Ukwaphula Iindaba Zamanye Amazwe Iindaba zaseFransi ezaphulayo Iindaba zeMpilo abantu komzila Ngoku

Isitofu sokugonya esitsha se-COVID-19 ekwenziweni: Akukho ziphumo bezingalindelekanga!

IValneva SE os iphuhliswa yiDynavax Technologies Corporation Yinkampani edityaniswe ngokupheleleyo ye-biopharmaceutical egxile ekusebenziseni amandla omzimba ongaphakathi kunye neempendulo zomzimba eziguqukayo ngokukhuthaza iToll-like Receptor (TLR). I-Dynavax iyaphuhlisa, kwaye ithengise amayeza okugonya amanoveli.

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  • IValneva SE (Nasdaq: VALN; Euronext Paris: VLA), inkampani ekhethekileyo yokugonya, namhlanje ibhengeze iziphumo ezincomekayo kwisilingo sesi-3 sesilingo esibalulekileyo seCov-Thelekisa umgqatswa we-COVID-19 ongasebenziyo, oncedisayo, i-VLA2001.
  • Isigaba esibalulekileyo se-3, i-Cov-Thelekisa ulingo lufumene inani labathathi-nxaxheba abangama-4,012 abaneminyaka eli-18 nangaphezulu kwiindawo ezingama-26 zetyala eUnited Kingdom. Ityala lidibene neziphelo zalo zokuqala ezisisiseko: I-VLA2001 ibonakalise ukongama ngokuchasene ne-AZD1222 (ChAdOx1-S), ngokwejometri kuthetha titer ye-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)), kunye nokungajongelwa phantsi ngokwamazinga e-seroconversion rates (i-SCR ngaphezulu kwe-95% kuwo omabini amaqela onyango) kwiiveki ezimbini emva ugonyo lwesibini (okt uSuku lwama-43) kubantu abadala abaneminyaka engama-30 nangaphezulu.
  • Iimpendulo ze-T-cell ezihlalutyiweyo kuseto lwabathathi-nxaxheba zibonise ukuba i-VLA2001 inyanzelise i-antigen-ekhethekileyo ye-IFN-gamma evelisa iiseli ze-T ngokuchasene ne-S- (74.3%), N- (45.9%) kunye neM- (20.3%) protein.

I-VLA2001 yayihlala inyamezelwe kakuhle. Iprofayile yokunyamezelana ne-VLA2001 yayiyeyona nto ibaluleke ngakumbi xa kuthelekiswa nogonyo olusebenzayo lokuthelekisa. Abathathi-nxaxheba abaneminyaka engama-30 nangaphezulu baxele iziganeko ezimbi kakhulu ukuya kwiintsuku ezisixhenxe emva kogonyo, kokubini malunga nokusabela kwendawo yenaliti (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001) kunye nokuphendula kwenkqubo (70.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001).

Akukho ziganeko zibi kakhulu zinxulumene nonyango (SAE) ezixeliweyo. Ngaphantsi kwe-1% uxele isiganeko esibi somdla okhethekileyo kuwo omabini amaqela onyango. Abathathi-nxaxheba kwiqela elincinci lokugonywa nge-VLA2001 babonise iprofayili yokhuseleko xa kuthelekiswa neqela elidala.

Ukuvela kwamatyala e-COVID-19 (indawo yokugqibela yokuhlola) kwakufana phakathi kwamaqela onyango. Ukungabikho ngokupheleleyo kwazo naziphi na iimeko ezinzima ze-COVID-19 kungacebisa ukuba omabini amayeza okugonya asetyenziswe kolu phando athintele i-COVID-19 ebukhali ebangelwe kukuhluka okujikelezayo (ubukhulu becala kwe-Delta).

UAdam Finn, uNjingalwazi wePediatrics, iYunivesithi yaseBristol, uMphandi oyiNtloko weTyala, uthe: "Amanqanaba asezantsi e-reactogenicity kunye neempendulo eziphezulu ze-antibody ecaleni kweendlela ezibanzi ze-T-cell ezibonwe kunye nale ntsholongwane engasebenziyo yokuthintela intsholongwane iyamangalisa kwaye iyakhuthaza kakhulu. Le yeyona ndlela yemveli yokuvelisa isitofu kunalezi zitofu zisasetyenzisiweyo e-UK, eYurophu, naseMntla Melika kwaye ezi ziphumo zibonisa ukuba lo mgqatswa usekhondweni lokudlala indima ebalulekileyo ukoyisa ubhubhane. ”

