Rhuav Xov Xwm Thoob Ntiaj Teb Fab Kis Rhuav Xov Xwm Xov xwm kho mob Cov neeg trending Tam sim no

Kev txhaj tshuaj tiv thaiv COVID-19 tshiab hauv kev tsim: Tsis muaj kev phom sij!

sau los ntawm Juergen T Steinmetz

Valneva SE os tab tom tsim los ntawm Dynavax Technologies Corporation Nws yog lub tuam txhab ua lag luam biopharmaceutical uas tau tsom mus rau kev siv lub zog ntawm lub cev los ntawm lub cev thiab hloov kho lub cev tiv thaiv kab mob los ntawm Toll-like Receptor (TLR) kev txhawb siab. Dynavax txhim kho, thiab ua lag luam tshuaj tiv thaiv tshiab.

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  • Valneva SE (Nasdaq: VALN; E.uronext Paris: VLA), lub tuam txhab tshuaj tiv thaiv tshwj xeeb, hnub no tshaj tawm cov txiaj ntsig tau zoo los ntawm Phase 3 piv txwv kev sim Cov-Sib piv ntawm nws qhov tsis ua haujlwm, txuas ntxiv tiv thaiv COVID-19 tus neeg sib tw, VLA2001.
  • Qhov tseem ceeb Phase 3, Cov-Sib Piv sib tw tau xaiv tag nrho ntawm 4,012 tus neeg koom nrog hnub nyoog 18 xyoo thiab laus dua hla 26 qhov chaw sim hauv tebchaws Askiv. Qhov kev sim tau ntsib nws qhov kev sib tw thawj qhov kawg: VLA2001 qhia tau zoo tshaj li tiv thaiv AZD1222 (ChAdOx1-S), hais txog geometric mean titer rau neutralization antibodies (GMT piv = 1.39, p <0.0001), (VLA2001 GMT 803.5 (95% CI: 748.48) , 862.59)), (AZD1222 (ChAdOx1-S) GMT 576.6 (95% CI 543.6, 611.7)), ntxiv rau qhov tsis muaj qhov tsis zoo raws li cov kev hloov pauv hloov pauv (SCR siab dua 95% hauv ob pawg kho mob) ntawm ob lub lis piam tom qab kev txhaj tshuaj thib ob (piv txwv li Hnub 43) rau cov neeg laus hnub nyoog 30 xyoo thiab laus dua.
  • T-cell cov lus teb tshuaj xyuas hauv cov pawg koom nrog pom tias VLA2001 ua rau muaj qhov dav dav antigen-specific IFN-gamma ua T-cells reactive tawm tsam S- (74.3%), N- (45.9%) thiab M- (20.3%) protein ntau.

VLA2001 feem ntau tau txais kev pom zoo. Cov ntaub ntawv tiv taus ntawm VLA2001 tau muaj txiaj ntsig zoo dua piv rau cov tshuaj tiv thaiv sib piv nquag. Cov neeg koom nrog 30 xyoo thiab laus tshaj qhia txog qhov xwm txheej tsis zoo txog li xya hnub tom qab txhaj tshuaj tiv thaiv kab mob, ob qho tib si hais txog kev txhaj tshuaj ntawm qhov chaw txhaj tshuaj (73.2% VLA2001 piv rau 91.1% AZD1222 (ChAdOx1-S), p <0.0001) thiab cov tshuaj tiv thaiv kab mob (70.2%) VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001).

Tsis tau hais qhia txog kev kho mob ntsig txog cov xwm txheej tsis zoo (SAE). Tsawg dua 1% tshaj tawm qhov xwm txheej tsis zoo ntawm kev txaus siab tshwj xeeb hauv ob pawg kho mob. Cov neeg koom nrog pab pawg hnub nyoog qis dua nrog txhaj VLA2001 qhia txog kev nyab xeeb tag nrho piv rau pawg hnub nyoog laus dua.

