Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant
Identifieur interne : 000D98 ( Main/Merge ); précédent : 000D97; suivant : 000D99Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant
Auteurs : Wilbur H. Chen ; Lisa A. Jackson [États-Unis] ; Kathryn M. Edwards [États-Unis] ; Wendy A. Keitel [États-Unis] ; Heather Hill [États-Unis] ; Diana L. Noah [États-Unis] ; C. Buddy Creech [États-Unis] ; Shital M. Patel [États-Unis] ; Brian Mangal [États-Unis] ; Karen L. KotloffSource :
- Open Forum Infectious Diseases [ 2328-8957 ] ; 2014.
Abstract
The national stockpile for influenza pandemic preparedness includes vaccines against an array of strains and adjuvants that could be utilized to induce immunologic priming as a pandemic wave emerges. We assessed the feasibility of a strategy that allows the flexibility of postmanufacture mixture of vaccine and adjuvant at the point of care.
We conducted a randomized, double-blind, multicenter trial among healthy adults aged 18–49 years who received 2 doses of inactivated influenza A/Indonesia/05/2005 (H5N1 clade 2.2.3) virus vaccine containing either 3.75, 7.5, or 15 µg of hemagglutinin (HA) with or without AS03 adjuvant, administered 21 days apart. Subjects were observed for local (injection site) and systemic reactogenicity and adverse events. Sera were tested for hemagglutination inhibition (HAI) and microneutralization (MN) antibody levels against the homologous strain and 4 heterologous avian strains.
Vaccine containing ASO3 adjuvant was associated with significantly more local reactions compared with nonadjuvanted vaccine, but these were short-lived and resolved spontaneously. Although the immune response to nonadjuvanted vaccine was poor, 2 doses of AS03-adjuvanted vaccine containing as little as 3.75 µg of HA elicited robust immune responses resulting in seroprotective titers (≥1:40) to the homologous strain in ≥86% of subjects by HAI and in 95% of subjects by MN. Cross-clade antibody responses were also observed with AS03-adjuvanted vaccine, but not nonadjuvanted vaccine.
AS03 adjuvant formulated with inactivated vaccine at the administration site significantly enhanced the immune responses to H5N1 vaccine and has the potential to markedly improve vaccine responses and accelerate delivery during an influenza pandemic.
NCT01317758.
Url:
DOI: 10.1093/ofid/ofu091
PubMed: 25734159
PubMed Central: 4324222
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Chen</name><affiliation><nlm:aff id="af1"><addr-line>Center for Vaccine Development</addr-line>,<institution>University of Maryland School of Medicine</institution>,<addr-line>Baltimore</addr-line></nlm:aff></affiliation></author><author><name sortKey="Jackson, Lisa A" sort="Jackson, Lisa A" uniqKey="Jackson L" first="Lisa A." last="Jackson">Lisa A. Jackson</name><affiliation wicri:level="2"><nlm:aff id="af2"><institution>Group Health Research Institute</institution>,<addr-line>Seattle, Washington</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Washington (État)</region></placeName><wicri:cityArea>Seattle</wicri:cityArea></affiliation></author><author><name sortKey="Edwards, Kathryn M" sort="Edwards, Kathryn M" uniqKey="Edwards K" first="Kathryn M." last="Edwards">Kathryn M. Edwards</name><affiliation wicri:level="2"><nlm:aff id="af3"><addr-line>Vanderbilt Vaccine Research Program</addr-line>,<institution>Vanderbilt University School of Medicine</institution>,<addr-line>Nashville, Tennessee</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Nashville</wicri:cityArea></affiliation></author><author><name sortKey="Keitel, Wendy A" sort="Keitel, Wendy A" uniqKey="Keitel W" first="Wendy A." last="Keitel">Wendy A. Keitel</name><affiliation wicri:level="2"><nlm:aff id="af4"><institution>Baylor College of Medicine</institution>,<addr-line>Houston, Texas</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Houston</wicri:cityArea></affiliation></author><author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><affiliation wicri:level="2"><nlm:aff id="af5"><institution>EMMES Corporation</institution>,<addr-line>Rockville, Maryland</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>Rockville</wicri:cityArea></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="2"><nlm:aff id="af6"><institution>Southern Research</institution>,<addr-line>Birmingham, Alabama</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Alabama</region></placeName><wicri:cityArea>Birmingham</wicri:cityArea></affiliation></author><author><name sortKey="Creech, C Buddy" sort="Creech, C