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Sabuwar rigakafin COVID-19 a cikin yin: Babu sakamako masu illa!

Valneva SE os being developed by Dynavax Technologies Corporation It is a fully-integrated biopharmaceutical company focused on leveraging the power of the body’s innate and adaptive immune responses through Toll-like Receptor (TLR) stimulation. Dynavax develops, and commercializes novel vaccines.

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  • Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), wani kamfani na allurar rigakafi na musamman, a yau ya ba da sanarwar sakamako mai kyau daga gwajin gwaji mai mahimmanci na Cov-Compare na mara aiki, wanda ya dace da ɗan takarar rigakafin COVID-3, VLA19.
  • Mataki na 3 mai mahimmanci, gwajin Cov-Compare ya tattara jimlar mahalarta 4,012 masu shekaru 18 zuwa sama da shafuka 26 na gwaji a Burtaniya. Jarabawar ta sadu da ƙarshen abubuwan haɗin gwiwa: VLA2001 ya nuna fifiko akan AZD1222 (ChAdOx1-S), dangane da ma'anar geometric ma'anar titer don rigakafin ƙwayoyin cuta (rabo na GMT = 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)), kazalika da rashin kaskanci dangane da ƙimar seroconversion (SCR sama da 95% a cikin ƙungiyoyin jiyya) a makonni biyu bayan allurar rigakafi ta biyu (watau Ranar 43) a cikin manya masu shekaru 30 da haihuwa.
  • Amsoshin T-cell da aka bincika a cikin ƙaramin saiti na mahalarta sun nuna cewa VLA2001 ya haifar da fa'ida ta musamman antigen-takamaiman IFN-gamma wanda ke samar da T-sel masu aiki akan S- (74.3%), N- (45.9%) da M- (20.3%) furotin.

VLA2001 an yarda da shi sosai. Bayanin haƙuri na VLA2001 ya fi dacewa sosai idan aka kwatanta da allurar rigakafin mai aiki. Mahalarta shekaru 30 da tsufa sun ba da rahoton ƙarancin abubuwan da ake nema har zuwa kwana bakwai bayan allurar rigakafi, duka dangane da halayen rukunin allura (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001) da halayen tsarin (70.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001).

Ba a ba da rahoton abubuwan da ba a so ba da suka shafi jiyya (SAE). Kasa da 1% ya ba da rahoton wani mummunan lamari na sha'awa ta musamman a cikin kungiyoyin jiyya. Mahalarta a cikin ƙaramin shekaru masu allurar rigakafi tare da VLA2001 sun nuna bayanin martaba na gaba ɗaya kwatankwacin rukunin tsofaffi.

Abubuwan da suka faru na shari'o'in COVID-19 (ƙarshen binciken) sun kasance iri ɗaya tsakanin kungiyoyin jiyya. Cikakken rashin kowane lamuran COVID-19 mai ƙarfi na iya ba da shawarar cewa duka alluran rigakafin da aka yi amfani da su a cikin binciken sun hana COVID-19 mai ƙarfi wanda ke haifar da bambance-bambancen (s) da yawa (galibi Delta).

Adam Finn, Farfesa na Ilimin Yara, Jami'ar Bristol, Babban Mai Binciken Trial, ya ce: “Ƙananan matakan sake kunnawa da babban martani na ƙwayoyin cuta tare da martani mai yawa na T-cell da aka gani tare da wannan allurar rigakafin cutar gaba ɗaya duka abin burgewa ne da ƙarfafawa. Wannan wata hanya ce ta gargajiya don kera allurar riga -kafi fiye da alluran rigakafin da aka tura zuwa yanzu a Burtaniya, Turai, da Arewacin Amurka kuma waɗannan sakamakon sun nuna wannan ɗan takarar allurar rigakafin yana kan hanya don taka muhimmiyar rawa wajen shawo kan cutar. ”