Qhov tshwm sim ntawm COVID-19 cov xwm txheej (tshawb pom qhov kawg) zoo ib yam ntawm pab pawg kho mob. Qhov tsis ua tiav ntawm txhua qhov xwm txheej COVID-19 hnyav yuav qhia tau tias ob koob tshuaj tiv thaiv uas siv hauv txoj kev tshawb no tiv thaiv COVID-19 hnyav uas tshwm sim los ntawm kev hloov pauv (feem ntau yog Delta).

Adas Finn, Xibfwb ntawm Paediatrics, University of Bristol, Tus Thawj Saib Xyuas Kev Tshawb Fawb, tau hais tias: "Qib qis ntawm cov tshuaj tiv thaiv kab mob thiab cov tshuaj tiv thaiv kab mob siab ua haujlwm tau zoo nrog rau cov lus teb T-cell pom nrog rau qhov kev tiv thaiv kab mob tiv thaiv kab mob tiv thaiv kab mob no yog ob qho zoo kawg thiab txhawb siab heev. Nov yog cov txheej txheem ib txwm muaj ntau dua rau kev tsim tshuaj tiv thaiv ntau dua li cov tshuaj tiv thaiv tam sim no tau siv hauv tebchaws Askiv, Europe, thiab North America thiab cov txiaj ntsig no qhia tias tus neeg siv tshuaj tiv thaiv kab mob no tab tom ua lub luag haujlwm tseem ceeb hauv kev kov yeej kev sib kis. "

Thomas Lingelbach, Tus Thawj Coj Thawj Coj ntawm Valneva, hais tias: "Cov txiaj ntsig no tau lees paub qhov zoo feem ntau cuam tshuam nrog kev tiv thaiv kab mob tiv thaiv kab mob tag nrho. Peb tau cog lus tias yuav coj peb cov neeg sib txawv tshuaj tiv thaiv kab mob mus rau daim ntawv tso cai kom sai li sai tau thiab txuas ntxiv ntseeg tias peb yuav tuaj yeem pab txhawb nqa tseem ceeb rau kev tawm tsam thoob ntiaj teb tiv thaiv COVID-19 muaj thoob qhov txhia chaw. Peb mob siab los tawm tswv yim txog kev txhaj tshuaj tiv thaiv lwm tus rau cov neeg uas tseem tsis tau txhaj tshuaj tiv thaiv. "

Juan Carlos Jaramillo, MD, Tus Thawj Saib Xyuas Kev Kho Mob ntawm Valneva, tau hais tawm: "Kuv xav ua tsaug rau cov neeg tshawb nrhiav kev sim nrog rau txhua tus neeg koom nrog sim thiab koom tes nrog, tshwj xeeb yog Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv Hauv Tebchaws thiab pab pawg kho mob hauv NHS Cov Chaw Tshawb Fawb nrog rau Public Health England. Qhov txiaj ntsig no qhia pom tus nqi ntawm kev koom tes uas peb tau pib thaum lub Cuaj Hli 2020 thiab peb tsis tuaj yeem ua tiav qhov tseem ceeb no yam tsis muaj lawv. Peb yuav txuas ntxiv ua haujlwm ze nrog MHRA kom ua tiav peb cov ntawv xa rau kev pom zoo. "

Valneva pib dov xa rau kev pom zoo thawj zaug nrog UK Cov Tshuaj thiab Cov Khoom Kho Mob Cov Cai Tswj Xyuas Lub Koom Haum (MHRA) thiab tab tom npaj pib ua cov ntawv xa rau kev pom zoo raws li European Lub Chaw Haujlwm Tshuaj. Qhov kev tshuaj xyuas zaum kawg xav tau los ntawm MHRA txhawm rau txheeb xyuas qhov ncaj ncees ntawm VLA2001-301 cov ntaub ntawv tseem muaj txuas ntxiv thiab yog qhov yuav tsum tau ua ua ntej xa zaum kawg ntawm daim ntawv qhia tshuaj kho mob.

