Immunogenicity, Safety, and Cross-Reactivity of an Inactivated, Adjuvanted, Prototype Pandemic Influenza (H5N1) Vaccine: A Phase II, Double-Blind, Randomized Trial
Identifieur interne : 001193 ( Istex/Curation ); précédent : 001192; suivant : 001194Immunogenicity, Safety, and Cross-Reactivity of an Inactivated, Adjuvanted, Prototype Pandemic Influenza (H5N1) Vaccine: A Phase II, Double-Blind, Randomized Trial
Auteurs : Jiang Wu [République populaire de Chine] ; Han-Hua Fang [République populaire de Chine] ; Jiang-Ting Chen [République populaire de Chine] ; Ji-Chen Zhou [République populaire de Chine] ; Zi-Jian Feng [République populaire de Chine] ; Chang-Gui Li [République populaire de Chine] ; Yuan-Zheng Qiu [République populaire de Chine] ; Yan Liu [République populaire de Chine] ; Min Lu [République populaire de Chine] ; Li-Ying Liu [République populaire de Chine] ; Shan-Shan Dong [République populaire de Chine] ; Qiang Gao [République populaire de Chine] ; Xiao-Mei Zhang [République populaire de Chine] ; Nan Wang [République populaire de Chine] ; Wei-Dong Yin [République populaire de Chine] ; Xiao-Ping Dong [République populaire de Chine]Source :
- Clinical Infectious Diseases [ 1058-4838 ] ; 2009.
Abstract
Background. Avian influenza A virus H5N1 has the potential to cause a pandemic. Adjuvants and whole-virion vaccines are regarded as antigen sparing for pandemic vaccines. Methods. A double-blind, randomized trial was performed from 28 August to 22 December 2007 in 402 adults; 301 adults were randomly assigned to receive 2 doses of an inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine containing 5, 10, or 15 μg of hemagglutinin per dose 28 days apart, and 101 of them received 2 doses of 10 μg of vaccine 14 days apart. The vaccine was manufactured from the recombinant A/Vietman/1194/2004 (NIBRG14) strain. Blood samples were collected for hemagglutination inhibition and microneutralization assays. Results. All formulations were well tolerated, with no serious adverse events. Most local and systemic reactions were mild or moderate. Immune responses were induced after 1 dose in all vaccination groups. The highest immune response was seen after 2 doses of 15 μg of vaccine, with 90% and 100% seroconversion rates and 90% and 100% of participants having a titer of ⩾1:40 for hemagglutination inhibition and microneutralization assays, respectively. Both the 10- and 15-μg doses met or exceeded European Union licensure criteria. Generally, higher immune responses were elicited in participants vaccinated 28 days apart than those vaccinated 14 days apart. Cross-reaction assays showed that after 2 doses of 10 μg of vaccine, 98% and 87% of participants had a microneutralization titer of ⩾1:40 against heterologous Indonesia and Anhui strains, respectively. Conclusions. The inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine not only showed good immunogenicity and safety but also elicited significant cross-reactivity against heterologous H5N1 strains in clade 2. Trial registration. ClinicalTrials.gov identifier: NCT00535665.
