https://scholars.lib.ntu.edu.tw/handle/123456789/515765
標題: | A randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with adjuvant LTh(αK): A phase I study | 作者: | SUNG-CHING PAN SZU-MIN HSIEH CHIH-FENG LIN Hsu Y.-S. Chang M. SHAN-CHWEN CHANG |
公開日期: | 2019 | 出版社: | Elsevier Ltd | 卷: | 37 | 期: | 14 | 起(迄)頁: | 1994-2003 | 來源出版物: | Vaccine | 摘要: | Background: A nasal influenza vaccine has been available only in a live attenuated form, which limits the range of recipients to immune-competent individuals. The present study evaluated a newly developed intranasal inactivated influenza vaccine with a novel adjuvant, heat-labile enterotoxin (LT) derived from E. coli (LTh(αK)). Methods: The study was a randomized, double-blind, controlled phase I trial to evaluate the safety and immunogenicity of an intranasal vaccine containing the trivalent influenza HA antigen (7.5 ?g each of A/California/7/09 (H1N1)-like virus, A/Victoria/210/2009 (H3N2) virus, and B/Brisbane/60/2008-like virus) in combination with 4 different doses of adjuvant LTh(αK) (7.5, 15, 30 or 45 μg) and 22.5 μg of influenza HA antigen alone (control vaccine). The vaccine was intranasally administered on Days 0 and 7. A safety evaluation commenced for 180 days, and hemagglutination inhibition (HI) antibody titers and nasal HA-specific IgA titers on Day 0 and Day 28 were assessed to determine whether an immunogenic response was elicited. Results: From November 2012 to September 2013, a total of 36 subjects were enrolled. Twenty-four subjects received an adjuvanted vaccine, and 12 subjects received a control vaccine. The most common adverse event (AE) was mild nasal discomfort, and systemic AEs were mild fatigue and headache. Only two subjects discontinued the study because of an AE (one had grade 3 fever, and one had nodal arrhythmia). In the group with 45 μg of LTh(αK), the seroprotection rates were 100%, 100% and 80%, and the nasal IgA conversion factors were 7.90, 7.46 and 12.27 for the A/H3N2, A/H1N1 and split B strains, respectively. Adjuvant LTh(αK) vaccine showed a significant enhancement in mucosal immunity in split B -specific IgA. Conclusion: The intranasal inactivated influenza vaccine is generally safe, and the LTh(αK)-adjuvanted vaccine is more immunogenic than non-adjuvanted control vaccine. ClinicalTrials.gov Identifier: NCT03293732. ? 2019 Elsevier Ltd |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85062228344&doi=10.1016%2fj.vaccine.2019.02.006&partnerID=40&md5=84fbea53376e5346ced15ca25833e5dc https://scholars.lib.ntu.edu.tw/handle/123456789/515765 |
ISSN: | 0264-410X | DOI: | 10.1016/j.vaccine.2019.02.006 | SDG/關鍵字: | dcb 07030; immunoglobulin A; immunological adjuvant; influenza vaccine; labile enterotoxin(alpha k); unclassified drug; immunoglobulin A; immunological adjuvant; inactivated vaccine; influenza vaccine; virus antibody; adjuvant therapy; adult; antibody titer; Article; atrioventricular junction arrhythmia; cohort analysis; controlled study; disease severity; dizziness; dose response; double blind procedure; drug safety; drug withdrawal; fatigue; female; fever; headache; hemagglutination inhibition; hematuria; human; human experiment; hypotension; immune response; immunological parameters; male; mucosal immunity; nasal discomfort; normal human; nose disease; phase 1 clinical trial; randomized controlled trial; risk assessment; seroconversion; seroconversion rate; seroprotection rate; treatment duration; vaccine immunogenicity; clinical trial; hemagglutination inhibition test; immunology; influenza; intranasal drug administration; methodology; young adult; Adjuvants, Immunologic; Administration, Intranasal; Adult; Antibodies, Viral; Female; Hemagglutination Inhibition Tests; Humans; Immunogenicity, Vaccine; Immunoglobulin A; Influenza Vaccines; Influenza, Human; Male; Outcome Assessment, Health Care; Research Design; Vaccines, Inactivated; Young Adult |
顯示於: | 醫學系 |
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