Thomas Lingelbach, Babban Jami'in Valneva, ya ce: “Waɗannan sakamakon suna tabbatar da fa'idodin da ake dangantawa da alluran rigakafin ƙwayoyin cuta gaba ɗaya. Mun ƙuduri aniyar kawo ɗan takararmu na allurar rigakafi don lasisi cikin sauri kuma mu ci gaba da yin imani cewa za mu iya ba da gudummawa mai mahimmanci ga yaƙin duniya na yaƙi da cutar ta COVID-19. Muna da sha'awar ba da shawarar wani madadin maganin allurar rigakafin ga mutanen da har yanzu ba a yi musu allurar ba. ”

Juan Carlos Jaramillo, MD, Babban Jami'in Kula da Lafiya na Valneva, yayi sharhi: “Ina so in gode wa masu binciken shari’ar da duk mahalarta gwajin da masu haɗin gwiwa, musamman Cibiyar Nazarin Lafiya ta Ƙasa da ƙungiyoyin asibiti a cikin Cibiyoyin Bincike na NHS gami da Lafiya ta Jama’a Ingila. Wannan sakamakon yana nuna ƙimar haɗin gwiwar da muka fara a watan Satumbar 2020 kuma ba za mu iya cimma wannan muhimmin ci gaba ba tare da su. Za mu ci gaba da yin aiki sosai tare da MHRA don kammala ƙaddamar da ƙaddamarwar mu don amincewa. ”

Valneva ta fara ƙaddamar da ƙaddamarwa don amincewa da farko tare da Magungunan Magunguna da Hukumar Kula da Kayayyakin Kiwon Lafiya ta Burtaniya (MHRA) kuma tana shirin fara ƙaddamar da miƙawa don amincewa da sharaɗi tare da Hukumar Magunguna ta Turai. Ingancin gwaji na ƙarshe da MHRA ke buƙata don tabbatar da amincin bayanan VLA2001-301 yana ci gaba da gudana kuma shine abin buƙata don ƙaddamar da rahoton binciken asibiti.

A matsayin wani ɓangare na dabarun haɓaka samfuran, Valneva ya kammala ɗaukar masu aikin sa kai 306 masu shekaru 56 da haihuwa a New Zealand a cikin gwajin VLA2001-304 kuma yana tsammanin manyan bayanai a farkon 2022. Valneva ta kuma sanar da fara ɗaukar matasa a matsayin fadada gwajin Cov-Compare[2].

Kamfanin yana shirye-shirye don gwaji a cikin yara (shekaru 5-12) da Valneva da ke tallafawa gwajin gwaji don kimanta aikin ƙarfafawa na VLA2001 ga mutanen da ke buƙatar ƙarfafa.

Game da Mataki na 3 Cov-Compare (VLA2001-301)
Cov-Compare (VLA2001-301) bazuwar ne, makaho, makaho, sarrafawa, kwatankwacin gwajin rigakafin rigakafi a cikin manya 4,012 da matasa 660. Ƙarshen ƙarshen rigakafin rigakafin rigakafi shine fifikon rabo na GMT na VLA2001 idan aka kwatanta da AZD1222 (ChAdOx1-S) kazalika da rashin ƙima na matakan seroconversion na tsaka-tsakin rigakafin rigakafi da aka gudanar a cikin jadawalin rigakafin kashi biyu makonni huɗu baya, an auna su a sati biyu bayan allurar rigakafi ta biyu (watau Ranar 43) a cikin manya masu shekaru 30 da haihuwa. Hakanan yana kimanta aminci da juriya na VLA2001 a makonni biyu bayan allurar rigakafi ta biyu a cikin manya da matasa masu shekaru 12 da haihuwa. Ana gudanar da gwajin a shafuka 26 a duk faɗin Burtaniya mahalarta 2,972 masu shekaru 30 da haihuwa sun kasance bazuwar a cikin rabo na 2: 1 don karɓar allurai guda biyu na VLA2001 (n = 1,977) ko AZD1222 (ChAdOx1-S) (n = 995) a matakin shawarar da aka ba da shawarar, kwanaki 28 baya, a Ranaku 1 da 29. Don nazarin rigakafin rigakafi, samfurori daga mahalarta 990 (492 sun yi allurar VLA2001, 498 tare da AZD1222 (ChAdOx1-S)) waɗanda suka gwada sero-negative ga SARS- An bincika CoV-2 a kan nunawa. Mahalarta 1,040 waɗanda shekarunsu ba su kai 30 ba an ɗauke su aiki a cikin ƙungiyar ba da magani ba kuma sun karɓi VLA2001 kwanaki 28 baya. Ana yin nazarin bayanan aminci akan waɗancan mahalarta masu shekaru 18-29 masu shekaru a cikin daidaituwa ga manya masu shekaru 30 da sama. Kwanan nan, fitina ta fara rajistar mahalarta matasa na farko.

