Umuthi wokugoma omusha we-COVID-19 ekwakhiweni: Ayikho imiphumela emibi!

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I-avatar ka-Juergen T Steinmetz

I-Valneva SE os ithuthukiswa yi-Dynavax Technologies Corporation Iyinkampani ehlanganiswe ngokugcwele ye-biopharmaceutical egxile ekusebenziseni amandla ezimpendulo zamasosha omzimba azalwa nazo neziguquguqukayo ngokusebenzisa i-Toll-like Receptor (TLR) stimulation. I-Dynavax iyathuthuka, futhi ihwebe ngemithi yokugoma yamanoveli.

  • IValneva SE (Nasdaq: VALN; Euronext Paris: I-VLA), inkampani ekhethekile yokugoma, namuhla imemezele imiphumela emihle emikhulu evela esivivinyweni esibaluleke kakhulu seSigaba 3 i-Cov-Compare yomqashi wayo wokugoma we-COVID-19 ongasebenzi, osetshenzisiwe, i-VLA2001.
  • Isivivinyo esibaluleke kakhulu sesiGaba sesi-3, se-Cov-Compare siqashe inani lababambe iqhaza abangama-4,012 abaneminyaka eyi-18 nangaphezulu ezindaweni ezingama-26 zokuhlola e-United Kingdom. Icala lihlangabezane neziphetho zalo eziyinhloko: I-VLA2001 ikhombise ukuphakama kuqhathaniswa ne-AZD1222 (ChAdOx1-S), ngokuya nge-geometric mean titer for 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)), kanye nokungahloniphi ngokwamazinga we-seroconversion rates (i-SCR engaphezulu kwama-95% kuwo womabili amaqembu okwelashwa) emasontweni amabili ngemuva ukugoma kwesibili (okusho uSuku 43) kubantu abadala abaneminyaka engama-30 nangaphezulu.
  • Izimpendulo ze-T-cell ezihlaziyiwe kusethi yabahlanganyeli zikhombisile ukuthi i-VLA2001 idale i-IFN-gamma ebanzi ekhiqiza i-anti-ethize ekhiqiza ama-T-cell asebenzayo ngokumelene ne-S- (74.3%), N- (45.9%) ne-M- (20.3%) amaprotheni.

I-VLA2001 yayijwayele ukubekezelelwa kahle. Iphrofayili yokubekezelela i-VLA2001 yayithandeka kakhulu uma iqhathaniswa nomuthi wokugomela osebenzayo. Ababambiqhaza abaneminyaka engama-30 nangaphezulu babike imicimbi emibi kakhulu eceliwe kuze kube yizinsuku eziyisikhombisa ngemuva kokugonywa, zombili maqondana nokuphendula kwesiza somjovo (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001) kanye nokusabela kwesistimu (70.2% I-VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001).

Azikho izehlakalo ezimbi kakhulu ezihlobene nokwelashwa ezingacelwanga ezibikiwe (SAE) ezibikiwe. Ngaphansi kuka-1% babike umcimbi omubi wentshisekelo ekhethekile kuwo womabili amaqembu okwelashwa. Ababambe iqhaza eqenjini elincane eligonywe nge-VLA2001 bakhombise iphrofayili yezokuphepha isiyonke efana neqembu elidala.

Ukutholakala kwamacala e-COVID-19 (indawo yokugcina yokuhlola) bekufana phakathi kwamaqembu ezokwelapha. Ukungabikho ngokuphelele kwanoma yimaphi amacala abucayi e-COVID-19 kungaphakamisa ukuthi yomibili imigomo esetshenziswe ocwaningweni ivikele i-COVID-19 ebucayi ebangelwe ukuhlukahluka okujikelezayo (ikakhulu i-Delta).

U-Adam Finn, uSolwazi Wezingane, Inyuvesi yaseBristol, Umphenyi Oyinhloko Wezokulingwa, wathi: “Amazinga aphansi e-reactogenicity kanye nezimpendulo eziphezulu ze-antibody eceleni kwezimpendulo ze-T-cell ezibanzi ezibonwe ngalo muthi wokugomela igciwane ophelele ongasetshenziswanga uyamangalisa futhi uyakhuthaza kakhulu. Lena indlela yendabuko yokwenziwa kwemithi yokugoma kunaleyo yokugoma okwamanje esatshalaliswe e-UK, eYurophu, naseNyakatho Melika futhi le miphumela ikhomba ukuthi lo muntu ozongenela umgomo usendleleni yokudlala indima ebalulekile ekunqobeni ubhadane. ”

