Re: [新聞] 5月底請辭國產疫苗審查委員陳培哲：原因就是蔡總統

看板Gossiping作者Cetuximab (單株)時間3年前 (2021/06/07 21:23)推噓10(10推 0噓 13→)

留言23則, 18人參與討論串13/16 (看更多)

※ 引述《sincere77 (台灣會更好)》之銘言： : 1.媒體來源: : 自由時報 : 2.記者署名: : 林惠琴 : 3.完整新聞標題: : 5月底請辭國產疫苗審查委員陳培哲：原因就是蔡總統 (內文恕刪) 大家別太緊張 PJ也沒說他審的是高端還是聯亞或是兩個都審先來看看這兩家的臨床二期試驗資訊聯亞 https://reurl.cc/rg1pRr ClinicalTrials.gov Identifier: NCT04773067 Study Type : Interventional (Clinical Trial) Estimated Enrollment : 3850 participants Actual Study Start Date : January 30, 2021 Estimated Primary Completion Date : June 30, 2021 Estimated Study Completion Date : June 30, 2022 Primary Outcome Measures 1. Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody [ Time Frame: Day 57 ] Evaluation of immunogenicity 2. Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 57 ] Evaluation of immunogenicity 3. Safety evaluation [ Time Frame: Day 1 to Day 197 ] Local reactions and systemic events for up to 7 days following each dose Unsolicited adverse events from Day 1 to Day 57 MAAEs, SAEs, AESIs and ADEs from Day 1 to Day 197 高端 https://reurl.cc/xGEdQZ ClinicalTrials.gov Identifier: NCT04695652 Study Type : Interventional (Clinical Trial) Estimated Enrollment : 3700 participants Actual Study Start Date : December 30, 2020 Estimated Primary Completion Date : June 2021 Estimated Study Completion Date : June 2022 Primary Outcome Measures : 1. Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901) [ Time Frame: Day 1 to 28 days after second vaccination ] To evaluate the safety and tolerability of MVC-COV1901 from Visit 2 (Day 1) to Visit 7 (28 days after the second dose of study intervention) in terms of the number and percentage of participants with the occurrence of: Solicited local AEs (up to 7 days after each dose of study intervention) Solicited systemic AEs (up to 7 days after each dose of study intervention) Unsolicited AEs (up to 28 days after each dose of study intervention) AE of Special Interest (AESI) Vaccine-Associated Enhanced Disease(VAED) Serious adverse events (SAEs) 2. Immunogenicity of MVC-COV1901 [ Time Frame: Day 1 to 28 days after second vaccination ] To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers 簡單來說這兩家的臨床二期的Primary Outcome都有說要看Immunogenicity 也都是要看施打完疫苗的neutralizaing antibody titers 然後疫苗有沒有產生免疫效果在這試驗階段就要看這個neutralizaing antibody的表現是否很棒棒去統計受試者打完過28天之後體內所產生出來的中和抗體濃度是否仍能有效阻礙(中和)病毒感染細胞然後計算統計上是否達到顯著差異以及有效群體數量(%)等至於中和抗體要到多少程度可以有效阻止SARS-CoV-2感染細胞並且可以用來作為橋接試驗的標準濃度國外專家會議尚未有明確定論 (也就是俗稱的：窩不知道) 但是也因為還沒有明確定論就決定要用中和抗體濃度來當效力標準那titer是要用 (1：4) (1：8) (1：16) (1：32)還是 (1：64)當標準呢 https://imgur.com/a/pVjIQqt.jpg