Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), o se kamupani tuʻufaʻapitoa tui puipuia, aso nei na folafolaina lelei topline iʻuga mai le Phase 3 taua faʻamasinoga Cov-Faʻatusatusa o lona le faʻagaoioia, adjuvanted COVID-19 tui sui tauva, VLA2001.
O le taua o le Vaega 3, Cov-Faʻatusatusa faʻataʻitaʻiga suʻeina le aofaʻi o 4,012 tagata auai 18 tausaga le matutua i luga atu 26 faʻataʻitaʻiga nofoaga i le United Kingdom. O le faʻamasinoga na feiloaʻi ma faʻaiʻuga autu: VLA2001 faʻaalia le sili atu i le AZD1222 (ChAdOx1-S), i le tulaga o le geometric uiga titer mo le faʻamamaina o vailaʻau (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)), faʻapea foi ma le le maualalo i tulaga o seroconversion fua faatatau (SCR i luga 95% i vaega togafitiga uma) i le lua vaiaso talu le tui lona lua (ie Aso 43) i tagata matutua e 30 tausaga le matutua pe sili atu.
T-cell tali na suʻesuʻeina i se vaega laiti o tagata auai na faʻaalia ai o le VLA2001 na faʻaosofia le lautele antigen-faʻapitoa IFN-gamma gaosia T-sela toe faʻamalosia e faasaga i le S- (74.3%), N- (45.9%) ma le M- (20.3%) porotini.

VLA2001 na masani ona talia lelei. O le faʻapalepale faʻamatalaga o le VLA2001 na sili atu ona alofagia pe a faʻatusatusa i le vailaʻau tui galue malosi. O tagata na auai i le 30 tausaga ma sili atu na lipotia mai e toalaiti lava le aofai o mea leaga na tutupu e oʻo atu i le fitu aso talu ona uma le tui, e faatatau i aafiaga o le tuiina (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001) ma lagona faʻaalia (70.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001).

Leai se faʻamalosia togafitiga faʻatatau-fesoʻotaʻi mataga leaga (SAE) na lipotia mai. I lalo ifo o le 1% lipotia se faʻalavelave matuia o le fiafia faapitoa i vaega togafitiga e lua. O tagata na auai i vaega laiti na tuiina ile VLA2001 na faʻaalia se tulaga lautele o le saogalemu e faʻatusatusa ile matutua tausaga.

O le tutupu mai o COVID-19 mataupu (exploratory endpoint) na tutusa i le va o vaega togafitiga. O le leai atoa o ni mataupu ogaoga COVID-19 atonu e taʻu mai ai o tui uma e lua na faaaoga i le suʻesuʻega na taofia ai le ogaoga o le COVID-19 e mafua mai i le taamilosaga (s) Delta).

Adam Finn, Polofesa o Paediatrics, Iunivesite o Bristol, Trial Chief Investigator, Fai mai: "O le maualalo o le reactogenicity ma le maualuga o le tali atu o le vailaʻau faʻamalosi tino i autafa o le lautele o le T-cell tali na vaʻaia ma lenei vailaʻau o le siama atoa ua le toe faʻagaoioia e mataʻina ma faʻamalosia foi. O se auala masani lenei i le faiga o tui nai lo tui ua leva ona faaaogaina i Peretania, Europa, ma Amerika i Matu ma o nei iʻuga e taʻu mai ai o lenei tui sui tauva o loo i ai i le ala e taua tele i le foiaina o le faʻamaʻi. "

Thomas Lingelbach, Ofisa Sili o Pulega o Valneva, Fai mai: "O nei iʻuga e faʻamaonia ai le lelei e masani ona fesoʻotaʻi ma tui puipuia o siama atoa. Matou te naunau e aumai le matou sui tauva tui i le laisene i se vave e mafai ai ma faʻaauau pea ona talitonu o le a mafai ona matou faia se sao taua i le taua i le lalolagi faʻasaga i le faʻamaʻi o le COVID-19. Matou te naunau e fai se isi fofo o vailaʻau mo tagata e leʻi tuiina. "

