Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: A phase IV, randomized, open-label, controlled study
DC Field | Value | Language |
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dc.contributor.author | Izurieta, Patricia | - |
dc.contributor.author | Kim, Woo Joo | - |
dc.contributor.author | Wie, Seong-Heon | - |
dc.contributor.author | Lee, Jacob | - |
dc.contributor.author | Lee, Jin-Soo | - |
dc.contributor.author | Drame, Mamadou | - |
dc.contributor.author | Vaughn, David W. | - |
dc.contributor.author | Schuind, Anne | - |
dc.date.accessioned | 2021-09-04T15:16:15Z | - |
dc.date.available | 2021-09-04T15:16:15Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2015-06-04 | - |
dc.identifier.issn | 0264-410X | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/93286 | - |
dc.description.abstract | Background: AS03-adjuvanted H5N1 pandemic influenza vaccines have been assessed in an extensive clinical development program conducted in North America, Europe, and Asia including children from 6 months of age, adults, and elderly adults. We evaluated AS03-H5N1 in Korean adults 18 through 60 years of age. Methods: This Phase IV, randomized, study was conducted to assess the immunogenicity, reactogenicity, and safety of two doses (3.75 mu g of hemagglutinin antigen) of A/Indonesia/5/2005 (H5N1) adjuvanted with AS03 given 21 days apart in Korean adults. Antibody responses were assessed using hemagglutination-inhibition (HI) assays against the vaccine strain and a vaccine-heterologous strain (A/Vietnam/1194/2004) 21 days after the second dose. A control group (safety) received a licensed seasonal inactivated trivalent influenza vaccine (TIV). Reactogenicity was assessed for 7 days after each vaccination, and unsolicited adverse events were assessed for 182 days following vaccination in both study groups (NCT01730378). Results: AS03-H5N1 was immunogenic and elicited robust HI antibody responses with seroconversion rates of 100% for the vaccine strain and 69.1% for the heterologous strain (N=81). HI antibody responses fulfilled the European licensure criteria for immunogenicity (primary endpoint). The incidence of local and systemic solicited adverse events (reactogenicity) was higher with AS03-H5N1 than TIV. There was no apparent difference in the rate of unsolicited adverse events in the AS03-H5N1 and TIV groups. Conclusion: The results indicate that AS03-H5N1 vaccine is immunogenic with reactogenicity and safety findings that are consistent with the established profile of AS03-H5N1 vaccine. (C) 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.orgflicenses/by-nc-nd/4.0/). | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCI LTD | - |
dc.subject | CROSS-REACTIVE IMMUNITY | - |
dc.subject | VIRUS | - |
dc.subject | RESPONSES | - |
dc.subject | INFANTS | - |
dc.subject | ANTIGEN | - |
dc.title | Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: A phase IV, randomized, open-label, controlled study | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Woo Joo | - |
dc.identifier.doi | 10.1016/j.vaccine.2015.04.027 | - |
dc.identifier.scopusid | 2-s2.0-84929262391 | - |
dc.identifier.wosid | 000355705700012 | - |
dc.identifier.bibliographicCitation | VACCINE, v.33, no.24, pp.2800 - 2807 | - |
dc.relation.isPartOf | VACCINE | - |
dc.citation.title | VACCINE | - |
dc.citation.volume | 33 | - |
dc.citation.number | 24 | - |
dc.citation.startPage | 2800 | - |
dc.citation.endPage | 2807 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.subject.keywordPlus | CROSS-REACTIVE IMMUNITY | - |
dc.subject.keywordPlus | VIRUS | - |
dc.subject.keywordPlus | RESPONSES | - |
dc.subject.keywordPlus | INFANTS | - |
dc.subject.keywordPlus | ANTIGEN | - |
dc.subject.keywordAuthor | AS03 | - |
dc.subject.keywordAuthor | H5N1 vaccine | - |
dc.subject.keywordAuthor | Pandemic influenza | - |
dc.subject.keywordAuthor | Korean adults | - |
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