UThomas Lingelbach, Isikhulu Esiphezulu se-Valneva, yathi: “Le miphumela iqinisekisa izinzuzo ezivame ukuhlotshaniswa nemithi yokugomela lonke igciwane engasebenzi. Sizibophezele ekuletheni ozobhapathizwa wethu womgomo ohlukanisiwe ukuba athole amalayisense ngokushesha okukhulu futhi aqhubeke nokukholelwa ukuthi sizokwazi ukwenza iqhaza elibalulekile empini yomhlaba yokulwa nobhadane lwe-COVID-19. Sizimisele ukuphakamisa esinye isisombululo somuthi wokugomela abantu abangakagonywe. ”

UJuan Carlos Jaramillo, MD, Isikhulu Esiphezulu Sezokwelapha eValneva, uphawule wathi: “Ngithanda ukubonga abaphenyi bamacala kanye nabo bonke ababambiqhaza kanye nabahlanganyeli, ikakhulukazi iNational Institute for Health Research kanye namaqembu emitholampilo ngaphakathi kweNHS Research Centers kanye ne-Public Health England. Lo mphumela ukhombisa ukubaluleka kokubambisana esikuqale ngoSepthemba 2020 futhi besingeke sifeze le ngqophamlando ngaphandle kwabo. Sizoqhubeka nokusebenzisana kakhulu ne-MHRA ukuqedela ukuthunyelwa kwethu okugunyaziwe ukuvunywa. ”

UValneva uqale ukuhambisa ukuhanjiswa ukuze avunyelwe okokuqala yi-UK's Medicines and Healthcare product Regulatory Agency (MHRA) futhi ulungiselela ukuqala ukuhambisa okuhambisanayo ukuze kuvunyelwe imibandela ne-European Medicines Agency. Ukuqinisekiswa kokugcina kwesilingo okudingwa yi-MHRA ukuqinisekisa ubuqiniso bemininingwane ye-VLA2001-301 kuhlala kuqhubeka futhi kuyisidingo sokwethulwa kokugcina kombiko wesifundo somtholampilo.

Njengengxenye yecebo lokuthuthukisa umkhiqizo, uValneva uqede ukuqashwa kwamavolontiya angama-306 aneminyaka engama-56 nangaphezulu eNew Zealand esivivinyweni sakhe se-VLA2001-304 futhi ulindele imininingwane ephezulu ekuqaleni kuka-2022. UValneva ubuye wamemezela ukuqala kokuqashwa kwentsha njenge-an ukunwetshwa kwesivivinyo seCov-Qhathanisa[2].

Inkampani ilungiselela izivivinyo ezinganeni (ezineminyaka engu-5 kuya kwengu-12 ubudala) kanye nesilingo esixhaswe yiValneva sokuhlola ukusebenza kwe-VLA2001 booster kubantu abadinga i-booster.

Mayelana neSigaba 3 Trial Cov-Qhathanisa (VLA2001-301)
I-Cov-Compare (i-VLA2001-301) isilingo esingahleliwe, esibukelayo, esilawulwayo, sokuqhathanisa se-immunogenicity kubantu abadala abangama-4,012 kanye nentsha engama-660. Amaphuzu okuphela kwe-Co-Primary immunogenicity angaphezulu kwesilinganiso se-GMT se-VLA2001 uma kuqhathaniswa ne-AZD1222 (ChAdOx1-S) kanye nokungabi naphansi kwamazinga we-seroconversion wama-antibactering afakwa ohlelweni lokugoma ngemithamo emibili amasonto amane ahlukene, kukalwa emasontweni amabili ngemuva ukugoma kwesibili (okusho uSuku 43) kubantu abadala abaneminyaka engama-30 nangaphezulu. Iphinde ihlole ukuphepha nokubekezelela i-VLA2001 emasontweni amabili ngemuva kokugonywa kwesibili kubantu abadala nasebasha abaneminyaka eyi-12 nangaphezulu. Icala lenzelwa ezindaweni ezingama-26 kulo lonke elase-UK 2,972 ababambiqhaza abaneminyaka engu-30 nangaphezulu bahlelwa ngokulinganisa okungu-2: 1 ukuthola imithamo emibili ye-VLA2001 (n = 1,977) noma i-AZD1222 (ChAdOx1-S) (n = 995) ezingeni lomthamo onconywayo, ukuhlukaniswa kwezinsuku ezingama-28, ngezinsuku 1 no-29. Ukuhlaziywa kwe-immunogenicity, amasampuli avela kubahlanganyeli abangama-990 (492 agonywe nge-VLA2001, ama-498 agonywe nge-AZD1222 (ChAdOx1-S)) ahlolwe i-sero-negative ye-SARS- I-CoV-2 ekuhlolweni yahlaziywa. Abahlanganyeli be-1,040 abangaphansi kweminyaka engama-30 ubudala baqashwa eqenjini lokwelashwa elingahleliwe futhi bathola i-VLA2001 izinsuku ezingama-28 zihlukene. Imininingwane yokuphepha kulabo ababambiqhaza abaneminyaka engu-18-29 ubudala ihlaziywa ngokufana nabantu abadala abaneminyaka engama-30 nangaphezulu. Muva nje, icala liqale ukubhalisa ababambiqhaza bokuqala abasebasha.

