https://scholars.lib.ntu.edu.tw/handle/123456789/566377
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.author | LI-MIN HUANG | en_US |
dc.contributor.author | Chiu C.-H. | en_US |
dc.contributor.author | Chiu N.-C. | en_US |
dc.contributor.author | Lin C.-Y. | en_US |
dc.contributor.author | Li M.-T. | en_US |
dc.contributor.author | Kuo T.-Y. | en_US |
dc.contributor.author | Weng Y.-J. | en_US |
dc.contributor.author | Hsieh E.-F. | en_US |
dc.contributor.author | Tai I.-C. | en_US |
dc.creator | Li-Min Huang;Chiu C.-H.;Chiu N.-C.;Lin C.-Y.;Li M.-T.;Kuo T.-Y.;Weng Y.-J.;Hsieh E.-F.;Tai I.-C. | - |
dc.date.accessioned | 2021-06-24T07:16:12Z | - |
dc.date.available | 2021-06-24T07:16:12Z | - |
dc.date.issued | 2019 | - |
dc.identifier.issn | 0264-410X | - |
dc.identifier.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85061823857&doi=10.1016%2fj.vaccine.2019.02.023&partnerID=40&md5=d04466a1fad13a888a1fdb0d8152abd0 | - |
dc.identifier.uri | https://scholars.lib.ntu.edu.tw/handle/123456789/566377 | - |
dc.description.abstract | Background: To fight against enterovirus A71 (EV-A71)-associated diseases, vaccine development was initiated in Taiwan focusing on two-month-old infants. Methods: We conducted a phase II, double-blind, randomised, placebo-controlled study on infants and children aged two months to 11 years. This study was conducted in 4 parts (2a, 2b, 2c, and 2d) with age de-escalation sequentially. Two doses were administered with a 28-day or 56-day interval. Participants aged two months to <two years received a booster dose at one year after the first dose. During the surveillance period, solicited adverse events (AEs) and unsolicited AEs were recorded for safety evaluation. Blood samples were collected for neutralising antibody assay at various times. Immune persistence and booster effects were also assessed. Results: A total of 363 children completed the study. Most AEs were mild and unrelated to treatment. No vaccine-related serious adverse events (SAEs) were reported. Geometric mean titres (GMTs) of serum neutralising antibody titres increased profoundly. Most participants in the vaccine groups achieved defined seroprotection (neutralization titre ? 1:32) after the second vaccination and persisted for two years. Furthermore, the EV-A71 vaccine could provide a cross-reaction against other EV-A71 strain genotypes: B5, C4a, C4b, and C5. Conclusions: The mid dose of the EV-A71 vaccine elicited high immune response and were tolerable in participants aged between two months and 11 years in all dosing groups. ? 2019 Elsevier Ltd | - |
dc.publisher | Elsevier Ltd | - |
dc.relation.ispartof | Vaccine | - |
dc.subject | Cross-reaction; EV-A71 vaccine; Immune persistence; Immunogenicity; Two-month-old infant | - |
dc.subject.classification | [SDGs]SDG3 | - |
dc.subject.other | enterovirus A71 vaccine; neutralizing antibody; placebo; unclassified drug; virus vaccine; inactivated vaccine; neutralizing antibody; vaccine; virus antibody; virus vaccine; antibody titer; arthralgia; Article; child; controlled study; cross reaction; diarrhea; double blind procedure; drug dose escalation; drug megadose; drug safety; drug tolerability; ecchymosis; Enterovirus A71; fatigue; fever; headache; human; immunogenicity; infant; loss of appetite; low drug dose; myalgia; nausea and vomiting; pain; phase 2 clinical trial; preschool child; priority journal; randomized controlled trial; seroconversion; shivering; side effect; single drug dose; swelling; Taiwan; age; clinical trial; Enterovirus A; Enterovirus infection; female; immunization; immunology; male; outcome assessment; vaccination; vaccine immunogenicity; Age Factors; Antibodies, Neutralizing; Antibodies, Viral; Child; Child, Preschool; Cross Reactions; Enterovirus A, Human; Enterovirus Infections; Female; Humans; Immunization Schedule; Immunogenicity, Vaccine; Infant; Male; Patient Outcome Assessment; Taiwan; Vaccination; Vaccine Potency; Vaccines, Inactivated; Viral Vaccines | - |
dc.title | Immunogenicity, safety, cross-reaction, and immune persistence of an inactivated enterovirus A71 vaccine in children aged from two months to 11 years in Taiwan | en_US |
dc.type | journal article | en |
dc.identifier.doi | 10.1016/j.vaccine.2019.02.023 | - |
dc.identifier.pmid | 30803843 | - |
dc.identifier.scopus | 2-s2.0-85061823857 | - |
dc.relation.pages | 1827-1835 | - |
dc.relation.journalvolume | 37 | - |
dc.relation.journalissue | 13 | - |
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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