➥【AZ疫苗混打Moderna疫苗:瑞典88人小型研究報告】:【新英格蘭醫學期刊】於2021年7月14日發表全球第一篇ChAdOx1 (AZ)新冠疫苗混打mRNA-1273 (Moderna)疫苗的研究。
■ 方法
此研究在瑞典進行,共納入88位已在9-12周前接種過第一劑ChAdOx1疫苗的醫護人員,其中37位受試者選擇ChAdOx1疫苗作為第二劑追加疫苗(AZ/AZ組),51位選擇mRNA-1273疫苗(AZ/Moderna組)。前者中位數年齡為46歲(28-62歲),後者為40歲(23-59歲)。研究分別於接種第二劑疫苗的當天、7-10天後及30天後採取受試者血液樣本,檢驗以下的抗SARS-CoV-2抗體:
Spike protein (S)-specific IgG及Receptor-binding domain (RBD)-specific IgG,採用ELISA法檢驗。
1. 以原始病毒株(2020年初分離自瑞典)進行中和抗體檢驗,於Umea大學BSL-3實驗室進行。
2. 以B.1.351 (南非beta變異株)病毒株進行中和抗體檢驗,於Karolinska學院BSL-3實驗室進行。
此外,研究也分析兩組受試者於接種疫苗後出現的反應。
■ 結果
1. S-specific IgG及RBD-specific IgG濃度
- 接種第二劑疫苗當天,兩組的S-specific IgG和RBD-specific IgG濃度相近。
- 第二劑7-10天後,AZ/Moderna組的S-specific IgG及RBD-specific IgG濃度分別為第二劑當天的115倍及125倍,AZ/AZ組的S-specific IgG及RBD-specific IgG濃度則為第二劑當天的5倍。
- 第二劑30天後,兩組S-specific IgG濃度和各自第二劑7-10天後的濃度相近。
2. 對原始病毒株的中和抗體
- 接種第二劑疫苗當天,兩組的中和抗體效價相近。
- 第二劑7-10天後,AZ/Moderna組的中和抗體效價為第二劑當天的20倍,AZ/AZ組則為第二劑當天的2倍。
- 第二劑30天後,兩組中和抗體效價約為各自第二劑7-10天後效價的1.6-1.7倍,不過增加的幅度並不顯著。
3. 對南非變異株的中和抗體
- 第二劑7-10天後,AZ/Moderna組可產生對抗南非變異株的中和抗體,但AZ/AZ組無法產生足夠對抗南非變異株的中和抗體。
在副作用方面,AZ/Moderna組較常出現發燒、頭痛、發冷及肌肉痠痛,不過若依副作用反應程度分級評估,兩組並無顯著差異。整體副作用的發生情形,也與已發表兩劑均為ChAdOx1或均為mRNA-1273的臨床試驗結果一致。
■ 結論
接種一劑ChAdOx1疫苗9-12週後,第二劑若接種mRNA-1273疫苗將能誘導出更高的抗體濃度和中和抗體效價,對南非變異株的保護力也更強。因此作者建議,針對已接種過兩劑ChAdOx1的民眾,若未來需追加第三劑疫苗時,可考慮接種mRNA疫苗(mRNA-1273)...完整轉譯文章,詳連結:http://forum.nhri.org.tw/covid19/virus/j_translate/j2679/ ( 財團法人國家衛生研究院 吳綺容醫師摘要整理)
註:此臨床試驗仍在進行中,歐洲臨牀試驗編號(EudraCT number)為2021 -000683-30。
📋 The New England Journal of Medicine - 2021-07-14
Heterologous ChAdOx1 nCoV-19 and mRNA-1273 Vaccination
■ Author:Johan Normark, Linnea Vikström, Yong-Dae Gwon, et al.
■ Link:https://www.nejm.org/doi/full/10.1056/NEJMc2110716
〈 國家衛生研究院-論壇 〉
➥ COVID-19學術資源-轉譯文章 - 2021/07/29
衛生福利部
疾病管制署 - 1922防疫達人
疾病管制署
財團法人國家衛生研究院
同時也有10000部Youtube影片,追蹤數超過2,910的網紅コバにゃんチャンネル,也在其Youtube影片中提到,...
eudract 在 台灣光鹽生物科技學苑 Facebook 的最讚貼文
【International Live Webinar Series】Strategies for Applying Clinical Trials in Europe歐洲臨床試驗申請策略與佈局
🌍此次學苑特別推出國際線上同步遠距課程,並與德國講師合作,提供學員最新的國際臨床試驗實務課程!
此次課程為系列課程,首堂為”歐洲臨床試驗申請策略與佈局”。對於想往歐洲發展、合作或與歐洲從事臨床試驗的相關公司廠商有很大的幫助!
Date:
Part 1: 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
Part 2: 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
Location:Online Webinar Training
Instructor:Anika Staack, Founder of ARC-TRAICOA / EU-QPPV
【Course Outline】
Part 1 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
A. Europe – One Union with differences
B. European Clinical Trial Directive
1.Role of national competent authorities
2.Role of ethics committees (central / local)
3.Role of investigator
4.Role of sponsor
5.Role of EMA
C. Planning clinical trials in Europe
1.Analysis of product
a.Indication
b.Patient group
2.Analysis of end points
3 .Analysis of protocol
4.Preparing feasibility
5.Choosing Key Opinion Leaders
6.Sponsor or IIT?
7.Similar studies already running?
Part 2 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
A. Applying clinical trial
1.Collecting information you need
2.Establishing study team
B. Required entry into EudraCT
C. Required approval from national HAs and ethics
D. Required fulfilment of national data protection laws
E. Considerations
1.Doing it by yourselves
2.Contracting CRO
3.Auditing
F. Upcoming issues: Site and patient recruitment, site resources, patients withdrawal, protocol amendments
G. Final presentation of study reports
Online Course Fees include 2 Webinars, 90 minutes each:
Special Price $160 USD per Person; Original Price $180 USD
(*1) Certificate of Attendance will be issued only if participants attend both part 1 & 2 webinar
(*2) Certificate of Completed Assessment will be issued only if participant pass the assessment
Register here 👉 https://forms.gle/Kj9yMVynsq7yzSzs8
Organizer:ARC-TRAICOA
Co-Organizer:Salt and Light Institute
【Target Audience】
(1.) Anyone who is interested in clinical trials in Europe
(2.) Anyone who has experience in working in clinical trials related field such as PI,PM,RA,RD,MA,DM,ST,CRA, CRC,QC,QA, etc)
【Instructor CV】
Anika Staack
Current Position:
Founder of ARC-TRAICOA
EU-Qualified Person for Pharmacovigilance (EU-QPPV)
Local German QPPV Consultant and Speaker
Previous Experience:
EU-QPPV / Stufenplanbeauftragte & Group Leader PV at Medice
Senior Drug Safety Manager at ICON
Lead Site Management Associate at PRA
Clinical Research Associate at SKM Oncology
Expertise:
Expertise Databases: European Medicine Agency EudraVigilance and xEVMPD
Quality Assurance: Audits & Inspections, SOP Writing and QA documentation, recalls and product quality
Clinical Trial Management: Feasibility, monitoring, eCRF set-up, database reconciliation, site selection, contract management, patient recruitment, study reports
Authorization process: PSMF, RMP & PSUR Writing, answering authority requests, Risk Management, overseeing product life-cycle
Education Background:
Master of Science (Biology)
Email: bioschool@biotech-edu.com Tel: (+886) 02-2545-9721 ext.18
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