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DOI: 10.1086/597401
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Pharmaceuticals and Biological Products, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>National Institute for the Control of Pharmaceuticals and Biological Products, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Chen, Jiang Ting" sort="Chen, Jiang Ting" uniqKey="Chen J" first="Jiang-Ting" last="Chen">Jiang-Ting Chen</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Zhou, Ji Chen" sort="Zhou, Ji Chen" uniqKey="Zhou J" first="Ji-Chen" last="Zhou">Ji-Chen Zhou</name><affiliation wicri:level="1"><mods:affiliation>Huairou Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Huairou Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Feng, Zi Jian" sort="Feng, Zi Jian" uniqKey="Feng Z" first="Zi-Jian" last="Feng">Zi-Jian Feng</name><affiliation wicri:level="1"><mods:affiliation>Chinese Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Chinese Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Li, Chang Gui" sort="Li, Chang Gui" uniqKey="Li C" first="Chang-Gui" last="Li">Chang-Gui Li</name><affiliation wicri:level="1"><mods:affiliation>National Institute for the Control of Pharmaceuticals and Biological Products, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>National Institute for the Control of Pharmaceuticals and Biological Products, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Qiu, Yuan Zheng" sort="Qiu, Yuan Zheng" uniqKey="Qiu Y" first="Yuan-Zheng" last="Qiu">Yuan-Zheng Qiu</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Liu, Yan" sort="Liu, Yan" uniqKey="Liu Y" first="Yan" last="Liu">Yan Liu</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Lu, Min" sort="Lu, Min" uniqKey="Lu M" first="Min" last="Lu">Min Lu</name><affiliation wicri:level="1"><mods:affiliation>Beijing Centers for Diseases Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Beijing Centers for Diseases Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Liu, Li Ying" sort="Liu, Li Ying" uniqKey="Liu L" first="Li-Ying" last="Liu">Li-Ying Liu</name><affiliation wicri:level="1"><mods:affiliation>Huairou Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Huairou Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Dong, Shan Shan" sort="Dong, Shan Shan" uniqKey="Dong S" first="Shan-Shan" last="Dong">Shan-Shan Dong</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Gao, Qiang" sort="Gao, Qiang" uniqKey="Gao Q" first="Qiang" last="Gao">Qiang Gao</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Zhang, Xiao Mei" sort="Zhang, Xiao Mei" uniqKey="Zhang X" first="Xiao-Mei" last="Zhang">Xiao-Mei Zhang</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Wang, Nan" sort="Wang, Nan" uniqKey="Wang N" first="Nan" last="Wang">Nan Wang</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Yin, Wei Dong" sort="Yin, Wei Dong" uniqKey="Yin W" first="Wei-Dong" last="Yin">Wei-Dong Yin</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Dong, Xiao Ping" sort="Dong, Xiao Ping" uniqKey="Dong X" first="Xiao-Ping" last="Dong">Xiao-Ping Dong</name><affiliation wicri:level="1"><mods:affiliation>State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation><affiliation><mods:affiliation>E-mail: dongxp238@sina.com</mods:affiliation><wicri:noCountry code="no comma">E-mail: dongxp238@sina.com</wicri:noCountry></affiliation><affiliation><mods:affiliation>Reprints or correspondence: Dr. Xiao-Ping Dong, Ying-Xin Rd. 100, Beijing (100052), People' Republic of China (dongxp238@sina.com); or Dr. Wei-Dong Yin, No.39 Shangdi Western Road, Haidian District, Beijing (100085), People's Republic of China (yinweidong@sinovac.com).</mods:affiliation><wicri:noCountry code="subField">(yinweidong@sinovac.com).</wicri:noCountry></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:C00DDADFC0C8A4B0099F09C0DD5EA3905DC3EE69</idno><date when="2009" year="2009">2009</date><idno type="doi">10.1086/597401</idno><idno type="url">https://api.istex.fr/ark:/67375/HXZ-JNQZZK01-5/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">001193</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001193</idno><idno type="wicri:Area/Istex/Curation">001193</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Immunogenicity, Safety, and Cross-Reactivity of an Inactivated, Adjuvanted, Prototype Pandemic Influenza (H5N1) Vaccine: A Phase II, Double-Blind, Randomized Trial</title><author><name sortKey="Wu, Jiang" sort="Wu, Jiang" uniqKey="Wu J" first="Jiang" last="Wu">Jiang Wu</name><affiliation wicri:level="1"><mods:affiliation>Beijing Centers for Diseases Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Beijing Centers for Diseases Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Fang, Han Hua" sort="Fang, Han Hua" uniqKey="Fang H" first="Han-Hua" last="Fang">Han-Hua Fang</name><affiliation wicri:level="1"><mods:affiliation>National Institute for the Control of Pharmaceuticals and Biological Products, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>National Institute for the Control of Pharmaceuticals and Biological Products, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Chen, Jiang Ting" sort="Chen, Jiang Ting" uniqKey="Chen J" first="Jiang-Ting" last="Chen">Jiang-Ting Chen</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Zhou, Ji Chen" sort="Zhou, Ji Chen" uniqKey="Zhou J" first="Ji-Chen" last="Zhou">Ji-Chen Zhou</name><affiliation