Immunogenicity, Safety, and Cross-Reactivity of an Inactivated, Adjuvanted, Prototype Pandemic Influenza (H5N1) Vaccine: A Phase II, Double-Blind, Randomized Trial
Identifieur interne : 001143 ( Main/Exploration ); précédent : 001142; suivant : 001144Immunogenicity, 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.
Url:
DOI: 10.1086/597401
Affiliations:
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H" first="Han-Hua" last="Fang">Han-Hua Fang</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Pékin</settlement></placeName></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="3"><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></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="3"><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><placeName><settlement type="city">Pékin</settlement></placeName></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="3"><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><placeName><settlement type="city">Pékin</settlement></placeName></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="3"><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>National Institute for the Control 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type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Lu, Min" sort="Lu, Min" uniqKey="Lu M" first="Min" last="Lu">Min Lu</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Pékin</settlement></placeName></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="3"><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><placeName><settlement type="city">Pékin</settlement></placeName></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="3"><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Gao, Qiang" sort="Gao, Qiang" uniqKey="Gao Q" first="Qiang" last="Gao">Qiang Gao</name><affiliation wicri:level="3"><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></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="3"><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Wang, Nan" sort="Wang, Nan" uniqKey="Wang N" first="Nan" last="Wang">Nan Wang</name><affiliation wicri:level="3"><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></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="3"><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Sinovac Biotech, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></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="3"><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><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation></affiliation><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><affiliations><list><country><li>République populaire de Chine</li></country><settlement><li>Pékin</li></settlement></list><tree><country name="République populaire de Chine"><noRegion><name sortKey="Wu, Jiang" sort="Wu, Jiang" uniqKey="Wu J" first="Jiang" last="Wu">Jiang Wu</name></noRegion><name sortKey="Chen, Jiang Ting" sort="Chen, Jiang Ting" uniqKey="Chen J" first="Jiang-Ting" last="Chen">Jiang-Ting Chen</name><name sortKey="Dong, Shan Shan" sort="Dong, Shan Shan" uniqKey="Dong S" first="Shan-Shan" last="Dong">Shan-Shan Dong</name><name sortKey="Dong, Xiao Ping" sort="Dong, Xiao Ping" uniqKey="Dong X" first="Xiao-Ping" last="Dong">Xiao-Ping Dong</name><name sortKey="Fang, Han Hua" sort="Fang, Han Hua" uniqKey="Fang H" first="Han-Hua" last="Fang">Han-Hua Fang</name><name sortKey="Feng, Zi Jian" sort="Feng, Zi Jian" uniqKey="Feng Z" first="Zi-Jian" last="Feng">Zi-Jian Feng</name><name sortKey="Gao, Qiang" sort="Gao, Qiang" uniqKey="Gao Q" first="Qiang" last="Gao">Qiang Gao</name><name sortKey="Li, Chang Gui" sort="Li, Chang Gui" uniqKey="Li C" first="Chang-Gui" last="Li">Chang-Gui Li</name><name sortKey="Liu, Li Ying" sort="Liu, Li Ying" uniqKey="Liu L" first="Li-Ying" last="Liu">Li-Ying Liu</name><name sortKey="Liu, Yan" sort="Liu, Yan" uniqKey="Liu Y" first="Yan" last="Liu">Yan Liu</name><name sortKey="Lu, Min" sort="Lu, Min" uniqKey="Lu M" first="Min" last="Lu">Min Lu</name><name sortKey="Qiu, Yuan Zheng" sort="Qiu, Yuan Zheng" uniqKey="Qiu Y" first="Yuan-Zheng" last="Qiu">Yuan-Zheng Qiu</name><name sortKey="Wang, Nan" sort="Wang, Nan" uniqKey="Wang N" first="Nan" last="Wang">Nan Wang</name><name sortKey="Yin, Wei Dong" sort="Yin, Wei Dong" uniqKey="Yin W" first="Wei-Dong" last="Yin">Wei-Dong Yin</name><name sortKey="Zhang, Xiao Mei" sort="Zhang, Xiao Mei" uniqKey="Zhang X" first="Xiao-Mei" last="Zhang">Xiao-Mei Zhang</name><name sortKey="Zhou, Ji Chen" sort="Zhou, Ji Chen" uniqKey="Zhou J" first="Ji-Chen" last="Zhou">Ji-Chen Zhou</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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