[問卦] 哪裡有寫到疫苗的有效性??
以下資料來自台灣藥物臨床試驗資訊網
看的出來,國產疫苗的二期臨床主要是觀察有效性、安全性還有免疫生成性
哪裡有寫到疫苗的有效性??
https://www1.cde.org.tw/ct_taiwan/
試驗藥品名稱 / 成分 :MVC-COV1901 vaccine (暫定) / SARS-CoV-2 S-2P棘蛋白
試驗計畫標題(名稱):第二期、前瞻性、隨機分配、雙盲、劑量比較、多中心試驗,
以評估SARS-CoV-2候選疫苗MVC-COV1901 對老年人之安全性、
耐受性及免疫生成性
試驗申請者:高端疫苗生物製劑股份有限公司
試驗目的:評估大致上健康或既有醫療狀況穩定的65 歲以上受試者,施打高劑量 MVC
COV1901 疫苗相較於中劑量 MVC COV1901 安全性和免疫生成性。
試驗藥品名稱 / 成分 : MVC-COV1901 vaccine (暫定) / SARS-CoV-2 S-2P棘蛋白
試驗計畫標題(名稱):一項第二期、前瞻性、雙盲、多中心、多地區試驗,以評估
SARS CoV 2候選疫苗 MVC COV1901 之安全性、耐受性及免
疫生成性 。
試驗申請者:高端疫苗生物製劑股份有限公司
試驗目的:
主要目的:
評估受試者施打兩劑 MVC COV1901 疫苗後之安全性 、 耐受性 及免疫生成性 。
至第二劑後 28 天
次要目的:
評估 受試者整個試驗期間之安全性、批次間一致性及免疫生成性 。
如果是在ClinicalTrial.gov上查詢的話,這兩個試驗分別為:
A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly Adults
Study Description
Brief Summary:
The purpose of this study is to assess the safety and immunogenicity of
MVC-COV1901 vaccine in two different dose forms in participants who are
generally healthy or with stable pre-existing health conditions.
Outcome Measures
Primary Outcome Measures :
Incidence of Adverse Events(AEs) [Safety and Tolerability] [ Time Frame: Day
1 to 28 days after the second vaccination ]
To evaluate the incidence of Adverse Events(AEs) of MVC-COV1901 from Visit 2
(Day 1) to Visit 6 (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)
Immunogenicity of MVC-COV1901 [ Time Frame: Day 1 to 28 days after the secondvaccination ]
To evaluate the immunogenicity of High-dose MVC-COV1901, as compared to
Mid-dose MVC-COV1901, in terms of neutralizing antibody titers.
Secondary Outcome Measures :
Incidence of Adverse Events(AEs) [Safety and Tolerability] [ Time Frame: Day
1 to 180 days after the second vaccination ]
To evaluate the Incidence of Adverse Events(AEs) of MVC-COV1901 over the
study period in terms of the number and percentage of participants with the
occurrence of:
>= Grade 3 AE AE of Special Interest (AESI) Vaccine-Associated Enhanced
Disease(VAED) Serious adverse events (SAEs)
Immunogenicity of MVC-COV1901 [ Time Frame: Day 1 to 180 days after the
second vaccination ]
The antigen-specific immunoglobulin titers and neutralizing antibody titers
at Visit 4 (28 days after the first dose of study intervention), Visit 6 (28
days after the second dose of study intervention), Visit 7 (90 days after thesecond dose of study intervention) and Visit 8 (180 days after the second
dose of study intervention) in terms of antigen-specific immunoglobulin
titers and neutralizing antibody titers
另一個太長了就貼連結自己點進去看
--
據說「免疫生成性」與保護力有高相關
neutralizing antibody titers
有效性就在你沒貼的那段 Other Outcome M
easures:
Incidence of confirmed COVID-19 cases
不過以台灣之前那麼少確診數,我猜這有
效性很難達到顯著差異,二期最終恐怕還是
以疫苗能打出抗體當全民施打的依據
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