Immunogenicity of an inactivated adjuvanted whole‐virion influenza A (H5N1, NIBRG‐14) vaccine administered by intramuscular or subcutaneous injection
Identifieur interne : 001109 ( Istex/Curation ); précédent : 001108; suivant : 001110Immunogenicity of an inactivated adjuvanted whole‐virion influenza A (H5N1, NIBRG‐14) vaccine administered by intramuscular or subcutaneous injection
Auteurs : Daisuke Ikeno ; Kazuhiko Kimachi ; Yoichiro Kino ; Seiichi Harada ; Kayo Yoshida ; Shinji Tochihara ; Shigeyuki Itamura ; Takato Odagiri ; Masato Tashiro ; Kenji Okada ; Chiaki Miyazaki ; Kohji Ueda [Japon]Source :
- Microbiology and Immunology [ 0385-5600 ] ; 2010-02.
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- Teeft :
- Adjuvant, Administration route, Administration routes, Adverse events, Alum, Alum adjuvant, Aluminum hydroxide, Antibody titer, Antibody titers, Blackwell publishing asia, Cell culture, Chmp criteria, Clinical study, Clinical trial, Dos, Erythema, European union chmp criteria, Healthy adults, Healthy japanese, Horse erythrocytes, Immune, Immune response, Immune responses, Immunogenicity, Induration pruritus pyrexia headache malaise chill diarrhea, Infectious diseases, Injection, Kawabe kyokushi, Kikuchi research center, Microbiol immunol, More immunogenic, National institute, Pain erythema, Pandemic, Pruritus, Randomised trial, Research institute, Seasonal vaccines, Second dose, Second doses, Seroconversion, Seroconversion factor, Seroconversion factor seropositivity seroconversion, Serum samples, Statistical analysis, Subcutaneous injection, Titer, Vaccination, Vaccine, Whole virion vaccine.
Abstract
The immunogenicity and safety profile of an inactivated whole‐virion influenza A (H5N1, NIBRG‐14) vaccine with alum adjuvant that was administered by IM or SC injection in a phase I clinical study involving 120 healthy Japanese men aged 20–40 years is described. The serological response of the IM group was stronger than that of the SC group. Local adverse events were less severe with IM injection than with SC injection, while similar systemic adverse events were seen in both groups. These results indicate that, when administering an inactivated whole virion vaccine with alum adjuvant for pandemic influenza, IM injection may achieve better immunogenicity and safety than SC injection.
Url:
DOI: 10.1111/j.1348-0421.2009.00191.x
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Daisuke Ikeno<affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation><affiliation><mods:affiliation>National Institute of Infectious Diseases, Gakuen 4‐7‐1, Musashi‐Murayama, Tokyo 208‐0011</mods:affiliation><wicri:noCountry code="subField">208‐0011</wicri:noCountry></affiliation><affiliation><mods:affiliation>National Institute of Infectious Diseases, Gakuen 4‐7‐1, Musashi‐Murayama, Tokyo 208‐0011</mods:affiliation><wicri:noCountry code="subField">208‐0011</wicri:noCountry></affiliation><affiliation><mods:affiliation>National Institute of Infectious Diseases, Gakuen 4‐7‐1, Musashi‐Murayama, Tokyo 208‐0011</mods:affiliation><wicri:noCountry code="subField">208‐0011</wicri:noCountry></affiliation><affiliation><mods:affiliation>Section of Pediatrics, Fukuoka National Hospital, 4‐39‐1 Yakatabaru, Minami‐ku, Fukuoka, 811‐1394</mods:affiliation><wicri:noCountry code="subField">811‐1394</wicri:noCountry></affiliation><affiliation><mods:affiliation>Fukuoka‐West Rehabilitation Center, Fukuoka, Fukuoka 819‐0005</mods:affiliation><wicri:noCountry code="subField">819‐0005</wicri:noCountry></affiliation>Le document en format XML