Buddy" uniqKey="Creech C" first="C. Buddy" last="Creech">C. Buddy Creech</name><affiliation wicri:level="2"><nlm:aff id="af3"><addr-line>Vanderbilt Vaccine Research Program</addr-line>,<institution>Vanderbilt University School of Medicine</institution>,<addr-line>Nashville, Tennessee</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Nashville</wicri:cityArea></affiliation></author><author><name sortKey="Patel, Shital M" sort="Patel, Shital M" uniqKey="Patel S" first="Shital M." last="Patel">Shital M. Patel</name><affiliation wicri:level="2"><nlm:aff id="af4"><institution>Baylor College of Medicine</institution>,<addr-line>Houston, Texas</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Houston</wicri:cityArea></affiliation></author><author><name sortKey="Mangal, Brian" sort="Mangal, Brian" uniqKey="Mangal B" first="Brian" last="Mangal">Brian Mangal</name><affiliation wicri:level="2"><nlm:aff id="af5"><institution>EMMES Corporation</institution>,<addr-line>Rockville, Maryland</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>Rockville</wicri:cityArea></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><nlm:aff id="af1"><addr-line>Center for Vaccine Development</addr-line>,<institution>University of Maryland School of Medicine</institution>,<addr-line>Baltimore</addr-line></nlm:aff></affiliation></author></analytic><series><title level="j">Open Forum Infectious Diseases</title><idno type="eISSN">2328-8957</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p> The national stockpile for influenza pandemic preparedness includes vaccines against an array of strains and adjuvants that could be utilized to induce immunologic priming as a pandemic wave emerges. We assessed the feasibility of a strategy that allows the flexibility of postmanufacture mixture of vaccine and adjuvant at the point of care.</p></sec><sec><title>Methods</title><p> We conducted a randomized, double-blind, multicenter trial among healthy adults aged 18–49 years who received 2 doses of inactivated influenza A/Indonesia/05/2005 (H5N1 clade 2.2.3) virus vaccine containing either 3.75, 7.5, or 15 µg of hemagglutinin (HA) with or without AS03 adjuvant, administered 21 days apart. Subjects were observed for local (injection site) and systemic reactogenicity and adverse events. Sera were tested for hemagglutination inhibition (HAI) and microneutralization (MN) antibody levels against the homologous strain and 4 heterologous avian strains.</p></sec><sec><title>Results</title><p> Vaccine containing ASO3 adjuvant was associated with significantly more local reactions compared with nonadjuvanted vaccine, but these were short-lived and resolved spontaneously. Although the immune response to nonadjuvanted vaccine was poor, 2 doses of AS03-adjuvanted vaccine containing as little as 3.75 µg of HA elicited robust immune responses resulting in seroprotective titers (≥1:40) to the homologous strain in ≥86% of subjects by HAI and in 95% of subjects by MN. Cross-clade antibody responses were also observed with AS03-adjuvanted vaccine, but not nonadjuvanted vaccine.</p></sec><sec><title>Conclusions</title><p> AS03 adjuvant formulated with inactivated vaccine at the administration site significantly enhanced the immune responses to H5N1 vaccine and has the potential to markedly improve vaccine responses and accelerate delivery during an influenza pandemic.</p></sec><sec><title>Clinical Trials Registration</title><p> NCT01317758.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Jennings, Lc" uniqKey="Jennings L">LC Jennings</name></author><author><name sortKey="Monto, As" uniqKey="Monto A">AS Monto</name></author><author><name sortKey="Chan, Pk" uniqKey="Chan P">PK Chan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Belshe, Rb" uniqKey="Belshe R">RB Belshe</name></author><author><name sortKey="Frey, Se" uniqKey="Frey S">SE Frey</name></author><author><name sortKey="Graham, I" uniqKey="Graham I">I Graham</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Treanor, Jj" uniqKey="Treanor J">JJ Treanor</name></author><author><name sortKey="Campbell, Jd" uniqKey="Campbell J">JD Campbell</name></author><author><name sortKey="Zangwill, Km" uniqKey="Zangwill K">KM Zangwill</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Treanor, Jj" uniqKey="Treanor J">JJ Treanor</name></author><author><name sortKey="Wilkinson, Be" uniqKey="Wilkinson B">BE Wilkinson</name></author><author><name sortKey="Masseoud, F" uniqKey="Masseoud F">F Masseoud</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Noah, Dl" uniqKey="Noah