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J-GLOBAL ID：202202232654296178   整理番号：22A0660123

インフルエンザウイルス:フェリチンナノ粒子H2インフルエンザワクチンの健康な成人での安全性と免疫原性:第1相試験

Safety and immunogenicity of a ferritin nanoparticle H2 influenza vaccine in healthy adults: a phase 1 trial

著者 (76件)： HOUSER Katherine V. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CHEN Grace L. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CARTER Cristina (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CRANK Michelle C. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  NGUYEN Thuy A. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  FLOREZ Maria Claudia Burgos (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  BERKOWITZ Nina M. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  MENDOZA Floreliz (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  HENDEL Cynthia Starr (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  GORDON Ingelise J. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  COATES Emily E. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  VAZQUEZ Sandra (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  STEIN Judy (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  LAWLOR Heather (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CARLTON Kevin (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  GAUDINSKI Martin R. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  STROM Larisa (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  HOFSTETTER Amelia R. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  NARPALA Sandeep (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  HATCHER Christian (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  GILLESPIE Rebecca A. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CREANGA Adrian (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  KANEKIYO Masaru (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  RAAB Julie E. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  ANDREWS Sarah F. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  ZHANG Yi (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  YANG Eun Sung (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  WANG Lingshu (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  LEUNG Kwanyee (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  KONG Wing-Pui (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  BAILER Robert T. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  MCDERMOTT Adrian B. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  KOUP Richard A. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  GALL Jason G. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  ARNOLD Frank (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  MASCOLA John R. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  GRAHAM Barney S. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  LEDGERWOOD Julie E. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CASAZZA Joseph (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  HOLMAN Lasonji (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  OLA Abidemi O. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  COSTNER Pamela (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CUNNINGHAM Jennifer (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  LARKIN Brenda (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  NOVIK Laura (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  SAUNDERS Jamie (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  WHALEN William (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  WANG Xiaolin (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  ESHUN Aba Mensima (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  TAYLOR Alison (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CHENG K. C. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  LAURENCOT Carolyn (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  COX Josephine H. (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  SITAR Sandra (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  LE Lam (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  PITTMAN Iris (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  VASILENKO Olga (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  ROTHWELL Ro Shauna (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  YAMSHCHIKOV Galina (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  BURCH Eugenia (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  HICKMAN Somia (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  TROFYMENKO Olga (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  BOYD Catina (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  APTE Preeti (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CARTAGENA Cora Trelles (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  HICKS Renunda (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  WILLIAMS Pernell (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  BLAKU Zana (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  TRAN Colin (Vaccine Res. Center, National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  CASE Christopher L. (Vaccine Clinical Materials Program, Leidos Biomedical Res., Inc., Frederick National Lab. for Cancer Res., Frederick, MD, USA) ,  GAUDINSKI Martin R. (Commissioned Corps, U.S. Public Health Serv., Rockville, MD, USA) ,  LIANG C. Jason (Biostatistics Res. Branch, Div. of Clinical Res., National Inst. of Allergy and Infectious Diseases, National Inst. of Health, Bethesda, MD, USA) ,  FREYN Alec W. (Dep. of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA) ,  PALESE Peter (Dep. of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA) ,  NACHBAGAUER Raffael (Dep. of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA) ,  PALESE Peter (Dep. of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA)
資料名： Nature Medicine  (Nature Medicine)
巻： 28  号： 2  ページ： 383-391  発行年： 2022年02月 
JST資料番号： W0636A  ISSN： 1078-8956  資料種別： 逐次刊行物 (A)
記事区分： 原著論文  発行国： アメリカ合衆国 (USA)  言語： 英語 (EN)

抄録/ポイント： 現在,承認されている季節性インフルエンザワクチンは有効性がさまざまであり,インフルエンザのサブタイプ間で保存されているウイルスタンパク質ドメインに対して,もっと幅広い応答を誘導できる新しいワクチンプラットフォームが必要とされている。我々は,新規なフェリチン(H2HA-フェリチン)ナノ粒子インフルエンザワクチンのプラットフォームを評価するために,FIH(first-in-human)無作為化非盲検第1相臨床試験(NCT03186781)を行った。H2サブタイプはヒトでは1968年以来流行していないので,1968年以降に生まれた成人は,グループ1インフルエンザウイルスのH1サブタイプのみに曝露されているが,H1とH2には共通の保存されたHA幹部がある。この臨床試験にはH2未曝露の成人とH2に曝露されたことがある成人の両方を含めることで,免疫優性なHA頭部ドメインに対する既存の応答が存在する場合と存在しない場合について,保存されたHA幹部ドメインに対する記憶応答を評価することが可能になった。18~70歳の健康な参加者50人を対象に,H2HA-フェリチンの筋肉内投与を,投与量20μgの単回投与(n=5),投与量60μgの同種ワクチン2回投与によるプライム-ブーストレジメン(n=25),またはマッチした型のH2DNAワクチンによるプライム後にH2HA-フェリチン60μgでの2回目投与を行う異種ワクチンによるプライム-ブーストレジメン(n=20)を行った。この試験の主要目的は,H2HA-フェリチンの単独,もしくはプライム-ブーストレジメンでの安全性と耐容性の評価であった。副次的目的は,ワクチン接種後の抗体応答の評価であった。ワクチンは共に安全で耐容性が良好であり,依頼に基づく(非自発的な)症状で最も一般的なものは,H2HA-フェリチン(n=15,22%)およびH2DNA(n=5,25%)の両方で,接種後の軽度な頭痛であった。探索的解析から,H2未曝露集団とH2曝露集団の両方で,H2HA-フェリチンワクチンによって中和抗体応答が誘導されることが明らかになった。また,HA幹部を標的とすることにより,H2未曝露集団では,グループ1インフルエンザウイルス(季節性H1サブタイプと鳥類H5サブタイプの両方を含む)に対する広域中和抗体応答が誘導された。このフェリチンナノ粒子ワクチン技術は,パンデミック(世界的大流行)への備えやユニバーサルインフルエンザワクチンの開発に使える可能性のある,新規で安全,かつ免疫原性のあるプラットフォームである。Copyright Nature Japan KK 2022

シソーラス用語： *安全性 ,  *インフルエンザウイルス ,  頭痛 ,  ヒト ,  *フェリチン ,  *ワクチン ,  *インフルエンザ ,  *免疫原性 ,  予防接種 ,  *第一相試験 ,  *インフルエンザワクチン ,  単回投与 ,  中和抗体 ,  *ナノ粒子 ,  忍容性

分類 (2件)： 免疫療法薬・血液製剤の基礎研究  (GW22010D) ,  感染免疫  (ED03030P)

タイトルに関連する用語 (9件)： インフルエンザウイルス ,  フェリチン ,  ナノ粒子 ,  H2 ,  インフルエンザワクチン ,  成人 ,  安全性 ,  免疫原性 ,  第1相試験