A Booster Dose of an Inactivated Enterovirus 71 Vaccine in Chinese Young Children: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Background. A significant waning of enterovirus 71 (EV71) antibody titer after priming immunization with an inactivated EV71 vaccine implied the potential need for a booster dose. Methods. In this randomized, double-blind, placebo-controlled clinical trial, we recruited participants who had received...
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| Veröffentlicht in: | The Journal of infectious diseases 2014-10, Vol.210 (7), p.1073-1082 |
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| creator | Shenyu, Wang Jingxin, Li Zhenglun, Liang Xiuling, Li Qunying, Mao Fanyue, Meng Hua, Wang Yuntao, Zhang Fan, Gao Qinghua, Chen Yuemei, Hu Xin, Yao Huijie, Guo Fengcai, Zhu |
| description | Background. A significant waning of enterovirus 71 (EV71) antibody titer after priming immunization with an inactivated EV71 vaccine implied the potential need for a booster dose. Methods. In this randomized, double-blind, placebo-controlled clinical trial, we recruited participants who had received at least 1 dose of priming EV71 vaccine in an early phase 2 clinical trial that was conducted in healthy infants and children aged 6-35 months. All participants were grouped according to the priming EV71 vaccine formulations (160 U, 320 U, and 640 U with adjuvant and 640 U without adjuvant) and then randomly assigned (ratio, 2:1) to receive a booster dose of vaccine or placebo within each formulation group. The primary end point was the geometric mean titer 28 days after the booster dose. Results. A total of 773 participants were enrolled. Significantly greater immunological responses were induced by the booster shot of all 4 formulations of EV71 vaccine, compared with that induced by placebo (P |
| doi_str_mv | 10.1093/infdis/jiu113 |
| format | Article |
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A significant waning of enterovirus 71 (EV71) antibody titer after priming immunization with an inactivated EV71 vaccine implied the potential need for a booster dose. Methods. In this randomized, double-blind, placebo-controlled clinical trial, we recruited participants who had received at least 1 dose of priming EV71 vaccine in an early phase 2 clinical trial that was conducted in healthy infants and children aged 6-35 months. All participants were grouped according to the priming EV71 vaccine formulations (160 U, 320 U, and 640 U with adjuvant and 640 U without adjuvant) and then randomly assigned (ratio, 2:1) to receive a booster dose of vaccine or placebo within each formulation group. The primary end point was the geometric mean titer 28 days after the booster dose. Results. A total of 773 participants were enrolled. Significantly greater immunological responses were induced by the booster shot of all 4 formulations of EV71 vaccine, compared with that induced by placebo (P <.0001). The frequencies of adverse reactions were similar between vaccine and placebo groups within each formulation group. Conclusions. A booster dose of EV71 vaccine 1 year after the priming EV71 immunization shows excellent immunogenicity and good safety profile. Clinical Trials Registration. NCT01734408.</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1093/infdis/jiu113</identifier><identifier>PMID: 24625805</identifier><language>eng</language><publisher>United States: Oxford University Press</publisher><subject>Antibodies ; Antibodies, Viral - blood ; Asian Continental Ancestry Group ; Child, Preschool ; Clinical trials ; Dosage ; Double-Blind Method ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Drug-Related Side Effects and Adverse Reactions - pathology ; Enterovirus ; Enterovirus A, Human - immunology ; Enterovirus Infections - prevention & control ; Female ; Humans ; Immune response ; Immunization, Secondary - adverse effects ; Immunization, Secondary - methods ; Inactivated poliovirus vaccines ; Inactivated vaccines ; Infant ; Male ; Placebos ; Placebos - administration & dosage ; Poliovirus vaccines ; Vaccination ; Vaccines, Inactivated - administration & dosage ; Vaccines, Inactivated - adverse effects ; Vaccines, Inactivated - immunology ; Viral Vaccines - administration & dosage ; Viral Vaccines - adverse effects ; Viral Vaccines - immunology ; VIRUSES</subject><ispartof>The Journal of infectious diseases, 2014-10, Vol.210 (7), p.1073-1082</ispartof><rights>Copyright © 2014 Oxford University Press on behalf of the Infectious Diseases Society of America</rights><rights>The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c387t-738b2919c31a522dbee1d9d6ac0a3323ebe98945f705764ba1df424ff4711d393</citedby><cites>FETCH-LOGICAL-c387t-738b2919c31a522dbee1d9d6ac0a3323ebe98945f705764ba1df424ff4711d393</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/43708196$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/43708196$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>315,781,785,804,27929,27930,58022,58255</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24625805$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shenyu, Wang</creatorcontrib><creatorcontrib>Jingxin, Li</creatorcontrib><creatorcontrib>Zhenglun, Liang</creatorcontrib><creatorcontrib>Xiuling, Li</creatorcontrib><creatorcontrib>Qunying, Mao</creatorcontrib><creatorcontrib>Fanyue, Meng</creatorcontrib><creatorcontrib>Hua, Wang</creatorcontrib><creatorcontrib>Yuntao, Zhang</creatorcontrib><creatorcontrib>Fan, Gao</creatorcontrib><creatorcontrib>Qinghua, Chen</creatorcontrib><creatorcontrib>Yuemei, Hu</creatorcontrib><creatorcontrib>Xin, Yao</creatorcontrib><creatorcontrib>Huijie, Guo</creatorcontrib><creatorcontrib>Fengcai, Zhu</creatorcontrib><title>A Booster Dose of an Inactivated Enterovirus 71 Vaccine in Chinese Young Children: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial</title><title>The Journal of infectious diseases</title><addtitle>J Infect Dis</addtitle><description>Background. A significant waning of enterovirus 71 (EV71) antibody titer after priming immunization with an inactivated EV71 vaccine implied the potential need for a booster dose. Methods. In this randomized, double-blind, placebo-controlled clinical trial, we recruited participants who had received at least 1 dose of priming EV71 vaccine in an early phase 2 clinical trial that was conducted in healthy infants and children aged 6-35 months. All participants were grouped according to the priming EV71 vaccine formulations (160 U, 320 U, and 640 U with adjuvant and 640 U without adjuvant) and then randomly assigned (ratio, 2:1) to receive a booster dose of vaccine or placebo within each formulation group. The primary end point was the geometric mean titer 28 days after the booster dose. Results. A total of 773 participants were enrolled. Significantly greater immunological responses were induced by the booster shot of all 4 formulations of EV71 vaccine, compared with that induced by placebo (P <.0001). The frequencies of adverse reactions were similar between vaccine and placebo groups within each formulation group. Conclusions. A booster dose of EV71 vaccine 1 year after the priming EV71 immunization shows excellent immunogenicity and good safety profile. Clinical Trials Registration. NCT01734408.