Safety and Immunogenicity of Nonadjuvanted and MF59-Adjuvanted Influenza A/H9N2 Vaccine Preparations
Identifieur interne : 001508 ( Main/Exploration ); précédent : 001507; suivant : 001509Safety and Immunogenicity of Nonadjuvanted and MF59-Adjuvanted Influenza A/H9N2 Vaccine Preparations
Auteurs : Robert L. Atmar [États-Unis] ; Wendy A. Keitel [États-Unis] ; Shital M. Patel [États-Unis] ; Jacqueline M. Katz [Géorgie (pays)] ; Dewei She [États-Unis] ; Hana El Sahly [États-Unis] ; Justine Pompey [Géorgie (pays)] ; Thomas R. Cate [États-Unis] ; Robert B. Couch [États-Unis]Source :
- Clinical Infectious Diseases [ 1058-4838 ] ; 2006.
Abstract
Background. Influenza A/H9N2 viruses can infect humans and are considered to be a pandemic threat. Effective vaccines are needed for these and other avian influenza viruses. Methods. We performed a phase I, randomized, double-blind trial to evaluate the safety and immunogenicity of a 2-dose schedule (administered on days 0 and 28) of 4 dose levels (3.75, 7.5, 15, and 30 µg of hemagglutinin) of inactivated influenza A/chicken/Hong Kong/G9/97 (H9N2) vaccine with and without MF59 adjuvant. Vaccine safety was assessed with a diary and selected blood tests. Immunogenicity was measured using serum hemagglutination inhibition (HAI) and microneutralization (MNt) antibody assays. Results. Ninety-six healthy adults (age, 18–34 years) were enrolled in the study. Arm discomfort was more common in groups that received adjuvant, but adverse effects of the vaccination were generally mild. Geometric mean serum HAI and MNt antibody titers to the influenza A/chicken/Hong Kong/G9/97 (H9N2) virus strain for all vaccine groups were similar on day 0 but were significantly higher (P < .001) on both days 28 and 56 for the MF59-adjuvanted vaccine groups than for groups given nonadjuvanted vaccine. Other measures of immunogenicity were also higher in the adjuvanted vaccine groups. HAI and MNt geometric mean titers measured after the administration of a single dose of MF59-adjuvanted vaccine were similar to those measured after 2 doses of nonadjuvanted vaccine. Conclusions. The combination of MF59 adjuvant with a subunit vaccine was associated with improved immune responses to an influenza A/H9N2 virus. The adjuvanted vaccine was immunogenic even after a single dose, raising the possibility that a 1-dose vaccination strategy may be attainable with the use of adjuvanted vaccine.
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DOI: 10.1086/508174
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Atmar</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation><affiliation wicri:level="1"><country wicri:rule="url">États-Unis</country></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Reprints or correspondence: Dr. Robert L. Atmar, 1 Baylor Plaza, MS BCM280, Houston</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"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Molecular Virology and Microbiology, Baylor College of Medicine, Houston</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"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation></author><author><name sortKey="Katz, Jacqueline M" sort="Katz, Jacqueline M" uniqKey="Katz J" first="Jacqueline M." last="Katz">Jacqueline M. Katz</name><affiliation wicri:level="1"><country xml:lang="fr">Géorgie (pays)</country><wicri:regionArea>Departments of Influenza Branch, Centers for Disease Control and Prevention, Atlanta</wicri:regionArea><wicri:noRegion>Atlanta</wicri:noRegion></affiliation></author><author><name sortKey="She, Dewei" sort="She, Dewei" uniqKey="She D" first="Dewei" last="She">Dewei She</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>Departments of EMMES Corporation, Rockville</wicri:cityArea></affiliation></author><author><name sortKey="El Sahly, Hana" sort="El Sahly, Hana" uniqKey="El Sahly H" first="Hana" last="El Sahly">Hana El Sahly</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation></author><author><name sortKey="Pompey, Justine" sort="Pompey, Justine" uniqKey="Pompey J" first="Justine" last="Pompey">Justine Pompey</name><affiliation wicri:level="1"><country xml:lang="fr">Géorgie (pays)</country><wicri:regionArea>Departments of Influenza Branch, Centers for Disease Control and Prevention, Atlanta</wicri:regionArea><wicri:noRegion>Atlanta</wicri:noRegion></affiliation></author><author><name sortKey="Cate, Thomas R" sort="Cate, Thomas R" uniqKey="Cate T" first="Thomas R." last="Cate">Thomas R. Cate</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation></author><author><name sortKey="Couch, Robert B" sort="Couch, Robert B" uniqKey="Couch R" first="Robert B." last="Couch">Robert B. Couch</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Departments of Molecular Virology and Microbiology, Baylor College of Medicine, Houston</wicri:cityArea></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Clinical