https://scholars.lib.ntu.edu.tw/handle/123456789/589576
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.author | Kim J.H. | en_US |
dc.contributor.author | Drame M. | en_US |
dc.contributor.author | Puthanakit T. | en_US |
dc.contributor.author | Chiu N.-C. | en_US |
dc.contributor.author | Supparatpinyo K. | en_US |
dc.contributor.author | LI-MIN HUANG | en_US |
dc.contributor.author | Chiu C.-H. | en_US |
dc.contributor.author | Chen P.-Y. | en_US |
dc.contributor.author | Hwang K.-P. | en_US |
dc.contributor.author | Danier J. | en_US |
dc.contributor.author | Friel D. | en_US |
dc.contributor.author | Salaun B. | en_US |
dc.contributor.author | Woo W. | en_US |
dc.contributor.author | Vaughn D.W. | en_US |
dc.contributor.author | Innis B. | en_US |
dc.contributor.author | Schuind A. | en_US |
dc.date.accessioned | 2021-12-06T06:46:01Z | - |
dc.date.available | 2021-12-06T06:46:01Z | - |
dc.date.issued | 2021 | - |
dc.identifier.issn | 0891-3668 | - |
dc.identifier.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85112751314&doi=10.1097%2fINF.0000000000003247&partnerID=40&md5=ec910cd8ff42c2e43abe8990e6aae4f5 | - |
dc.identifier.uri | https://scholars.lib.ntu.edu.tw/handle/123456789/589576 | - |
dc.description.abstract | Background: This phase 2 observer-blind, randomized, multicenter, dose-ranging study evaluated immunogenicity and safety of different formulations of an AS03-adjuvanted H5N1 influenza vaccine in children 6-35 months of age. Methods: One hundred eighty-five children randomized into 5 groups [1.9 ?g hemagglutinin (HA)/AS03B, 0.9 ?g HA/AS03C, 1.9 ?g HA/AS03C, 3.75 ?g HA/AS03Cor 3.75 ?g HA/AS03D] were to receive 2 doses administered 21 days apart (primary vaccination). AS03 was classified by amount of DL-a-tocopherol, with AS03Bthe highest amount. One year later, all subjects were to receive unadjuvanted 3.75 ?g HA as antigen challenge. Immunogenicity was assessed 21 days after primary vaccination (day 42) and 7 days after antigen challenge (day 392). Immunogenicity-fever index, based on hemagglutination inhibition and microneutralization antibody titers at day 42 and fever 7 days after each vaccination, was used to guide the selection of an acceptable formulation. Results: After primary vaccination, formulations elicited strong homologous immune responses with all subjects' hemagglutination inhibition titers =1:40 post-vaccination. Immunogenicity-fever index based on hemagglutination inhibition and microneutralization assays showed that 1.9 ?g HA/AS03Branked the highest. Antibody levels persisted >4 times above baseline 12 months after primary vaccination with all formulations (day 385). Antibodies increased >4-fold after antigen challenge (day 392/day 385) with 1.9 ?g HA/AS03B, 0.9 ?g HA/AS03Cand 1.9 ?g HA/AS03Cformulations. Overall per subject, the incidence of fever ranged from 28.6% (3.75 ?g HA/AS03D) to 60.5% (1.9 ?g HA/AS03B). Conclusions: All formulations were highly immunogenic and demonstrated acceptable safety profiles, with the 1.9 ?g HA/AS03Bproviding the most favorable balance of immunogenicity versus reactogenicity for use in children 6-35 months of age. ? 2021 Lippincott Williams and Wilkins. All rights reserved. | - |
dc.publisher | Lippincott Williams and Wilkins | - |
dc.relation.ispartof | Pediatric Infectious Disease Journal | - |
dc.subject | AS03; children; dose finding; H5N1; influenza vaccine | - |
dc.subject.classification | [SDGs]SDG3 | - |
dc.subject.other | immunological adjuvant; influenza vaccine; virus antibody; blood; clinical trial; controlled study; dose response; female; human; immunology; infant; influenza; Influenza A virus (H5N1); male; multicenter study; phase 2 clinical trial; preschool child; randomized controlled trial; vaccine immunogenicity; Adjuvants, Immunologic; Antibodies, Viral; Child, Preschool; Dose-Response Relationship, Immunologic; Female; Humans; Immunogenicity, Vaccine; Infant; Influenza A Virus, H5N1 Subtype; Influenza Vaccines; Influenza, Human; Male | - |
dc.title | Immunogenicity and Safety of AS03-adjuvanted H5N1 Influenza Vaccine in Children 6-35 Months of Age: Results from a Phase 2, Randomized, Observer-blind, Multicenter, Dose-ranging Study | en_US |
dc.type | journal article | en |
dc.identifier.doi | 10.1097/INF.0000000000003247 | - |
dc.identifier.pmid | 34285165 | - |
dc.identifier.scopus | 2-s2.0-85112751314 | - |
dc.relation.pages | E333-E339 | - |
item.cerifentitytype | Publications | - |
item.fulltext | no fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_6501 | - |
item.openairetype | journal article | - |
item.grantfulltext | none | - |
crisitem.author.dept | Pediatrics | - |
crisitem.author.dept | Epidemiology and Preventive Medicine | - |
crisitem.author.dept | National Taiwan University Children's Hospital | - |
crisitem.author.dept | Pediatrics-NTUH | - |
crisitem.author.orcid | 0000-0002-9291-260X | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | College of Public Health | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
顯示於: | 醫學系 |
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