UThomas Lingelbach, iGosa eliLawulayo eliyiNtloko laseValneva, uthe: “Ezi ziphumo zingqina iingenelo ezihlala zinxulunyaniswa nezitofu zentsholongwane ezingasebenziyo. Sizimisele ukuzisa umgqatswa wethu wokwahlula amayeza ukuba afumane amaphepha mvume ngokukhawuleza kwaye siqhubeke nokukholelwa ekubeni sizokwazi ukwenza igalelo elibalulekileyo kumlo wehlabathi wokulwa ubhubhane we-COVID-19. Sizimisele ukucebisa ngesinye isisombululo sokuthintela abantu abangekagonyelwa. ”

UJuan Carlos Jaramillo, MD, iGosa eliyiNtloko lezeMpilo eValneva, Ndathi: “Ndingathanda ukubulela abaphandi bamatyala kunye nabo bonke abathathi-nxaxheba kunye nabasebenzisana nabo, ngakumbi iZiko leSizwe loPhando ngezeMpilo kunye namaqela ezonyango akumaZiko oPhando e-NHS kunye neMpilo kaRhulumente yaseNgilani. Esi siphumo sibonisa ixabiso lentsebenziswano esiliqale ngeyoMsintsi yowama-2020 kwaye besingazukuyifumana le nto ngaphandle kwabo. Siza kuqhubeka sisebenza ngokusondeleyo ne-MHRA ukugqibezela ukungeniswa kwethu ukuze samkelwe. ”

UValneva uqalile ukungenisa ukuvuma okokuqala kwi-Arhente yoLawulo lweeMveliso zoNyango kunye neMveliso yoKhathalelo lwezeMpilo (MHRA) kwaye ulungiselela ukuqalisa ukungenisa ukuvuma kwemiqathango kwiArhente yamaYeza yaseYurophu. Ukuqinisekiswa kokugqibela kokuvavanywa okufunwa yi-MHRA ukuqinisekisa ukuthembeka kwedatha ye-VLA2001-301 ihlala iqhubeka kwaye iyimfuneko yokungeniswa kokugqibela kwengxelo yokufunda yeklinikhi.

Njengenxalenye yesicwangciso sophuhliso lweemveliso, uValneva ugqibezele ukugaya amavolontiya angama-306 aneminyaka engama-56 nangaphezulu eNew Zealand kuvavanyo lwayo lwe-VLA2001-304 kwaye ulindele idatha ephezulu kwangoko ekuqaleni kuka-2022. UValneva ukwabhengeze ukuqala kokugaywa kwabakwishumi elivisayo njenge ukwanda kwetyala leCov-Thelekisa[2].

Inkampani ilungiselela ukulingwa kwabantwana (abaneminyaka emi-5 ukuya kweli-12 ubudala) kunye novavanyo oluxhaswe nguValneva lokuvavanya ukusebenza kwe-VLA2001 yokukhuthaza abantu abadinga ukhuthazo.

Malunga neSigaba se-3 sovavanyo lweCov-Thelekisa (VLA2001-301)
I-Cov-Thelekisa (i-VLA2001-301) ilingo elingahleliwe, elingaboniyo, elilawulwayo, elilinganayo lokulingwa kwintsholongwane kubantu abadala abangama-4,012 nakwishumi elivisayo abangama-660. I-co-Primary i-immunogenicity endpoints iphakamile kumyinge we-GMT we-VLA2001 xa kuthelekiswa ne-AZD1222 (ChAdOx1-S) kunye nokungajongelwa phantsi kwamanqanaba e-seroconversion yokuthomalalisa ii-antibodies ezilawulwa kwishedyuli yokugonywa kweedosi ezimbini kwiiveki ezine ngokwahlukeneyo, kulinganiswa kwiiveki ezimbini emva ugonyo lwesibini (okt uSuku lwama-43) kubantu abadala abaneminyaka engama-30 nangaphezulu. Ikwavavanya ukhuseleko kunye nokunyamezeleka kwe-VLA2001 kwiiveki ezimbini emva kogonyo lwesibini kubantu abadala nakwishumi elivisayo abaneminyaka eli-12 nangaphezulu. Ityala liqhutywa kwiindawo ezingama-26 kulo lonke elase-UK 2,972 abathathi-nxaxheba abaneminyaka engama-30 ubudala nangaphezulu babengenangqondo kwi-2: 1 ratio yokufumana iidosi ezimbini ze-VLA2001 (n = 1,977) okanye i-AZD1222 (ChAdOx1-S) (n = 995) kwinqanaba ledosi elicetyiswayo, ngeentsuku ezingama-28 ukwahlukana, ngeentsuku zoku-1 nezingama-29. I-CoV-990 kuvavanyo yahlaziywa. Abathathi-nxaxheba abayi-492 abangaphantsi kweminyaka engama-2001 ubudala baqeshwa kwiqela elinganyanzelekanga lonyango kwaye bafumana i-VLA498 kwiintsuku ezingama-1222 ngaphandle. Idatha yezokhuseleko kwabo bathathi-nxaxheba beneminyaka eyi-1-2 ubudala ihlaziywa ngokuhambelana nabantu abadala abaneminyaka engama-1,040 nangaphezulu. Kutshanje, ityala laqala ukubhalisa abathathi-nxaxheba bokuqala abafikisayo.