Juan Carlos Jaramillo, MD, Ofisa Sili o Fomaʻi o Valneva, faʻapea: "Ou te fia faʻafetai i tagata suʻesuʻe faʻataʻitaʻi faʻapea foi ma i latou uma na auai faʻataʻitaʻi ma tagata galulue faʻatasi, aemaise le National Institute for Health Research ma vaega faʻafomaʻi i totonu o le NHS Research Centres faʻapea ai ma le Public Health England. Lenei iʻuga faʻaalia ai le taua o le galulue faʻatasi na matou amata ia Setema 2020 ma e le mafai ona tatou ausia lenei mea taua e aunoa ma latou. O le a faʻaauau pea ona matou galulue vavalalata ma le MHRA e faʻamaeʻa la matou folasaga mo le faʻamaonia. "

Valneva amata faʻasolosolo tuʻuina atu mo le uluaʻi faʻamaonia ma le UK's Medicines and Healthcare oloa Regulate Agency (MHRA) ma o loʻo sauni e amata faʻasolosolo tuʻuina atu mo faʻamaonia tuʻutuʻu ma le European Medicines Agency. Ole suʻega mulimuli na manaʻomia e le MHRA e faʻamaonia ai le faʻamaoni o le VLA2001-301 faʻamaumauga o loʻo tumau pea ma o se mea e manaʻomia muamua mo le faʻamaeʻaina mulimuli o le lipoti suʻesuʻe a le falemaʻi.

I le avea ai o se vaega o le atinaʻe o oloa, Valneva ua maeʻa ona faafaigaluegaina le 306 volenitia mai le 56 tausaga le matutua i totonu o Niu Sila i totonu o lana VLA2001-304 faamasinoga ma o loʻo faamoemoe topline faʻamaumauga i le amataga o le 2022. faʻalauteleina o le Cov-Faʻatusatusa faʻamasinoga[2].

O loʻo sauniuni le Kamupani mo faʻataʻitaʻiga i tamaiti (5-12 tausaga le matutua) ma le Valneva na lagolagoina le faʻamalosiʻau faʻamalosiʻau e iloilo le VLA2001's booster performance mo tagata manaʻomia se booster.

E uiga ile Vaega 3 Fa'ata'ita'iga Cov-Fa'atusatusa (VLA2001-301)
Cov-Faʻatusatusa (VLA2001-301) o se faʻasolosolo, mataitu-tauaso, faʻatonutonu, faʻatusatusa faʻamalositino faʻataʻitaʻi i 4,012 tagata matutua ma 660 talavou. Co-Peraimeri manatu faʻaiuga o le sili atu o GMT fuafaatatau o VLA2001 faʻatusatusa i le AZD1222 (ChAdOx1-S) faʻapea foi ma le le maualalo o le seroconversion fua faatatau o le faʻamamaina o vailaʻau faʻataʻitaʻi e faia i le lua-inumua tui puipuia faʻavasega fa vaiaso vavae ese, fuaina i le lua vaiaso mulimuli ane le tui lona lua (ie Aso 43) i tagata matutua e 30 tausaga le matutua pe sili atu. E iloiloina ai foʻi le saogalemu ma le gafataulimaina ole VLA2001 ile lua vaiaso talu le tui lona lua i tagata matutua ma talavou e 12 tausaga le matutua. O le faamasinoga o loo faia i 26 nofoaga i le salafa o le UK 2,972 tagata auai 30 tausaga o le matutua ma sili atu na randomized i le 2: 1 fua faatatau e maua ai lua intramuscular tolo o VLA2001 (n = 1,977) po o AZD1222 (ChAdOx1-S) (n = 995) i le tulaga fautuaina fualaʻau, 28 aso vavaeʻese, i Aso 1 ma le 29. Mo faʻataʻitaʻiga o le faʻamalosiʻau, faʻataʻitaʻiga mai le 990 tagata na auai (492 na tuiina i le VLA2001, 498 na tuiina i le AZD1222 (ChAdOx1-S)) na faʻataʻitaʻia le le lelei mo le SARS- CoV-2 i le suʻega na suʻesuʻeina. 1,040 sui auai e i lalo o le 30 tausaga le matutua na faʻafaigaluegaina i se le faʻasolosolo togafitiga togafitiga ma mauaina VLA2001 28 aso vavae ese. O faʻamaumauga saogalemu mo i latou na auai 18-29 tausaga le matutua o loʻo suʻesuʻeina faʻatusatusa i tagata matutua 30 tausaga o luga atu. Talu ai nei, na amata ai le faʻamasinoga na lesitalaina muamua tamaiti na auai.