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code="subField">811‐1394</wicri:noCountry></affiliation></author><author><name sortKey="Miyazaki, Chiaki" sort="Miyazaki, Chiaki" uniqKey="Miyazaki C" first="Chiaki" last="Miyazaki">Chiaki Miyazaki</name><affiliation><mods:affiliation>Fukuoka‐West Rehabilitation Center, Fukuoka, Fukuoka 819‐0005</mods:affiliation><wicri:noCountry code="subField">819‐0005</wicri:noCountry></affiliation></author><author><name sortKey="Ueda, Kohji" sort="Ueda, Kohji" uniqKey="Ueda K" first="Kohji" last="Ueda">Kohji Ueda</name><affiliation wicri:level="1"><mods:affiliation>Faculty of Health and Welfare, Seinan Jo Gakuin University, 1‐3‐5 Ibori Kokurakitaku, Kitakyusyu 803‐0835, Japan</mods:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>Faculty of Health and Welfare, Seinan Jo Gakuin University, 1‐3‐5 Ibori Kokurakitaku, Kitakyusyu 803‐0835</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno 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code="subField">869‐1298</wicri:noCountry></affiliation></author><author><name sortKey="Kimachi, Kazuhiko" sort="Kimachi, Kazuhiko" uniqKey="Kimachi K" first="Kazuhiko" last="Kimachi">Kazuhiko Kimachi</name><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation></author><author><name sortKey="Kino, Yoichiro" sort="Kino, Yoichiro" uniqKey="Kino Y" first="Yoichiro" last="Kino">Yoichiro Kino</name><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation></author><author><name sortKey="Harada, Seiichi" sort="Harada, Seiichi" uniqKey="Harada S" first="Seiichi" last="Harada">Seiichi Harada</name><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation></author><author><name sortKey="Yoshida, Kayo" sort="Yoshida, Kayo" uniqKey="Yoshida K" first="Kayo" last="Yoshida">Kayo Yoshida</name><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation></author><author><name sortKey="Tochihara, Shinji" sort="Tochihara, Shinji" uniqKey="Tochihara S" first="Shinji" last="Tochihara">Shinji Tochihara</name><affiliation><mods:affiliation>The Chemo‐Sero‐Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869‐1298</mods:affiliation><wicri:noCountry code="subField">869‐1298</wicri:noCountry></affiliation></author><author><name sortKey="Itamura, Shigeyuki" sort="Itamura, Shigeyuki" uniqKey="Itamura S" first="Shigeyuki" last="Itamura">Shigeyuki Itamura</name><affiliation><mods:affiliation>National Institute of Infectious Diseases, Gakuen 4‐7‐1, Musashi‐Murayama, Tokyo 208‐0011</mods:affiliation><wicri:noCountry code="subField">208‐0011</wicri:noCountry></affiliation></author><author><name sortKey="Odagiri, Takato" sort="Odagiri, Takato" uniqKey="Odagiri T" first="Takato" last="Odagiri">Takato Odagiri</name><affiliation><mods:affiliation>National Institute of Infectious Diseases, Gakuen 4‐7‐1, Musashi‐Murayama, Tokyo 208‐0011</mods:affiliation><wicri:noCountry code="subField">208‐0011</wicri:noCountry></affiliation></author><author><name sortKey="Tashiro, Masato" sort="Tashiro, Masato" uniqKey="Tashiro M" first="Masato" last="Tashiro">Masato Tashiro</name><affiliation><mods:affiliation>National Institute of Infectious Diseases, Gakuen 4‐7‐1, Musashi‐Murayama, Tokyo 208‐0011</mods:affiliation><wicri:noCountry code="subField">208‐0011</wicri:noCountry></affiliation></author><author><name sortKey="Okada, Kenji" sort="Okada, Kenji" uniqKey="Okada K" first="Kenji" last="Okada">Kenji Okada</name><affiliation><mods:affiliation>Section of Pediatrics, Fukuoka National Hospital, 4‐39‐1 Yakatabaru, Minami‐ku, Fukuoka, 811‐1394</mods:affiliation><wicri:noCountry code="subField">811‐1394</wicri:noCountry></affiliation></author><author><name sortKey="Miyazaki, Chiaki" sort="Miyazaki, Chiaki" uniqKey="Miyazaki C" first="Chiaki" last="Miyazaki">Chiaki