Re: [爆卦] 高端疫苗一期數據公佈

※ 引述《seanww (seanmm)》之銘言：
: https://i.imgur.com/1QNez3u.jpg

: 目前因為還沒有新聞出來，所以分類用爆卦～
: 附上原報告連結：https://www.medrxiv.org/content/10.1101/2021.03.31.21254668v1: 報告內容為英文，有興趣的自己翻譯，小弟不才稍微擷取一些重點，主要是在打完第二劑: 之後體內抗體提升
: https://i.imgur.com/Q7N5aja.jpg
: https://i.imgur.com/qicVHzd.jpg
: 疫苗屬於安全也沒有明顯過敏反應
: https://i.imgur.com/zTSngTP.jpg
: 同時在第43天測得數據高峰
: 大略翻譯一下，睡前已昏頭，若有錯誤還請見諒！
: 心得：二期收案完成還超標，一期的數據也出來了，根據衛福部之前的記者會說的簽約標: 準，看來阿中該宣布簽約了？希望台灣能早點完成疫苗施打重開國門！
Design This is a phase 1, dose-escalation open-label trial to evaluate the safety and immunogenicity of MVC-COV1901, a recombinant stabilized prefusion SARS-CoV-2 spike (S-2P) protein vaccine with adjuvant of aluminum hydroxide and CpG 1018.
第一期試驗之設計採開放式、劑量增量法，以量測本疫苗產品(MVC-COV1901)之免疫力與安全性。
本疫苗產品(MVC-COV1901)為採氫氧化鋁和CpG 1018為佐劑，重組穩定預熔合SARS-CoV-2病毒突刺蛋白疫苗。

Methods We enrolled 45 healthy adults from 20 to 49 years of age to be administered with two vaccinations of MVC-COV1901 in a low dose (LD), middle dose (MD), and high dose (HD) of spike protein at 28 days apart. There were 15 participants in each dose group, and all of them were followed up for 28 days after the second vaccination at the time of interim analysis.
方法上我們募集45位健康成年，分佈於20歲至49歲，低劑量(15名)、中劑量(15名)、高劑量(15名)，間隔28天接種2劑本病毒突刺蛋白疫苗產品(MVC-COV1901)。第2劑後追縱28天進行分析。

Adverse events (AEs) and laboratory data were recorded for safety evaluation.針對其不良反應及實驗數據，以進行安全性評估。

Blood samples were collected for wild-type SARS-CoV-2 and pseudovirus neutralization assays as well as SARS-CoV-2 spike-specific immunoglobulin G (IgG) at various times.
血液樣本在不同時期經採集後做為野生種新冠病毒(wild-type SARS-CoV-2)與假病毒中和抗體(pseudovirus neutralization)試驗，是否產生新冠病毒(SARS-CoV-2)的特殊突刺蛋白之IgG抗體。

Overall, the study duration will be 7 months.
該試驗共進行7個月

Results Solicited events were mostly mild and similar in the participants of all three dose groups.
自各組別受試者中觀察到的反應皆是輕微且類似。

No subject experienced fever.
沒有任何受試者發燒

There were no serious nor adverse events of special interest at the time point of this interim report.
期中報告期間並無發現任何值得觀注之嚴重與不良反應

After the second vaccination, the SARS-CoV-2 spike specific IgG titers increased with peak geometric mean titers at 7178.245 (LD), 7746.086 (MD), and 11220.58 (HD), respectively.
施打完二劑後，新冠病毒特殊突刺免疫球蛋白IgG抗體滴度之幾何平均峰值分別達到7178.245 (低劑量組), 7746.086 (中劑量組), and 11220.58 (高劑量組)

Serum neutralizing activity was detected by two methods in all participants of MD and HD groups, with geometric mean values generally comparable to those of a panel of control convalescent serum specimens.
對中劑量與高劑量組進行血清中和活性試驗，其結果之幾何平均值同等於控制組(新冠肺炎恢期病患)所得血清樣本

All of the participants in the MD and HD groups were seroconverted after the second vaccination.
中劑量與高劑量組施打二劑後進行血清培養

Conclusions The MVC-COV1901 vaccine is safe and elicits remarkable immune responses especially in the MD and HD groups.
實驗結果說明本病苗產品(MVC-COV1901)為安全有效，尤其中劑量與高劑量組明顯可以喚起免疫反應

Szu-Min Hsieh, Shan-Chwen Chang, Wang-Da Liu, Yu-Shan Huang declared that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper;
Szu-Min Hsieh, Shan-Chwen Chang, Wang-Da Liu, Yu-Shan Huang以上成員之間無競爭財務利益或競爭關係
如有關係可能會影響本文報導

Yi-Jiun Lin, Erh-Fang Hsieh, Wei-Cheng Lian, Charles Chen, I-Chen Tai reported grants from Taiwan Centers for Disease Control, Ministry of Health and Welfare, during the conduct of the study.
Yi-Jiun Lin, Erh-Fang Hsieh, Wei-Cheng Lian, Charles Chen, I-Chen Tai宣告曾接受台灣衛福部疾管署捐款

In addition, Yi-Jiun Lin and Charles Chen have a patent US63/040,696 pending.Yi-Jiun Lin and Charles Chen正申請專利US63/040,696

Clinical Trial
NCT04487210
臨床試驗字號NCT04487210

Funding Statement
資金說明

Taiwan Centers for Disease Control, Ministry of Health and Welfare provided grant funding for this study, but does not necessarily stand by any commentary made in this paper.
台灣之衛服部疾管署提供研究經費，但獨立於本文之論述立場

Medigen Vaccine Biologics Corp. was the study sponsor and manufacturer of the investigational vaccine, and co-designed the trial, provided the study product, and coordinated interactions with regulatory authorities.
Medigen Vaccine Biologics Corp(高端疫苗)為本研究之贊助商與本新疫苗之生產廠商，並提供試驗之設計，提供研究之產品，並負責與當局之協調與往來

The sponsors used contract clinical research organization to oversee clinical site operations.
主辦單位採受託研究機構模式進行監督臨床醫院運作

Data were collected by the clinical site research staff, managed by a contract research organization data management team, monitored by a contract research organization, and overseen by the sponsor and an independent data and safety monitoring board.
資料採集者為臨床醫院員工，由受託研究機構資料維護團隊管理，並由受託研究機構監督。由贊助者與獨立數據監測委員會監督

The interim analysis was performed by the contract research organization.
期中試驗委由受託研究機構揭露

Data interpretation, manuscript preparation were performed by the authors and the decision to submit the manuscript for publication was made by the authors.
資料呈現、手稿已依作者群決議出版

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