Infectious Diseases</title><title level="j" type="abbrev">Clinical Infectious Diseases</title><idno type="ISSN">1058-4838</idno><idno type="eISSN">1537-6591</idno><imprint><publisher>The University of Chicago Press</publisher><date when="2006-11-01">2006</date><biblScope unit="vol">43</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="1135">1135</biblScope><biblScope unit="page" to="1142">1142</biblScope></imprint><idno type="ISSN">1058-4838</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1058-4838</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background. Influenza A/H9N2 viruses can infect humans and are considered to be a pandemic threat. Effective vaccines are needed for these and other avian influenza viruses. Methods. We performed a phase I, randomized, double-blind trial to evaluate the safety and immunogenicity of a 2-dose schedule (administered on days 0 and 28) of 4 dose levels (3.75, 7.5, 15, and 30 µg of hemagglutinin) of inactivated influenza A/chicken/Hong Kong/G9/97 (H9N2) vaccine with and without MF59 adjuvant. Vaccine safety was assessed with a diary and selected blood tests. Immunogenicity was measured using serum hemagglutination inhibition (HAI) and microneutralization (MNt) antibody assays. Results. Ninety-six healthy adults (age, 18–34 years) were enrolled in the study. Arm discomfort was more common in groups that received adjuvant, but adverse effects of the vaccination were generally mild. Geometric mean serum HAI and MNt antibody titers to the influenza A/chicken/Hong Kong/G9/97 (H9N2) virus strain for all vaccine groups were similar on day 0 but were significantly higher (P < .001) on both days 28 and 56 for the MF59-adjuvanted vaccine groups than for groups given nonadjuvanted vaccine. Other measures of immunogenicity were also higher in the adjuvanted vaccine groups. HAI and MNt geometric mean titers measured after the administration of a single dose of MF59-adjuvanted vaccine were similar to those measured after 2 doses of nonadjuvanted vaccine. Conclusions. The combination of MF59 adjuvant with a subunit vaccine was associated with improved immune responses to an influenza A/H9N2 virus. The adjuvanted vaccine was immunogenic even after a single dose, raising the possibility that a 1-dose vaccination strategy may be attainable with the use of adjuvanted vaccine.</div></front></TEI><affiliations><list><country><li>Géorgie (pays)</li><li>États-Unis</li></country><region><li>Maryland</li><li>Texas</li></region></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Atmar, Robert L" sort="Atmar, Robert L" uniqKey="Atmar R" first="Robert L." last="Atmar">Robert L. Atmar</name></region><name sortKey="Atmar, Robert L" sort="Atmar, Robert L" uniqKey="Atmar R" first="Robert L." last="Atmar">Robert L. Atmar</name><name sortKey="Atmar, Robert L" sort="Atmar, Robert L" uniqKey="Atmar R" first="Robert L." last="Atmar">Robert L. Atmar</name><name sortKey="Atmar, Robert L" sort="Atmar, Robert L" uniqKey="Atmar R" first="Robert L." last="Atmar">Robert L. Atmar</name><name sortKey="Cate, Thomas R" sort="Cate, Thomas R" uniqKey="Cate T" first="Thomas R." last="Cate">Thomas R. Cate</name><name sortKey="Cate, Thomas R" sort="Cate, Thomas R" uniqKey="Cate T" first="Thomas R." last="Cate">Thomas R. Cate</name><name sortKey="Couch, Robert B" sort="Couch, Robert B" uniqKey="Couch R" first="Robert B." last="Couch">Robert B. Couch</name><name sortKey="Couch, Robert B" sort="Couch, Robert B" uniqKey="Couch R" first="Robert B." last="Couch">Robert B. Couch</name><name sortKey="El Sahly, Hana" sort="El Sahly, Hana" uniqKey="El Sahly H" first="Hana" last="El Sahly">Hana El Sahly</name><name sortKey="El Sahly, Hana" sort="El Sahly, Hana" uniqKey="El Sahly H" first="Hana" last="El Sahly">Hana El Sahly</name><name sortKey="Keitel, Wendy A" sort="Keitel, Wendy A" uniqKey="Keitel W" first="Wendy A." last="Keitel">Wendy A. Keitel</name><name sortKey="Keitel, Wendy A" sort="Keitel, Wendy A" uniqKey="Keitel W" first="Wendy A." last="Keitel">Wendy A. Keitel</name><name sortKey="Patel, Shital M" sort="Patel, Shital M" uniqKey="Patel S" first="Shital M." last="Patel">Shital M. Patel</name><name sortKey="Patel, Shital M" sort="Patel, Shital M" uniqKey="Patel S" first="Shital M." last="Patel">Shital M. Patel</name><name sortKey="She, Dewei" sort="She, Dewei" uniqKey="She D" first="Dewei" last="She">Dewei She</name></country><country name="Géorgie (pays)"><noRegion><name sortKey="Katz, Jacqueline M" sort="Katz, Jacqueline M" uniqKey="Katz J" first="Jacqueline M." last="Katz">Jacqueline M. Katz</name></noRegion><name sortKey="Pompey, Justine" sort="Pompey, Justine" uniqKey="Pompey J" first="Justine" last="Pompey">Justine Pompey</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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