Raws li ib feem ntawm cov phiaj xwm txhim kho khoom lag luam, Valneva tau ua tiav kev xaiv neeg 306 tus neeg tuaj yeem pab dawb hnub nyoog 56 xyoos thiab laus dua hauv New Zealand rau hauv nws qhov VLA2001-304 kev sim thiab cia siab tias yuav sau cov ntaub ntawv thaum ntxov 2022. Valneva kuj tseem tau tshaj tawm txog kev pib txais cov tub ntxhais hluas los ua expansion of Cov-Compare trial[2].

Lub Tuam Txhab tab tom npaj rau kev sim rau menyuam yaus (hnub nyoog 5-12 xyoos) thiab Valneva txhawb nqa kev sim tshuaj ntsuam xyuas VLA2001 qhov kev txhawb nqa rau cov neeg xav tau kev txhawb nqa.

Txog Phase 3 Kev Sib Koom Cov-Sib Piv (VLA2001-301)
Cov-Sib Piv (VLA2001-301) yog qhov kev xaiv, tus neeg soj ntsuam-dig muag, tswj, sib piv kev tiv thaiv kab mob hauv 4,012 tus neeg laus thiab 660 tus hluas. Co-Primary immunogenicity endpoints yog qhov zoo tshaj ntawm GMT piv ntawm VLA2001 piv rau AZD1222 (ChAdOx1-S) ntxiv rau qhov tsis zoo ntawm cov kev sib tw seroconversion ntawm nruab nrab cov tshuaj tiv thaiv nyob rau hauv ob-koob tshuaj tiv thaiv lub sijhawm plaub lub lis piam sib nrug, ntsuas ntawm ob lub lis piam tom qab kev txhaj tshuaj thib ob (piv txwv li Hnub 43) rau cov neeg laus hnub nyoog 30 xyoo thiab laus dua. Nws kuj tseem tshuaj xyuas kev nyab xeeb thiab tiv taus VLA2001 ntawm ob lub lis piam tom qab txhaj tshuaj thib ob rau cov neeg laus thiab cov hluas thaum muaj hnub nyoog 12 xyoos thiab laus dua. Kev sim raug sim ntawm 26 qhov chaw thoob tebchaws Askiv 2,972 tus neeg koom nrog hnub nyoog 30 xyoos thiab laus dua tau raug xaiv nyob rau hauv 2: 1 piv kom tau txais ob koob tshuaj txhaj ntawm VLA2001 (n = 1,977) lossis AZD1222 (ChAdOx1-S) (n = 995) ntawm qib tshuaj pom zoo, 28 hnub sib nrug, Hnub 1 thiab 29. Rau kev tshuaj xyuas kev tiv thaiv kab mob, kuaj los ntawm 990 tus neeg koom (492 txhaj tshuaj tiv thaiv kab mob VLA2001, 498 txhaj tshuaj nrog AZD1222 (ChAdOx1-S)) uas kuaj sero-negative rau SARS- CoV-2 ntawm kev tshuaj ntsuam tau tshuaj xyuas. 1,040 tus neeg koom nrog uas muaj hnub nyoog qis dua 30 xyoo tau raug xaiv los ua pab pawg uas tsis raug xaiv thiab tau txais VLA2001 28 hnub sib nrug. Cov ntaub ntawv nyab xeeb ntawm cov neeg koom nrog hnub nyoog 18-29 xyoos tau tshuaj xyuas ua ke nrog cov neeg laus hnub nyoog 30 xyoos thiab tshaj saud. Tsis ntev los no, kev sim tau pib sau npe thawj tus tub ntxhais hluas koom nrog.

