Kuswa Nkhani Zapadziko Lonse Nkhani Zaku France Health News anthu Trending Tsopano

Katemera Watsopano wa COVID-19 popanga: Palibe zovuta!

Valneva SE os yopangidwa ndi Dynavax Technologies Corporation Ndi kampani yophatikiza biopharmaceutical yokhazikika pakukhazikitsa mphamvu zamaganizidwe amthupi obwera chifukwa chothandizidwa ndi Toll-like Receptor (TLR). Dynavax ikukula, ndikugulitsa katemera watsopano.

Sangalalani, PDF ndi Imelo
  • Valneva SE (Nasdaq: VALN; E.)uronext Paris: VLA), kampani yapadera ya katemera, lero yalengeza zotsatira zabwino pamilandu yayikulu yoyesedwa ndi Phase 3 Cov-Compare ya katemera wa COVID-19, VLA2001.
  • Gawo lofunikira kwambiri 3, Cov-Fananizani mayankho omwe adalemba onse omwe atenga nawo mbali 4,012 azaka zapakati pa 18 ndi kupitilira malo oyeserera a 26 ku United Kingdom. Mlanduwo udakwaniritsa zomaliza zake: VLA2001 idawonetsa kupambana motsutsana ndi AZD1222 (ChAdOx1-S), potengera geometric kutanthauza titer ya ma neutralization antibodies (GMT ratio = 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)), komanso kusadzichepetsera malinga ndi kuchuluka kwa ma seroconversion (SCR pamwamba pa 95% m'magulu onse azachipatala) patatha milungu iwiri Katemera wachiwiri (mwachitsanzo Tsiku 43) mwa akulu azaka 30 kapena kupitilira apo.
  • Mayankho a T-cell omwe adasanthula pagulu la omwe atenga nawo mbali adawonetsa kuti VLA2001 idapangitsa kuti ma anti-enieni a IFN-gamma opanga ma T-cell agwirizane ndi S- (74.3%), N- (45.9%) ndi M- (20.3%) mapuloteni.

VLA2001 nthawi zambiri imaloledwa bwino. Mbiri yolekerera ya VLA2001 inali yabwino kwambiri poyerekeza ndi katemera wofanizira. Ophunzira omwe ali ndi zaka 30 kapena kupitilira apo adatinso zocheperako mpaka masiku asanu ndi awiri atalandira katemera, zonse zokhudzana ndi mayankho a malo (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001) ndi machitidwe amachitidwe (70.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001).

Palibe zochitika zoyipa zosagwirizana ndi chithandizo (SAE) zomwe zafotokozedwa. Ochepera 1% adanenapo chochitika chovuta kwambiri m'magulu onse azachipatala. Ophunzira omwe ali mgulu laling'ono omwe adalandira katemera wa VLA2001 adawonetsa chitetezo chonse chofanana ndi gulu lakale.

Zomwe zimachitika pamilandu ya COVID-19 (malo omaliza ofufuza) zinali zofanana pakati pa magulu azachipatala. Kusapezeka kwathunthu kwa milandu yayikulu ya COVID-19 kungatanthauze kuti katemera onse omwe agwiritsidwa ntchito mu kafukufukuyu adateteza COVID-19 yayikulu yoyambitsidwa ndi mitundu ina (makamaka) ya Delta.

Adam Finn, Pulofesa wa Paediatrics, University of Bristol, Woyesa Kafukufuku Wamkulu, anati: "Magulu otsika a reactogenicity ndi mayankho ogwira ntchito a antibody limodzi ndi mayankho otakata a T-cell omwe amawonedwa ndi katemerayu wothandizidwa ndi kachilombo koyambitsa matendawa ndiabwino komanso olimbikitsa kwambiri. Imeneyi ndi njira yodziwika bwino yopangira katemera kuposa katemera yemwe wagwiritsidwa ntchito ku UK, Europe, ndi North America ndipo zotsatirazi zikusonyeza kuti wofuna katemerayu ali ndi gawo lofunikira kuthana ndi mliriwu. ”