E tusa o le VLA2001
O le VLA2001 ua naʻo le pau lea o le siama atoa, ua le toe faʻagaoioia, o le sui o tui puipuia faasaga i le COVID-19 i faʻataʻitaʻi falemaʻi i Europa. E faʻamoemoeina mo le tui puipuia o tagata e ono aʻafia e puipuia ai taʻavale ma faʻamaʻi pipisi ma le COVID-19 i le taimi o le faʻamaʻi pipisi ma ono mulimuli ane mo tui masani e aofia ai le faʻatalanoaina o ni suiga fou. VLA2001 atonu e talafeagai mo le faʻamalosia, ona ua toe faʻamalosia le faʻamalosia o tui ua faʻaalia e galue lelei ma le atoa siama inactivated tui. VLA2001 o loʻo gaosia i luga o le faʻamaumauga Vero-cell faʻavae a Valneva, faʻaaogaina ai o tekonolosi mo le faia o tui laisene Iapani ensefalitis a Iapani, o Valneva, IXIARO^®. VLA2001 aofia ai le faʻagaoioia vaega siama atoa o SARS-CoV-2 ma maualuga S-polotini density, faatasi ai ma lua adjuvants, alum ma CpG 1018. se suiga o le tali atu le puipuia agai Th1. CpG 1018 adjuvant, sapalaiina e Dynavax Technologies Corporation (Nasdaq: DVAX), o se vaega o le US FDA- ma le EMA-faamaonia HEPLISAV-B^® tui O le gaosiga o gaioiga mo VLA2001, lea ua maeʻa ona siʻitia i le tulaga tau alamanuia mulimuli, e aofia ai le le toe faʻagaoioia o vailaʻau e faʻasao ai le fausaga o le S-protein. VLA2001 e faʻamoemoe e faʻafetaui ma tulaga masani malulu filifili filifili (2 tikeri i le 8 tikeri Celsius).

E uiga i Valneva SE
Valneva o se faʻapitoa tui kamupani faʻatauaina i luga o le atinaʻe ma faʻapisinisi o tui puipui prophylactic mo faʻamaʻi pipisi ma le taua tele le manaʻomia fomaʻi. O le Kamupani na te faia se faʻapitoa faʻapitoa ma faʻatatauina auala i tui atinaʻe ma faʻapipiʻi lona loloto malamalamaʻaga o tui Saienisi e atiaʻe prophylactic tui faʻafitauli nei faʻamaʻi. Valneva ua faʻaaogaina lona tomai ma agavaʻa uma e faʻatautaia ma le manuia ni vailaʻau se lua ma ia vave alualu i luma le tele o ituaiga o tui sui tauva i totonu ma ala atu i le falemaʻi, e aofia ai sui tauva faasaga i le Lyme faamaʻi, o le chikungunya virus ma le COVID-19.

OA MEA E AVEA MAI LENEI TUSI:

This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the UK, Europe, and North America and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic.
A final assay validation required by the MHRA to verify the integrity of the VLA2001-301 data remains ongoing and is a prerequisite for the final submission of the clinical study report.
The Company is preparing for trials in children (5-12 years of age) and a Valneva sponsored booster trial to evaluate VLA2001's booster performance for people in need of a booster.