s2>
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<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Dekker, Cornelia L" sort="Dekker, Cornelia L" uniqKey="Dekker C" first="Cornelia L." last="Dekker">Cornelia L. Dekker</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Stanford University School of Medicine</s1>
<s2>Stanford, California</s2>
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<country>États-Unis</country>
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</author>
<author><name sortKey="Wald, Anna" sort="Wald, Anna" uniqKey="Wald A" first="Anna" last="Wald">Anna Wald</name>
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<s2>Washington, Maryland</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
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</author>
<author><name sortKey="Brady, Rebecca C" sort="Brady, Rebecca C" uniqKey="Brady R" first="Rebecca C." last="Brady">Rebecca C. Brady</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Cincinnati Children's Hospital Medical Center</s1>
<s2>Cincinnati, Ohio</s2>
<s3>USA</s3>
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</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Edupuganti, Srilatha" sort="Edupuganti, Srilatha" uniqKey="Edupuganti S" first="Srilatha" last="Edupuganti">Srilatha Edupuganti</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Emory University School of Medicine</s1>
<s2>Atlanta, Georgia</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
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<sZ>10 aut.</sZ>
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</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Winokur, Patricia" sort="Winokur, Patricia" uniqKey="Winokur P" first="Patricia" last="Winokur">Patricia Winokur</name>
<affiliation wicri:level="1"><inist: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>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Mulligan, Mark J" sort="Mulligan, Mark J" uniqKey="Mulligan M" first="Mark J." last="Mulligan">Mark J. Mulligan</name>
<affiliation wicri:level="1"><inist: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>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Keyserling, Harry L" sort="Keyserling, Harry L" uniqKey="Keyserling H" first="Harry L." last="Keyserling">Harry L. Keyserling</name>
<affiliation wicri:level="1"><inist: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>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Kotloff, Karen L" sort="Kotloff, Karen L" uniqKey="Kotloff K" first="Karen L." last="Kotloff">Karen L. Kotloff</name>
<affiliation wicri:level="1"><inist: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>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Rouphael, Nadine" sort="Rouphael, Nadine" uniqKey="Rouphael N" first="Nadine" last="Rouphael">Nadine Rouphael</name>
<affiliation wicri:level="1"><inist: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>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Southern Research Institute</s1>
<s2>Birmingham, Alabama</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>The EMMES Corporation</s1>
<s2>Rockville, Maryland</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Wolff, Mark C" sort="Wolff, Mark C" uniqKey="Wolff M" first="Mark C." last="Wolff">Mark C. Wolff</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>The EMMES Corporation</s1>
<s2>Rockville, Maryland</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">The Journal of infectious diseases</title>
<title level="j" type="abbreviated">J. infect. dis.</title>
<idno type="ISSN">0022-1899</idno>
<imprint><date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">The Journal of infectious diseases</title>
<title level="j" type="abbreviated">J. infect. dis.</title>
<idno type="ISSN">0022-1899</idno>
</seriesStmt>
</fileDesc>
<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>
<term>Infection</term>
<term>Grippe A</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
<term>Vaccin</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>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0022-1899</s0>
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<fA02 i1="01"><s0>JIDIAQ</s0>
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<fA03 i2="1"><s0>J. infect. dis.</s0>
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<fA08 i1="01" i2="1" l="ENG"><s1>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</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>JACKSON (Lisa A.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>CHEN (Wilbur H.)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>STAPLETON (Jack T.)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>DEKKER (Cornelia L.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>WALD (Anna)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>BRADY (Rebecca C.)</s1>
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<fA11 i1="07" i2="1"><s1>EDUPUGANTI (Srilatha)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>WINOKUR (Patricia)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>MULLIGAN (Mark J.)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>KEYSERLING (Harry L.)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>KOTLOFF (Karen L.)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>ROUPHAEL (Nadine)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>NOAH (Diana L.)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>HILL (Heather)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>WOLFF (Mark C.)</s1>
</fA11>
<fA14 i1="01"><s1>Group Health Research Institute and</s1>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>University of Washington, Seattle</s1>
<s2>Washington, Maryland</s2>
<s3>USA</s3>
<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>
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<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>
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<fA64 i1="01" i2="1"><s0>The Journal of infectious diseases</s0>
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</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>
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<s5>01</s5>
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<s5>01</s5>
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<s2>NW</s2>
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<s2>NW</s2>
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<fC07 i1="03" i2="X" l="SPA"><s0>Virus</s0>
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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

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

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