Thomas Lingelbach, Chief Executive Officer wa Valneva, anati: “Zotsatirazi zikutsimikizira maubwino omwe nthawi zambiri amakhala nawo chifukwa cha katemera wa virus wosagwira. Ndife odzipereka kubweretsa ofuna kudzalandira katemera mwachangu mwachangu momwe angathere ndikupitilizabe kukhulupirira kuti titha kuthandiza pantchito yolimbana ndi mliri wa COVID-19. Tikufuna kupereka njira yothetsera katemera kwa anthu omwe sanalandirebe katemera. ”

Juan Carlos Jaramillo, MD, Dokotala Wamkulu ku Valneva, anati: "Ndikufuna kuthokoza ofufuzawo komanso onse omwe akuchita nawo kafukufukuyu komanso omwe akuchita nawo mgwirizano, makamaka National Institute for Health Research ndi magulu azachipatala omwe ali m'malo a NHS Research Centers komanso Public Health England. Izi zikuwonetsa kufunikira kwa mgwirizano womwe tidayamba mu Seputembara 2020 ndipo sitikanatha kukwaniritsa izi popanda iwo. Tipitiliza kugwira ntchito limodzi ndi MHRA kuti timalize ntchito yathu yovomereza. ”

Valneva adayamba kutumiza kovomerezeka kuti avomerezedwe koyamba ndi UK's Medicines and Healthcare product Regulatory Agency (MHRA) ndipo akukonzekera kuyambiranso kutumiza kuvomerezedwa ndi European Medicines Agency. Kutsimikizika komaliza kofunidwa ndi MHRA kuti atsimikizire kukhulupirika kwa zomwe VLA2001-301 idapitilizabe ndipo ndichofunikira pakufikitsa komaliza lipoti la kafukufuku wamankhwala.

Monga gawo la njira yopangira zinthu, Valneva watsiriza kufunsa anthu 306 azaka zapakati pa 56 ndi kupitilira apo ku New Zealand kuti ayesedwe pamlandu wawo wa VLA2001-304 ndipo akuyembekeza kuti azidziwika bwino kumayambiriro kwa chaka cha 2022. Valneva walengezanso kuyambanso kolemba achinyamata ngati Kukula kwa mayeso a Cov-Compare[2].

Kampani ikukonzekera mayesero kwa ana (azaka 5-12 zakubadwa) ndipo a Valneva adathandizira kuyesa chilimbikitso kuti awunikire magwiridwe antchito a VLA2001 kwa anthu omwe akufunikira chilimbikitso.

About Phase 3 Trial Cov-Compare (VLA2001-301)
Cov-Compare (VLA2001-301) ndiwosasinthika, wowonera, wakhungu, woyeserera, woyeserera wa immunogenicity mwa akulu 4,012 ndi achinyamata a 660. Mapeto a Co-Primary immunogenicity ndiwowonjezera kuchuluka kwa GMT kwa VLA2001 poyerekeza ndi AZD1222 (ChAdOx1-S) komanso kuchepa kwa kuchuluka kwa ma seroconversion olepheretsa ma antibodies omwe amapatsidwa katemera wa magawo awiri patatha milungu inayi, kuyesedwa patatha milungu iwiri Katemera wachiwiri (mwachitsanzo Tsiku 43) mwa akulu azaka 30 kapena kupitilira apo. Imawunikiranso chitetezo ndi kulolerana kwa VLA2001 pakatha milungu iwiri katemera wachiwiri kwa akulu ndi achinyamata azaka 12 kapena kupitilira apo. Mlanduwu ukuchitika pamasamba 26 ku UK omwe ali ndi zaka 2,972 omwe ali ndi zaka 30 kapena kupitilira apo adasinthidwa mu 2: 1 ratio kuti alandire minyewa iwiri ya VLA2001 (n = 1,977) kapena AZD1222 (ChAdOx1-S) (n = 995) pamlingo wovomerezeka, masiku 28 atatsala, pa Masiku 1 ndi 29. Pofuna kusanthula thupi, zitsanzo kuchokera kwa omwe akutenga nawo mbali 990 (492 adalandira katemera wa VLA2001, 498 adalandira katemera wa AZD1222 (ChAdOx1-S)) yemwe adayesa sero-negative kwa SARS- CoV-2 pakuwunika idasanthulidwa. Ophunzira 1,040 omwe sanakwanitse zaka 30 adalembedwa m'gulu lazachipatala losasankhidwa ndipo adalandira VLA2001 masiku 28 atasiyana. Zambiri zachitetezo mwa omwe atenga nawo gawo azaka za 18-29 azisankhidwa mofanana ndi achikulire azaka 30 kapena kupitilira apo. Posachedwa, mlanduwu udayamba kulembetsa nawo achinyamata oyamba kutenga nawo mbali.

