- 疫苗抗原是基因重組棘蛋白S-2P，技術來自於美國NIH，經過基因修飾的S-2P可維持在融合前三聚體構型（trimeric pre-fusion form），使抗原更加穩定。
- 疫苗佐劑採用美國Dynavax藥廠的CpG 1018佐劑與鋁鹽佐劑
最新進度
- 從2020年底高端新冠肺炎疫苗展開擴大第二期臨床試驗，在3個月內完成3,015名受試者收案。
- 2021/6/10 由獨立科學專家組成的IDMC獨立數據監測委員會進行期間分析解盲。數據顯示，高端新冠肺炎疫苗安全性與耐受性良好，所有受試者未出現疫苗相關嚴重不良反應。
- 2021/7/19 取得台灣專案製造核准（EUA）。
- 2021/10/27 獲選為WHO團結試驗疫苗，於哥倫比亞、馬利及菲律賓三個國家，展開全球萬人規模、多國多中心、多疫苗、適應性、共享安慰劑的第三期臨床試驗。
- 2022/2/14 取得巴拉圭專案製造核准（EUA）。
新冠肺炎疫苗
藥物開發/臨床前
第一期臨床試驗
第二期臨床試驗
第三期臨床試驗
上市銷售
公開發表文獻
Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in adolescents in Taiwan: A double-blind, randomized, placebo-controlled phase 2 trial
15 March 2022|MedRxiv
READ MOREThe reactogenicity and immunogenicity of a booster dose after the second dose of a protein subunit vaccine MVC-COV1901: An extension to an open-label, dose-escalation, and non-randomized phase 1 study
4 January 2022|MedRxiv
READ MOREEvaluating the Neutralizing Ability of a CpG-Adjuvanted S-2P Subunit Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Variants of Concern
5 November 2021|Clinical Infectious Diseases
READ MORESafety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan
13 October 2021|The Lancet Respiratory Medicine
READ MOREProtection of Hamsters Challenged with SARS-1 CoV-2 Variants of Concern by Two Doses of MVC-COV1901 Vaccine Followed by a Single Dose of Beta Variant Version of MVC-COV1901
29 September 2021|bioRxiv
READ MORESafety and Immunogenicity of CpG 1018 and Aluminium Hydroxide-Adjuvanted SARS-CoV-2 S-2P Protein Vaccine MVC-COV1901: A Large-Scale Double-Blinded, Randomised, Placebo-Controlled Phase 2 Trial
8 August 2021|MedRxiv
READ MORESafety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVCCOV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study
25 June 2021|EClinicalMedicine
READ MORECpG-adjuvanted stable prefusion SARS-CoV-2 spike protein protected hamsters from SARS-CoV-2 challenge
22 April 2021|Scientific Reports
READ MOREEvaluating the neutralizing ability of a CpG-adjuvanted S-2P subunit vaccine against SARS-CoV-2 Variants of Concern
22 March 2021|MedRxiv
READ MOREDevelopment of CpG-adjuvanted stable prefusion SARS-CoV-2 spike antigen as a subunit vaccine against COVID-19
18 November 2020|Scientific Reports
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