Miyazaki</name><affiliation><mods:affiliation>Fukuoka‐West Rehabilitation Center, Fukuoka, Fukuoka 819‐0005</mods:affiliation><wicri:noCountry code="subField">819‐0005</wicri:noCountry></affiliation></author><author><name sortKey="Ueda, Kohji" sort="Ueda, Kohji" uniqKey="Ueda K" first="Kohji" last="Ueda">Kohji Ueda</name><affiliation wicri:level="1"><mods:affiliation>Faculty of Health and Welfare, Seinan Jo Gakuin University, 1‐3‐5 Ibori Kokurakitaku, Kitakyusyu 803‐0835, Japan</mods:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>Faculty of Health and Welfare, Seinan Jo Gakuin University, 1‐3‐5 Ibori Kokurakitaku, Kitakyusyu 803‐0835</wicri:regionArea></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Microbiology and Immunology</title><title level="j" type="alt">MICROBIOLOGY IMMUNOLOGY</title><idno type="ISSN">0385-5600</idno><idno type="eISSN">1348-0421</idno><imprint><biblScope unit="vol">54</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="81">81</biblScope><biblScope unit="page" to="88">88</biblScope><biblScope unit="page-count">8</biblScope><publisher>Blackwell Publishing Asia</publisher><pubPlace>Melbourne, Australia</pubPlace><date type="published" when="2010-02">2010-02</date></imprint><idno type="ISSN">0385-5600</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0385-5600</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Adjuvant</term><term>Administration route</term><term>Administration routes</term><term>Adverse events</term><term>Alum</term><term>Alum adjuvant</term><term>Aluminum hydroxide</term><term>Antibody titer</term><term>Antibody titers</term><term>Blackwell publishing asia</term><term>Cell culture</term><term>Chmp criteria</term><term>Clinical study</term><term>Clinical trial</term><term>Dos</term><term>Erythema</term><term>European union chmp criteria</term><term>Healthy adults</term><term>Healthy japanese</term><term>Horse erythrocytes</term><term>Immune</term><term>Immune response</term><term>Immune responses</term><term>Immunogenicity</term><term>Induration pruritus pyrexia headache malaise chill diarrhea</term><term>Infectious diseases</term><term>Injection</term><term>Kawabe kyokushi</term><term>Kikuchi research center</term><term>Microbiol immunol</term><term>More immunogenic</term><term>National institute</term><term>Pain erythema</term><term>Pandemic</term><term>Pruritus</term><term>Randomised trial</term><term>Research institute</term><term>Seasonal vaccines</term><term>Second dose</term><term>Second doses</term><term>Seroconversion</term><term>Seroconversion factor</term><term>Seroconversion factor seropositivity seroconversion</term><term>Serum samples</term><term>Statistical analysis</term><term>Subcutaneous injection</term><term>Titer</term><term>Vaccination</term><term>Vaccine</term><term>Whole virion vaccine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The immunogenicity and safety profile of an inactivated whole‐virion influenza A (H5N1, NIBRG‐14) vaccine with alum adjuvant that was administered by IM or SC injection in a phase I clinical study involving 120 healthy Japanese men aged 20–40 years is described. The serological response of the IM group was stronger than that of the SC group. Local adverse events were less severe with IM injection than with SC injection, while similar systemic adverse events were seen in both groups. These results indicate that, when administering an inactivated whole virion vaccine with alum adjuvant for pandemic influenza, IM injection may achieve better immunogenicity and safety than SC injection.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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