Cishe i-VLA2001
I-VLA2001 njengamanje iwukuphela kwegciwane eliphelele, elingasetshenziswanga, elenzelwe umuthi wokugoma olwa ne-COVID-19 ezivivinyweni zokwelashwa eYurophu. Kuhloselwe ukugoma okusebenzayo kwabantu abasemngciphekweni ukuvimbela ukuhanjiswa kanye nokutheleleka okuyizimpawu nge-COVID-19 ngesikhathi sobhadane oluqhubekayo futhi okungenzeka kamuva kokugoma okujwayelekile kubandakanya ukubhekana nokuhlukahluka okusha. I-VLA2001 nayo ingakulungela ukukhuphula amandla, njengoba imigomo yokuphinda ama-booster ikhonjisiwe ukuthi isebenza kahle ngayo yonke imigomo engasebenzi igciwane. IVLA2001 ikhiqizwa epulatifomu likaValneva elisungulwe iVero-cell, isebenzisa ubuchwepheshe bokukhiqiza umuthi wokugomela i-encephalitis waseJapan waseValneva, IXIARO®. I-VLA2001 iqukethe izinhlayiya zegciwane ezingasebenzi lonke ze-SARS-CoV-2 ezinamandla amakhulu we-S-protein, ngokuhlanganiswa nezandiso ezimbili, i-alum kanye ne-CpG 1018. Le nhlanganisela ye-adjuvant ibilokhu inyusa amazinga aphezulu e-antibody ekuhlolweni kwe-preclinical kunokwakhiwa kwe-alum-kuphela futhi kukhonjisiwe ukuguqulwa kwempendulo yokuzivikela komzimba ku-Th1. I-CpG 1018 adjuvant, enikezwe yiDynavax Technologies Corporation (Nasdaq: DVAX), iyinxenye ye-US FDA- ne-EMA egunyazwe i-HEPLISAV-B®  umuthi wokugoma. Inqubo yokukhiqiza ye-VLA2001, esivele inyuselwe ezingeni lokugcina lezimboni, ifaka ukungasebenzi kwamakhemikhali ukugcina ukwakheka kwendabuko kwe-S-protein. I-VLA2001 kulindeleke ukuthi ihambisane nezidingo ezijwayelekile zamakhaza abandayo (2 degrees kuya ku-8 degrees Celsius).

Mayelana noValneva SE
IValneva yinkampani yokugoma ekhethekile egxile ekwakhiweni nasekuthengisweni kwemithi yokugoma ye-prophylactic yezifo ezithathelwanayo ezinesidingo esikhulu sezokwelapha esingafinyelelwanga. Inkampani ithatha indlela ekhetheke kakhulu futhi ehlosiwe ekuthuthukiseni umuthi wokugoma bese isebenzisa ukuqonda kwayo okujulile kwesayensi yokugoma ukwenza imishanguzo yokuvikela imithi ebhekana nalezi zifo. IValneva isebenzise ubuchwepheshe namakhono ayo ekuthengiseni ngempumelelo imishanguzo emibili nokuqhubekisela phambili ngokushesha uhla olubanzi lwabazongenela umuthi emtholampilo nangaphakathi, kubandakanya nabazongenela isifo i-Lyme, igciwane le-chikungunya ne-COVID-19.

Mayelana umbhali

I-avatar ka-Juergen T Steinmetz

UJuergen T Steinmetz

UJuergen Thomas Steinmetz ubelokhu esebenza ngokuqhubekayo embonini yezokuvakasha nezokuvakasha kusukela esemusha eJalimane (1977).
Wasungula eTurboNews ngo-1999 njengencwajana yokuqala ye-inthanethi embonini yezokuvakasha yezokuvakasha emhlabeni jikelele.

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