※ 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