Bayani na VLA2001
VLA2001 a halin yanzu shine kawai ƙwayar cuta, mara aiki, ɗan takarar rigakafin adjuvant akan COVID-19 a gwajin asibiti a Turai. Anyi niyyar yin allurar rigakafin allurai masu haɗari don hana karusa da kamuwa da alamomi tare da COVID-19 yayin bala'in da ke ci gaba da yuwuwar daga baya don allurar rigakafi ta yau da kullun gami da magance sabbin bambance-bambancen. Hakanan VLA2001 na iya dacewa don haɓakawa, kamar yadda aka nuna allurar rigakafin maimaita aiki yana aiki da kyau tare da alluran rigakafin cutar gaba ɗaya. An samar da VLA2001 akan dandalin Vero-cell na Valneva, yana haɓaka fasahar kera don allurar encephalitis ta Japan mai lasisi na Valneva, IXIARO®. VLA2001 ya ƙunshi ƙwayoyin ƙwayoyin cuta marasa aiki na SARS-CoV-2 tare da ƙimar S-protein mai yawa, a haɗe tare da masu ba da shawara guda biyu, alum da CpG 1018. Wannan haɗin haɗin gwiwa yana ci gaba da haifar da matakan antibody mafi girma a cikin gwaje-gwaje na yau da kullun fiye da ƙirar alum-kawai da aka nuna motsi na martani na rigakafi zuwa Th1. CpG 1018 adjuvant, wanda Kamfanin Dynavax Technologies Corporation ya bayar (Nasdaq: DVAX), wani sashi ne na FDA- da HEPLISAV-B da EMA ta amince da su.®  allurar rigakafi. Tsarin masana'anta don VLA2001, wanda tuni an ɗaga shi zuwa sikelin masana'antu na ƙarshe, ya haɗa da rashin aikin sinadarai don adana tsarin asalin S-protein. Ana tsammanin VLA2001 zai dace da daidaitattun buƙatun sarkar sanyi (digiri 2 zuwa digiri 8 na Celsius).

Abubuwan da aka bayar na Valneva SE
Valneva kamfani ne na allurar rigakafi na musamman wanda aka mai da hankali kan haɓakawa da kasuwanci na allurar rigakafin cututtukan cututtukan da ke da mahimmancin buƙatun likita. Kamfanin yana ɗaukar ƙwararriyar ƙwaƙƙwaran niyya don haɓaka allurar rigakafin sannan yana amfani da zurfin fahimtar ilimin allurar rigakafi don haɓaka allurar rigakafin cutar da ke magance waɗannan cututtukan. Valneva ta ba da ƙwarewa da ƙwarewar duka don samun nasarar tallan alluran rigakafin guda biyu da haɓaka hanzarin ɗimbin masu neman allurar rigakafin cikin da ta cikin asibitin, gami da masu neman yaƙi da cutar Lyme, ƙwayar chikungunya da COVID-19.

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Juergen T Steinmetz

Juergen Thomas Steinmetz ya ci gaba da aiki a masana'antar tafiye-tafiye da yawon buɗe ido tun yana saurayi a Jamus (1977).
Ya kafa eTurboNews a cikin 1999 azaman wasiƙar farko ta yanar gizo don masana'antar yawon shakatawa ta duniya.

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