wicri:level="1"><mods:affiliation>Huairou Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Huairou Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Feng, Zi Jian" sort="Feng, Zi Jian" uniqKey="Feng Z" first="Zi-Jian" last="Feng">Zi-Jian Feng</name><affiliation wicri:level="1"><mods:affiliation>Chinese Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Chinese Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Li, Chang Gui" sort="Li, Chang Gui" uniqKey="Li C" first="Chang-Gui" last="Li">Chang-Gui Li</name><affiliation wicri:level="1"><mods:affiliation>National Institute for the Control of Pharmaceuticals and Biological Products, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>National Institute for the Control of Pharmaceuticals and Biological Products, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Qiu, Yuan Zheng" sort="Qiu, Yuan Zheng" uniqKey="Qiu Y" first="Yuan-Zheng" last="Qiu">Yuan-Zheng Qiu</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Liu, Yan" sort="Liu, Yan" uniqKey="Liu Y" first="Yan" last="Liu">Yan Liu</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Lu, Min" sort="Lu, Min" uniqKey="Lu M" first="Min" last="Lu">Min Lu</name><affiliation wicri:level="1"><mods:affiliation>Beijing Centers for Diseases Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Beijing Centers for Diseases Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Liu, Li Ying" sort="Liu, Li Ying" uniqKey="Liu L" first="Li-Ying" last="Liu">Li-Ying Liu</name><affiliation wicri:level="1"><mods:affiliation>Huairou Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Huairou Center for Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Dong, Shan Shan" sort="Dong, Shan Shan" uniqKey="Dong S" first="Shan-Shan" last="Dong">Shan-Shan Dong</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Gao, Qiang" sort="Gao, Qiang" uniqKey="Gao Q" first="Qiang" last="Gao">Qiang Gao</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Zhang, Xiao Mei" sort="Zhang, Xiao Mei" uniqKey="Zhang X" first="Xiao-Mei" last="Zhang">Xiao-Mei Zhang</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Wang, Nan" sort="Wang, Nan" uniqKey="Wang N" first="Nan" last="Wang">Nan Wang</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Yin, Wei Dong" sort="Yin, Wei Dong" uniqKey="Yin W" first="Wei-Dong" last="Yin">Wei-Dong Yin</name><affiliation wicri:level="1"><mods:affiliation>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation></author><author><name sortKey="Dong, Xiao Ping" sort="Dong, Xiao Ping" uniqKey="Dong X" first="Xiao-Ping" last="Dong">Xiao-Ping Dong</name><affiliation wicri:level="1"><mods:affiliation>State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China</mods:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea></affiliation><affiliation><mods:affiliation>E-mail: dongxp238@sina.com</mods:affiliation></affiliation><affiliation><mods:affiliation>Reprints or correspondence: Dr. Xiao-Ping Dong, Ying-Xin Rd. 100, Beijing (100052), People' Republic of China (dongxp238@sina.com); or Dr. Wei-Dong Yin, No.39 Shangdi Western Road, Haidian District, Beijing (100085), People's Republic of China (yinweidong@sinovac.com).</mods:affiliation></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="2009-04-15">2009</date><biblScope unit="vol">48</biblScope><biblScope unit="issue">8</biblScope><biblScope unit="page" from="1087">1087</biblScope><biblScope unit="page" to="1095">1095</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. Avian influenza A virus H5N1 has the potential to cause a pandemic. Adjuvants and whole-virion vaccines are regarded as antigen sparing for pandemic vaccines. Methods. A double-blind, randomized trial was performed from 28 August to 22 December 2007 in 402 adults; 301 adults were randomly assigned to receive 2 doses of an inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine containing 5, 10, or 15 μg of hemagglutinin per dose 28 days apart, and 101 of them received 2 doses of 10 μg of vaccine 14 days apart. The vaccine was manufactured from the recombinant A/Vietman/1194/2004 (NIBRG14) strain. Blood samples were collected for hemagglutination inhibition and microneutralization assays. Results. All formulations were well tolerated, with no serious adverse events. Most local and systemic reactions were mild or moderate. Immune responses were induced after 1 dose in all vaccination groups. The highest immune response was seen after 2 doses of 15 μg of vaccine, with 90% and 100% seroconversion rates and 90% and 100% of participants having a titer of ⩾1:40 for hemagglutination inhibition and microneutralization assays, respectively. Both the 10- and 15-μg doses met or exceeded European Union licensure criteria. Generally, higher immune responses were elicited in participants vaccinated 28 days apart than those vaccinated 14 days apart. Cross-reaction assays showed that after 2 doses of 10 μg of vaccine, 98% and 87% of participants had a microneutralization titer of ⩾1:40 against heterologous Indonesia and Anhui strains, respectively. Conclusions. The inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine not only showed good immunogenicity and safety but also elicited significant cross-reactivity against heterologous H5N1 strains in clade 2. Trial registration. ClinicalTrials.gov identifier: NCT00535665.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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