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GlaxoSmithKline / Medicago adjuvant cog tsob ntoo los ntawm cov tshuaj tiv thaiv COVID-19 pib theem 2/3 soj ntsuam sim!

[Nov 20, 2020]

Tsis ntev los no, GlaxoSmithKline (GSK) thiab Medicago sib koom ua ke tshaj tawm Kev Ua Phem Ntu 2/3 kev sim tshuaj txhawm rau tshuaj xyuas qhov ua tau zoo, kev nyab xeeb thiab kev tiv thaiv kab mob ntawm nws cov nroj tsuag los ntawm QHID-19 tshuaj tiv thaiv tus neeg sib tw CoVLP. Raws li cov txiaj ntsig tau zoo ntawm Theem 1 kev sim tshuaj saib mob, Medicago tau txiav txim siab siv GSK' s kev kis rau ntau tus kabmob rau ntu 2/3 kev soj ntsuam kuaj mob.


Qhov tshuaj tiv thaiv Coronavirus-Zoo li Particle COVID-19 Tus Neeg Pov Thaiv Tshuaj Tiv Thaiv (CoVLP) yog cov tshuaj tiv thaiv tso tshuaj ntsuab THID-19 cov tshuaj tiv thaiv ua rau muaj sib xyaw ua ke (S) glycoprotein qhia tias yog cov zoo li tus kabmob (VLPs).

Theem 2/3 qhov kev sim kuaj mob no siv ntau qhov kev tsim qauv kom paub tseeb tias xaiv tau tus qauv CoVLP thiab cov tshuaj tiv thaiv kab mob (3.75μg CoVLP sib xyaw nrog GSK kis tus kabmob kis, 2 txhaj tshuaj tiv thaiv nyob rau ntawm 21 hnub) nyob rau 18-64 xyoo nws muaj immunogenicity lees txais tau thiab kev nyab xeeb rau cov neeg laus thiab cov laus hnub nyoog 65 xyoo thiab laus dua.


Nathalie Landry, Medicago' tus thawj coj ntawm thawj coj ntawm kev tshawb fawb thiab kev kho mob, tau hais tias:" Peb Theem 1 cov qhab nia rau cov neeg siv tshuaj tiv thaiv kab mob tau txais kev txhawb nqa zoo thiab txhawb nqa kev soj ntsuam ntxiv."


Thomas Breuer, Tus Thawj Saib Xyuas Kev Noj Qab Haus Huv ntawm GSK, tau hais tias:" Qhov no yog thawj koob tshuaj tiv thaiv ntau yam ntawm GlaxoSmithKline COVID-19 cov neeg txhaj tshuaj tiv thaiv pib pib Theem 2/3. Nws tseem yog ib ruam tshiab rau peb kev koom tes rau hauv ntiaj teb no tiv thaiv kev kis thoob qhov txhia chaw. Ib qeb tseem ceeb. Peb zoo siab nrog cov lus cog tseg Theem 1 uas tau tshwm sim ntawm kev sib xyaw ntawm Medicago's COVID-19 cov tshuaj tiv thaiv kev sib kis thiab GSK qhov kis tau kis mus rau lwm qhov ntxiv. GlaxoSmithKline' s cov neeg ua haujlwm tau muab pov thawj kom txuag tau cov koob tshuaj thiab cov tshuaj tiv thaiv kab mob siab, yog li peb ntseeg siab koom tes nrog Medicago muab cov tshuaj tiv thaiv zoo nrog rau qhov muaj kev nyab xeeb zoo."


Ntu 2 ntawm Ntu 2/3 kev sim yog kev soj ntsuam randomized, saib-saib tsis pom kev, tshuaj xyuas cov chaw uas tsim los soj ntsuam qhov xav tau qhov tshuaj tiv thaiv COVID-19 cog los ntawm cov tshuaj tiv thaiv rau cov muaj hnub nyoog 18 xyoo thiab laus dua Kev Nyab Xeeb thiab cov tshuaj tiv thaiv kab mob hauv no ib feem yuav ua rau ntau qhov chaw hauv Canada thiab Asmeskas, ntawm cov neeg laus noj qab haus huv (18-64 xyoo) thiab cov laus (tshaj 65 xyoo). Ntau tshaj 300 yam nyob rau txhua pab pawg hnub nyoog yuav tau txais koob tshuaj tiv thaiv CoVLP sib tw ntawm cov piv txwv ntawm 5: 1: cov placebo, thiab cov neeg laus (65-74 xyoo thiab ≥75 xyoo) yuav raug muab teev tseg 2: 1. Txhua yam kev kawm yuav raug taug qab rau 12 lub hlis tom qab txhaj tshuaj tiv thaiv zaum kawg los soj ntsuam qhov kev nyab xeeb thiab kev ua kom tau zoo ntawm cov tshuaj tiv thaiv kab mob rau cov neeg sib tw txhaj tshuaj.


Lub Ntu 3 ntawm kev sim yuav pib ua ntej xaus rau xyoo 2020, siv ib qho kev tshwm sim uas tau tsav, ua kom tsis muaj txiaj ntsig, muaj kev saib pom-dig muag, tswj qhov chaw, thiab yuav siv ntau tshaj 30,000 pawg hauv North America, Latin America thiab / lossis Teb chaws Europe. Txheeb xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm CoVLP npaj piv nrog cov placebo hauv tib qho lossis dav dua.


Medicago yog lub tuam txhab kev lag luam biopharmaceutical chaw nyob hauv Quebec, Canada, thiab yog tus ua haujlwm pib kho cov ntoo los kho. Lub tuam txhab tau tsim hauv xyoo 1999 thiab ntseeg khov kho tias txoj hauv kev tshiab thiab kev tshawb fawb nruj yuav coj cov kev daws teeb meem tshiab rau kev kho mob.


Lub tuam txhab' s lub hom phiaj yog los teb sai sai rau cov teeb meem kev noj qab haus huv thoob ntiaj teb thiab txhim kho cov txiaj ntsig kev noj qab haus huv thoob ntiaj teb los ntawm kev siv cov kev cog ntoo tshiab. Tam sim no, lub tuam txhab tau cog lus rau kev kho mob los tiv thaiv cov kab mob kev phom sij rau lub ntiaj teb.


Yav dhau los, Medicago twb tau qhia tawm lub tuam txhab' s thawj cov lus teb hauv kev muaj peev xwm hauv kev sib kis. Hauv xyoo 2009, lub tuam txhab tau tsim cov neeg tshawb fawb txog qib tshuaj tiv thaiv tus mob H1N1 tsuas yog 19 hnub. Xyoo 2012, Medicago tsim tawm 10 lab tus neeg txhaj tshuaj tiv thaiv kab mob npaws rau lub Chaw Haujlwm Tiv Thaiv Kev Tshawb Fawb Kev Nyab Xeeb (DARPA) nyob hauv Asmeskas Tsav Xwm Saib Xyuas Kev Tiv Thaiv hauv ib lub hlis. Hauv xyoo 2015, Medicago tseem tau ua pov thawj hauv lub hauv paus ntsiab lus tias nws tuaj yeem tsim cov dej cawv sai sai rau cov kab mob monoclonal tiv thaiv kab mob Ebola tiv thaiv rau Biomedical Advanced Research thiab Development Agency (BARDA) nyob hauv Asmeskas Chav Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Tib Neeg.