Malunga ne-VLA2001
I-VLA2001 okwangoku kuphela kwentsholongwane iphela, engasebenziyo, umgqatswa wokugonya oncedisiweyo ngokuchasene ne-COVID-19 kuvavanyo lweklinikhi eYurophu. Kujongwe ukuba kugonywe abantu abasemngciphekweni wokuthintela ukuhambisa kunye nosulelo oluneempawu kunye ne-COVID-19 ngexesha lobhubhane oluqhubekayo kwaye kunokwenzeka kamva kugonyo oluqhelekileyo kubandakanya ukulungisa izinto ezintsha. I-VLA2001 inokuthi ikulungele ukonyusa, njengoko ukugonya okuphindiweyo okubonisiweyo kubonisiwe kusebenza kakuhle ngentsholongwane engasebenziyo. I-VLA2001 iveliswa kwiqonga leVero-cell elisekwe nguValneva, lisebenzisa iteknoloji yokuvelisa isitofu sokugonya se-encephalitis saseJapan, i-IXIARO®. I-VLA2001 inezinto ezingasebenziyo ngokupheleleyo zentsholongwane ye-SARS-CoV-2 enobunzima obuphezulu be-S-protein, ngokudityaniswa nezincedisi ezibini, i-alum kunye ne-CpG 1018. utshintsho kwimpendulo yomzimba yokuzikhusela ukuya kwi-Th1. I-CpG 1018 adjuvant, ebonelelwa yiDynavax Technologies Corporation (Nasdaq: DVAX), licandelo le-US FDA- kunye ne-EMA-evunyiweyo ye-HEPLISAV-B®  isitofu sokugonya. Inkqubo yokuvelisa i-VLA2001, esele inyuselwe kwinqanaba lokugqibela lemizi-mveliso, ibandakanya ukungasebenzi kweekhemikhali ukugcina ubume bendalo be-S-protein. I-VLA2001 kulindeleke ukuba ihambelane neemfuno eziqhelekileyo zokubanda (2 degrees ukuya kwi-8 degrees Celsius).

Malunga neValneva SE
UValneva yinkampani yokugonya ekhethekileyo egxile kuphuhliso kunye nentengiso yezitofu zokuthintela izifo ezosulelayo ezinesidingo esibalulekileyo sonyango. Inkampani ithatha indlela ekhethekileyo nejolisiweyo kuphuhliso lwesitofu kwaye emva koko isebenzise ukuqonda kwayo okunzulu ngenzululwazi yesitofu sokuphuhlisa izitofu zokuthintela ezithi zijongane nezi zifo. UValneva ubuphakamisile ubuchwephesha kunye namandla akhe ukuba athengise ngempumelelo amayeza okugonya kwaye aqhubele phambili ngokukhawuleza uluhlu olubanzi lwabagqirha ukuya kwiklinikhi, kubandakanya abagqatswa abachasene nesifo seLyme, intsholongwane ye-chikungunya kunye ne-COVID-19.

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Malunga nombhali

UJuergen T Steinmetz

UJuergen Thomas Steinmetz uqhubekile esebenza kwishishini lokuhamba nokhenketho okoko wafikisa eJamani (1977).
Uye waseka eTurboNews ngo-1999 njengephepha leendaba lokuqala kwi-intanethi kushishino lokhenketho lwehlabathi.

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