</description><subject>Antibodies</subject><subject>Antibodies, Viral - blood</subject><subject>Asian Continental Ancestry Group</subject><subject>Child, Preschool</subject><subject>Clinical trials</subject><subject>Dosage</subject><subject>Double-Blind Method</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Drug-Related Side Effects and Adverse Reactions - pathology</subject><subject>Enterovirus</subject><subject>Enterovirus A, Human - immunology</subject><subject>Enterovirus Infections - prevention & control</subject><subject>Female</subject><subject>Humans</subject><subject>Immune response</subject><subject>Immunization, Secondary - adverse effects</subject><subject>Immunization, Secondary - methods</subject><subject>Inactivated poliovirus vaccines</subject><subject>Inactivated vaccines</subject><subject>Infant</subject><subject>Male</subject><subject>Placebos</subject><subject>Placebos - administration & dosage</subject><subject>Poliovirus vaccines</subject><subject>Vaccination</subject><subject>Vaccines, Inactivated - administration & dosage</subject><subject>Vaccines, Inactivated - adverse effects</subject><subject>Vaccines, Inactivated - immunology</subject><subject>Viral Vaccines - administration & dosage</subject><subject>Viral Vaccines - adverse effects</subject><subject>Viral Vaccines - immunology</subject><subject>VIRUSES</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkUFv1DAQhS1ERZfCkSPIRw6EeuLEjrltQ4FKlYpQQeIUOfYEvPLarZ1Uor-Cn4yrlJ57mhm9b95I8wh5Bew9MMWPXZisy8c7twDwJ2QDLZeVEMCfkg1jdV1Bp9QheZ7zjjHWcCGfkcO6EXXbsXZD_m7pSYx5xkQ_xow0TlQHeha0md2NntHS01DEeOPSkqkE-kMb4wJSF2j_uzRl52dcwq-7yduE4QPd0m862Lh3t2jfFdtl9FideBfK9NVrg2Os-hjmFL0vB_qiOKM9vUxO-xfkYNI-48v7ekS-fzq97L9U5xefz_rteWV4J-dK8m6sFSjDQbd1bUdEsMoKbZjmvOY4oupU006StVI0owY7NXUzTY0EsFzxI_J29b1K8XrBPA97lw16rwPGJQ8goIOWMfkItBXl90wyKGi1oibFnBNOw1Vye53-DMCGu7yGNa9hzavwb-6tl3GP9oH-H1ABXq_ALs8xPegNl6wDJfg_tPub9w</recordid><startdate>20141001</startdate><enddate>20141001</enddate><creator>Shenyu, Wang</creator><creator>Jingxin, Li</creator><creator>Zhenglun, Liang</creator><creator>Xiuling, Li</creator><creator>Qunying, Mao</creator><creator>Fanyue, Meng</creator><creator>Hua, Wang</creator><creator>Yuntao, Zhang</creator><creator>Fan, Gao</creator><creator>Qinghua, Chen</creator><creator>Yuemei, Hu</creator><creator>Xin, Yao</creator><creator>Huijie, Guo</creator><creator>Fengcai, Zhu</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope></search><sort><creationdate>20141001</creationdate><title>A Booster Dose of an Inactivated Enterovirus 71 Vaccine in Chinese Young Children: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial</title><author>Shenyu, Wang ; Jingxin, Li ; Zhenglun, Liang ; Xiuling, Li ; Qunying, Mao ; Fanyue, Meng ; Hua, Wang ; Yuntao, Zhang ; Fan, Gao ; Qinghua, Chen ; Yuemei, Hu ; Xin, Yao ; Huijie, Guo ; Fengcai, Zhu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c387t-738b2919c31a522dbee1d9d6ac0a3323ebe98945f705764ba1df424ff4711d393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Antibodies</topic><topic>Antibodies, Viral - blood</topic><topic>Asian Continental Ancestry Group</topic><topic>Child, Preschool</topic><topic>Clinical trials</topic><topic>Dosage</topic><topic>Double-Blind Method</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Drug-Related Side Effects and Adverse Reactions - pathology</topic><topic>Enterovirus</topic><topic>Enterovirus A, Human - immunology</topic><topic>Enterovirus Infections - prevention & control</topic><topic>Female</topic><topic>Humans</topic><topic>Immune response</topic><topic>Immunization, Secondary - adverse effects</topic><topic>Immunization, Secondary - methods</topic><topic>Inactivated poliovirus vaccines</topic><topic>Inactivated vaccines</topic><topic>Infant</topic><topic>Male</topic><topic>Placebos</topic><topic>Placebos - administration & dosage</topic><topic>Poliovirus vaccines</topic><topic>Vaccination</topic><topic>Vaccines, Inactivated - administration & dosage</topic><topic>Vaccines, Inactivated - adverse effects</topic><topic>Vaccines, Inactivated - immunology</topic><topic>Viral Vaccines - administration & dosage</topic><topic>Viral Vaccines - adverse effects</topic><topic>Viral Vaccines - immunology</topic><topic>VIRUSES</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shenyu, Wang</creatorcontrib><creatorcontrib>Jingxin, Li</creatorcontrib><creatorcontrib>Zhenglun, Liang</creatorcontrib><creatorcontrib>Xiuling, Li</creatorcontrib><creatorcontrib>Qunying, Mao</creatorcontrib><creatorcontrib>Fanyue, Meng</creatorcontrib><creatorcontrib>Hua, Wang</creatorcontrib><creatorcontrib>Yuntao, Zhang</creatorcontrib><creatorcontrib>Fan, Gao</creatorcontrib><creatorcontrib>Qinghua, Chen</creatorcontrib><creatorcontrib>Yuemei, Hu</creatorcontrib><creatorcontrib>Xin, Yao</creatorcontrib><creatorcontrib>Huijie, Guo</creatorcontrib><creatorcontrib>Fengcai, Zhu</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shenyu, Wang</au><au>Jingxin, Li</au><au>Zhenglun, Liang</au><au>Xiuling, Li</au><au>Qunying, Mao</au><au>Fanyue, Meng</au><au>Hua, Wang</au><au>Yuntao, Zhang</au><au>Fan, Gao</au><au>Qinghua, Chen</au><au>Yuemei, Hu</au><au>Xin, Yao</au><au>Huijie, Guo</au><au>Fengcai, Zhu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Booster Dose of an Inactivated Enterovirus 71 Vaccine in Chinese Young Children: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial</atitle><jtitle>The Journal of infectious diseases</jtitle><addtitle>J Infect Dis</addtitle><date>2014-10-01</date><risdate>2014</risdate><volume>210</volume><issue>7</issue><spage>1073</spage><epage>1082</epage><pages>1073-1082</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><abstract>Background. A significant waning of enterovirus 71 (EV71) antibody titer after priming immunization with an inactivated EV71 vaccine implied the potential need for a booster dose. Methods. In this randomized, double-blind, placebo-controlled clinical trial, we recruited participants who had received at least 1 dose of priming EV71 vaccine in an early phase 2 clinical trial that was conducted in healthy infants and children aged 6-35 months. All participants were grouped according to the priming EV71 vaccine formulations (160 U, 320 U, and 640 U with adjuvant and 640 U without adjuvant) and then randomly assigned (ratio, 2:1) to receive a booster dose of vaccine or placebo within each formulation group. The primary end point was the geometric mean titer 28 days after the booster dose. Results. A total of 773 participants were enrolled. Significantly greater immunological responses were induced by the booster shot of all 4 formulations of EV71 vaccine, compared with that induced by placebo (P <.0001). The frequencies of adverse reactions were similar between vaccine and placebo groups within each formulation group. Conclusions. A booster dose of EV71 vaccine 1 year after the priming EV71 immunization shows excellent immunogenicity and good safety profile. Clinical Trials Registration. NCT01734408.</abstract><cop>United States</cop><pub>Oxford University Press</pub><pmid>24625805</pmid><doi>10.1093/infdis/jiu113</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; JSTOR Archive Collection A-Z Listing; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Antibodies Antibodies, Viral - blood Asian Continental Ancestry Group Child, Preschool Clinical trials Dosage Double-Blind Method Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - pathology Enterovirus Enterovirus A, Human - immunology Enterovirus Infections - prevention & control Female Humans Immune response Immunization, Secondary - adverse effects Immunization, Secondary - methods Inactivated poliovirus vaccines Inactivated vaccines Infant Male Placebos Placebos - administration & dosage Poliovirus vaccines Vaccination Vaccines, Inactivated - administration & dosage Vaccines, Inactivated - adverse effects Vaccines, Inactivated - immunology Viral Vaccines - administration & dosage Viral Vaccines - adverse effects Viral Vaccines - immunology VIRUSES |
| title | A Booster Dose of an Inactivated Enterovirus 71 Vaccine in Chinese Young Children: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
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