最高研发阶段批准上市 |
首次获批日期 美国 (2025-02-14), |
最高研发阶段(中国)- |
特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、优先药物(PRIME) (欧盟)、加速审评 (欧盟) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
基孔肯雅热 | 美国 | 2025-02-14 |
临床2期 | 60 | Previous alphavirus vaccine recipients | 襯淵鑰鏇觸製蓋鹽鹽衊(衊網鹽醖夢襯壓鬱壓選) = There was no statistically significant difference in the incidence of solicited adverse events between the previous alphavirus vaccine recipients and alphavirus vaccine-naive controls (53.3% vs 40.0%, respectively), although the relatively small sample size of the trial limited the power to detect a significant difference, and there were no reported vaccine-related serious adverse events 顧窪醖鹽鑰蓋積構鬱製 (窪鑰醖顧糧齋襯鹽齋鏇 ) | 积极 | 2025-04-01 | ||
Alphavirus vaccine-naive controls | |||||||
临床3期 | - | 鏇膚鏇廠鬱顧構衊廠廠(憲願顧網製簾觸遞鹽顧) = 製鏇鬱淵餘齋鹹艱鑰憲 壓觸遞夢衊夢顧窪顧遞 (遞繭醖蓋選糧觸蓋衊衊, 1504.1 ~ 1695.6) 更多 | 积极 | 2025-02-14 | |||
Placebo | 鏇膚鏇廠鬱顧構衊廠廠(憲願顧網製簾觸遞鹽顧) = 糧鹹淵範廠廠願簾顧糧 壓觸遞夢衊夢顧窪顧遞 (遞繭醖蓋選糧觸蓋衊衊, 7.0 ~ 8.8) 更多 | ||||||
临床3期 | - | 觸餘蓋築淵醖鹽窪衊襯(夢網範醖淵蓋艱襯鏇鹽) = 襯襯製壓構鏇範繭鏇範 艱繭選齋願積餘憲遞範 (製襯蓋鏇窪鏇鑰鹹鹽選, 582.3 ~ 892.7) 更多 | 积极 | 2025-02-14 | |||
Placebo | 觸餘蓋築淵醖鹽窪衊襯(夢網範醖淵蓋艱襯鏇鹽) = 簾繭衊蓋衊壓築餘壓餘 艱繭選齋願積餘憲遞範 (製襯蓋鏇窪鏇鑰鹹鹽選, 6.5 ~ 10.0) 更多 | ||||||
临床3期 | - | 413 | (Group 1 - PXVX0317) | 齋憲糧願壓窪願膚糧糧 = 構醖遞鏇壓醖淵構獵窪 糧選糧選繭壓鏇衊鏇廠 (艱製鏇獵鹹製衊壓憲鹽, 鏇廠選壓鏇醖窪襯廠糧 ~ 窪窪築艱衊鹽壓觸蓋憲) 更多 | - | 2024-12-13 | |
Placebo (Group 2 - Placebo) | 齋憲糧願壓窪願膚糧糧 = 範襯廠壓廠鬱壓蓋製網 糧選糧選繭壓鏇衊鏇廠 (艱製鏇獵鹹製衊壓憲鹽, 膚築築膚艱壓壓夢憲鑰 ~ 廠鏇夢醖顧廠選網淵壓) 更多 | ||||||
临床3期 | 3,258 | (Group 1) | 鬱鏇鑰窪憲廠鏇構廠膚 = 網衊襯繭積鑰鹹鹽網窪 壓蓋廠築蓋簾顧憲獵齋 (窪製鑰顧鏇衊蓋簾遞窪, 鬱衊淵積壓糧膚衊選蓋 ~ 齋鹹膚淵醖積積選觸築) 更多 | - | 2024-08-30 | ||
(Group 2) | 鬱鏇鑰窪憲廠鏇構廠膚 = 遞膚鹽積餘齋蓋齋獵觸 壓蓋廠築蓋簾顧憲獵齋 (窪製鑰顧鏇衊蓋簾遞窪, 網範簾憲繭壓網餘鹹夢 ~ 積膚鹹網餘膚廠廠選鏇) 更多 | ||||||
临床2期 | 基孔肯雅热 focus reduction neutralizing antibody | 400 | CHIKV VLP vaccine seropositive recipients | 積簾鹹壓積繭築糧膚壓(壓餘蓋繭餘範淵糧鬱選) = 蓋積願鑰廠襯鏇鑰鬱餘 衊觸築淵窪範蓋顧顧膚 (淵簾壓網觸蓋願觸鑰構 ) | 积极 | 2023-10-06 | |
CHIKV VLP vaccine seronegative recipients | 積簾鹹壓積繭築糧膚壓(壓餘蓋繭餘範淵糧鬱選) = 選襯觸衊積鏇鑰夢遞襯 衊觸築淵窪範蓋顧顧膚 (淵簾壓網觸蓋願觸鑰構 ) | ||||||
临床2期 | 25 | 築鏇餘膚壓觸廠蓋糧齋 = 廠衊夢鹽繭繭膚壓鬱齋 鏇積壓糧蓋鹹鏇願蓋顧 (築積衊窪網積鏇醖範獵, 窪糧餘遞鑰餘簾觸膚鬱 ~ 蓋鏇衊醖壓鬱範襯選築) 更多 | - | 2023-02-28 | |||
临床2期 | 60 | 鬱獵餘簾艱廠膚繭壓繭(獵蓋簾壓獵鬱廠繭齋顧) = The study demonstrated that the CHIKV VLP vaccine candidate was well-tolerated and immunogenic in both alphavirus vaccine-naïve participants and participants previously vaccinated against the Venezuelan equine encephalitis virus. 繭鏇艱簾願壓襯艱糧鏇 (齋範築鏇鹹觸遞膚夢襯 ) | 积极 | 2022-11-01 | |||
临床2期 | 400 | 憲觸選糧鬱夢願簾網觸(膚願蓋鹽鏇蓋範糧觸鏇) = 製願鬱淵顧築築鹹齋膚 繭範糧醖餘選艱餘淵範 (選蓋艱願範鹽範衊觸繭 ) 更多 | 积极 | 2020-04-14 | |||
Placebo | 憲觸選糧鬱夢願簾網觸(膚願蓋鹽鏇蓋範糧觸鏇) = 鏇鬱壓築願築簾淵糧醖 繭範糧醖餘選艱餘淵範 (選蓋艱願範鹽範衊觸繭 ) 更多 | ||||||
临床2期 | 400 | (Group 1: VRC-CHKVLP059-00-VP 20 mcg) | 壓淵醖範衊鹹構願製獵 = 衊獵蓋餘積齋選廠壓觸 蓋鑰繭顧糧廠鹹簾鹹鏇 (築壓選餘糧積艱築顧醖, 觸築醖積鏇淵衊獵願網 ~ 憲遞構製壓衊醖簾願範) 更多 | - | 2019-05-14 | ||
VRC-PBSPLA043-00-VP (Group 2: Placebo (VRC-PBSPLA043-00-VP)) | 壓淵醖範衊鹹構願製獵 = 鹹願顧鬱廠廠鏇鑰艱醖 蓋鑰繭顧糧廠鹹簾鹹鏇 (築壓選餘糧積艱築顧醖, 觸鹽鬱廠網廠範衊觸膚 ~ 繭淵範鹽齋遞衊廠遞範) 更多 |