Pafupi VLA2001
VLA2001 pakadali pano ndiye kachilombo kokhako, kachilombo koyambitsa matenda opatsirana, kothandizidwa ndi katemera wa COVID-19 m'mayesero azachipatala ku Europe. Amapangidwa kuti ateteze anthu omwe ali pachiwopsezo choteteza kachilombo ndi matenda opatsirana ndi COVID-19 panthawi ya mliri womwe ukupitilira komanso pambuyo pake katemera wanthawi zonse kuphatikiza mitundu yatsopano. VLA2001 itha kukhalanso yoyenera kupititsa patsogolo, chifukwa katemera wobwereza awonetsedwa kuti ukugwira ntchito bwino ndi katemera wathunthu wama virus. VLA2001 imapangidwa papulatifomu ya Vero-cell yomwe a Valneva adakhazikitsa, pogwiritsa ntchito ukadaulo wopanga katemera wa Valceva wokhala ndi zilolezo ku Japan encephalitis, IXIARO®. VLA2001 imakhala ndimatenda athunthu osakanikirana a SARS-CoV-2 okhala ndi S-protein osakanikirana, kuphatikiza ophatikizira awiri, alum ndi CpG 1018. Kuphatikizana kwa adjuvant kumeneku kwapangitsa kuti magazi azitetezedwa kwambiri poyeserera kuposa ma alum okhawo ndikuwonetsa kusintha kwa chitetezo cha mthupi kupita ku Th1. CpG 1018 wothandizira, woperekedwa ndi Dynavax Technologies Corporation (Nasdaq: DVAX), ndi gawo limodzi la US FDA- ndi EMA lovomerezeka HEPLISAV-B®  katemera. Njira yopangira VLA2001, yomwe idakwezedwa kale mpaka mafakitale omaliza, imaphatikizapo kusakhazikika kwa mankhwala kuti asunge kapangidwe ka protein ya S. VLA2001 ikuyembekezeka kutengera zofunikira za unyolo wozizira (2 madigiri mpaka 8 madigiri Celsius).

Malingaliro a kampani Valneva SE
Valneva ndi kampani yapadera ya katemera yomwe imayang'ana kwambiri pakupanga ndi kugulitsa katemera wa prophylactic wa matenda opatsirana omwe ali ndi zosowa zamankhwala zosakwaniritsidwa. Kampani imagwiritsa ntchito njira yodziwika bwino yolimbana ndi katemera ndikugwiritsa ntchito chidziwitso chakuya cha sayansi ya katemera kupanga katemera wa prophylactic wothana ndi matendawa. Valneva yagwiritsa ntchito ukadaulo wake komanso kuthekera kwake kugulitsa bwino katemera awiri ndikupititsa patsogolo mwachangu anthu ambiri opita katemera kulowa kuchipatala, kuphatikiza omwe akufuna kudwala matenda a Lyme, chikungunya virus ndi COVID-19.

Sangalalani, PDF ndi Imelo

Ponena za wolemba

Wachinyamata T Steinmetz

Juergen Thomas Steinmetz wakhala akugwirabe ntchito zapaulendo komanso zokopa alendo kuyambira ali wachinyamata ku Germany (1977).
Iye adayambitsa eTurboNews mu 1999 ngati nkhani yoyamba yapaintaneti yantchito zapaulendo padziko lonse lapansi.

Siyani Comment