D">DL Noah</name></author><author><name sortKey="Hill, H" uniqKey="Hill H">H Hill</name></author><author><name sortKey="Hines, D" uniqKey="Hines D">D Hines</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chen, Wh" uniqKey="Chen W">WH Chen</name></author><author><name sortKey="Winokur, Pl" uniqKey="Winokur P">PL Winokur</name></author><author><name sortKey="Edwards, Km" uniqKey="Edwards K">KM Edwards</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Atmar, Rl" uniqKey="Atmar R">RL Atmar</name></author><author><name sortKey="Keitel, Wa" uniqKey="Keitel W">WA Keitel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bresson, Jl" uniqKey="Bresson J">JL Bresson</name></author><author><name sortKey="Perronne, C" uniqKey="Perronne C">C Perronne</name></author><author><name sortKey="Launay, O" uniqKey="Launay O">O Launay</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Keitel, Wa" uniqKey="Keitel W">WA Keitel</name></author><author><name sortKey="Campbell, Jd" uniqKey="Campbell J">JD Campbell</name></author><author><name sortKey="Treanor, Jj" uniqKey="Treanor J">JJ Treanor</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Leroux Roels, I" uniqKey="Leroux Roels I">I Leroux-Roels</name></author><author><name sortKey="Borkowski, A" uniqKey="Borkowski A">A Borkowski</name></author><author><name sortKey="Vanwolleghem, T" uniqKey="Vanwolleghem T">T Vanwolleghem</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Langley, Jm" uniqKey="Langley J">JM Langley</name></author><author><name sortKey="Frenette, L" uniqKey="Frenette L">L Frenette</name></author><author><name sortKey="Ferguson, L" uniqKey="Ferguson L">L Ferguson</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Dekker, Cl" uniqKey="Dekker C">CL Dekker</name></author><author><name sortKey="Gordon, L" uniqKey="Gordon L">L Gordon</name></author><author><name sortKey="Klein, J" uniqKey="Klein J">J; Klein</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ferguson, Nm" uniqKey="Ferguson N">NM Ferguson</name></author><author><name sortKey="Cummings, Da" uniqKey="Cummings D">DA Cummings</name></author><author><name sortKey="Fraser, C" uniqKey="Fraser C">C Fraser</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Schwarz, Tf" uniqKey="Schwarz T">TF Schwarz</name></author><author><name sortKey="Horacek, T" uniqKey="Horacek T">T Horacek</name></author><author><name sortKey="Knuf, M" uniqKey="Knuf M">M Knuf</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gilca, V" uniqKey="Gilca V">V Gilca</name></author><author><name sortKey="De Serres, G" uniqKey="De Serres G">G De Serres</name></author><author><name sortKey="Hamelin, Me" uniqKey="Hamelin M">ME Hamelin</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sridhar, S" uniqKey="Sridhar S">S Sridhar</name></author><author><name sortKey="Begom, S" uniqKey="Begom S">S Begom</name></author><author><name sortKey="Bermingham, A" uniqKey="Bermingham A">A Bermingham</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Langley, Jm" uniqKey="Langley J">JM Langley</name></author><author><name sortKey="Risi, G" uniqKey="Risi G">G Risi</name></author><author><name sortKey="Caldwell, M" uniqKey="Caldwell M">M Caldwell</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lasko, B" uniqKey="Lasko B">B Lasko</name></author><author><name sortKey="Reich, D" uniqKey="Reich D">D Reich</name></author><author><name sortKey="Madan, A" uniqKey="Madan A">A Madan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Yang, Pc" uniqKey="Yang P">PC Yang</name></author><author><name sortKey="Yu, Cj" uniqKey="Yu C">CJ Yu</name></author><author><name sortKey="Chang, Sc" uniqKey="Chang S">SC Chang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rowe, T" uniqKey="Rowe T">T Rowe</name></author><author><name sortKey="Abernathy, Ra" uniqKey="Abernathy R">RA Abernathy</name></author><author><name sortKey="Hu Primmer, J" uniqKey="Hu Primmer J">J Hu-Primmer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Baylor, Nw" uniqKey="Baylor N">NW Baylor</name></author><author><name sortKey="Houn, F" uniqKey="Houn F">F Houn</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="De La Herran Arita, Ak" uniqKey="De La Herran Arita A">AK De la Herran-Arita</name></author><author><name sortKey="Kornum, Br" uniqKey="Kornum B">BR Kornum</name></author><author><name sortKey="Mahlios, J" uniqKey="Mahlios J">J Mahlios</name></author></analytic></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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