Txog VLA2001
VLA2001 tam sim no tsuas yog tag nrho tus kab mob, tsis ua haujlwm, ntxiv rau kev txhaj tshuaj tiv thaiv COVID-19 hauv kev sim tshuaj hauv Europe. Nws yog npaj rau kev txhaj tshuaj tiv thaiv kab mob rau cov neeg muaj kev pheej hmoo tiv thaiv kev thauj mus los thiab cov tsos mob nrog COVID-19 thaum muaj kev kis thoob qhov txhia chaw thiab muaj peev xwm tom qab rau kev txhaj tshuaj tas mus li suav nrog hais txog qhov hloov pauv tshiab. VLA2001 kuj tseem tuaj yeem tsim nyog rau kev txhawb nqa, raws li kev txhaj tshuaj tiv thaiv kab mob ntxiv tau pom tias ua haujlwm tau zoo nrog rau tag nrho cov tshuaj tiv thaiv kab mob tsis ua haujlwm. VLA2001 tau tsim tawm ntawm Valneva tau tsim Vero-cell platform, txhawb kev tsim khoom thev naus laus zis rau Valneva daim ntawv tso cai tshuaj tiv thaiv kab mob Japanese encephalitis, IXIARO®. VLA2001 suav nrog tag nrho cov kab mob tsis ua haujlwm ntawm SARS-CoV-2 nrog qib siab S-protein sib xyaw, ua ke nrog ob qhov txuas ntxiv, alum thiab CpG 1018. Qhov kev sib xyaw ua ke no tau ua kom muaj qib tshuaj tiv thaiv ntau dua nyob rau hauv kev sim ua ntej ntau dua li alum-tsuas yog tsim thiab qhia kev hloov pauv ntawm kev tiv thaiv kev tiv thaiv kab mob rau Th1. CpG 1018 txuas ntxiv, muab los ntawm Dynavax Technologies Corporation (Nasdaq: DVAX), yog ib feem ntawm US FDA- thiab EMA pom zoo HEPLISAV-B®  tshuaj tiv thaiv Cov txheej txheem tsim khoom rau VLA2001, uas twb tau nce qib mus rau qhov kev lag luam zaum kawg, suav nrog tshuaj tsis ua haujlwm los khaws cia cov qauv ib txwm ntawm S-protein. VLA2001 yuav tsum ua kom tau raws li cov qauv kev cai txias txias (2 degrees txog 8 degrees Celsius).

Txog Valneva SE
Valneva yog lub tuam txhab tshuaj tiv thaiv tshwj xeeb tsom mus rau kev txhim kho thiab kev lag luam ntawm cov tshuaj tiv thaiv kab mob tiv thaiv kab mob sib kis nrog qhov tseem ceeb tsis xav tau kev kho mob. Lub Tuam Txhab siv txoj hauv kev tshwj xeeb thiab tsom mus rau kev txhim kho tshuaj tiv thaiv thiab tom qab ntawd siv nws txoj kev nkag siab tob txog kev txhaj tshuaj tiv thaiv kab mob txhawm rau txhim kho cov tshuaj tiv thaiv kab mob tiv thaiv kab mob no. Valneva tau siv nws qhov kev tshaj lij thiab muaj peev xwm ob qho los ua lag luam tau tiav ob hom tshuaj tiv thaiv thiab ua kom sai sai rau ntau qhov kev txhaj tshuaj tiv thaiv kab mob rau hauv thiab hla lub tsev kho mob, suav nrog cov neeg sib tw tiv thaiv kab mob Lyme, tus kab mob chikungunya thiab COVID-19.

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Hais txog qhov kev sau

Juergen T Steinmetz

Juergen Thomas Steinmetz tau ua haujlwm tsis tu ncua rau hauv kev lag luam ncig xyuas thiab kev lag luam txij li thaum nws tseem yog tub hluas ntxhais hluas hauv tebchaws Yelemes (1977).
Nws nrhiav tau eTurboNews nyob rau hauv 1999 yog thawj daim ntawv xov xwm online rau kev lag luam thoob ntiaj teb mus ncig ua si.

Cia ib saib