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Kafukufuku Woyamba mwa Anthu Wofuna Katemera Watsopano wa COVID-19

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Written by Alireza

Mbiri yololeredwa bwino komanso yabwino yachitetezo, palibe SAE kapena TEAE yomwe imatsogolera kusimitsidwa koyambirira, palibe zizindikiro zachilendo / zotsatira zoyesa zalabu zokhala ndi tanthauzo lachipatala.

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  • 20μg ReCOV idapangitsa kuti ma anti-SARS-CoV-2 azitha kusintha ma antibodies, okhala ndi mulingo wofananirako kuposa zomwe zidasindikizidwa ndi katemera wa mRNA, kulosera zamphamvu zodalirika za ReCOV popewa matenda oyambitsidwa ndi SARS-COV-2.
  • ReCOV idzawunikidwanso kuti iwonetsetse kuti ndi yothandiza komanso yotetezeka m'mayesero akuluakulu azachipatala posachedwa

Jiangsu Recbio Technology Co., Ltd. ("Recbio"), kampani ya biopharmaceutical yomwe ikuyang'ana kwambiri kafukufuku, chitukuko ndi malonda a katemera wamakono omwe angathe kuthana ndi matenda omwe ali ndi katundu wambiri, lero alengeza zotsatira zabwino zoyambirira kuchokera kwa anthu oyambirira (FIH). ) kuyesa kwa ReCOV, katemera wa m'badwo watsopano, wophatikizanso zigawo ziwiri za COVID-19 subunit. Ponseponse, zoyambira zidawonetsa kuti ReCOV idalekerera bwino komanso ikuwonetsa mbiri yabwino yachitetezo. 20μg ReCOV idapangitsa kuti ma antibodies a anti-SARS-CoV-2 asasokonezeke, okhala ndi mulingo wofananirako kuposa zomwe zidasindikizidwa ndi katemera wa mRNA, kulosera za kuthekera kwa ReCOV popewa matenda oyambitsidwa ndi SARS-COV-2.

"Tili olimbikitsidwa ndi mbiri yoyambirira ya chitetezo ndi chitetezo cha mthupi cha ReCOV muyeso la FIH," adatero Dr. Liu Yong, Wapampando ndi General Manager. "Katemera wa Prophylactic akadali njira yabwino kwambiri yopewera matenda a SARS-CoV-2 ndikuwongolera mliri wapadziko lonse lapansi. Tikuyembekeza kupereka m'badwo wotsatira wa katemera wa COVID-19 wokhala ndi chitetezo, kuchita bwino komanso kupezeka, ndipo tipititsa patsogolo ReCOV m'maphunziro akulu azachipatala posachedwa kuti tiwone ngati akugwira ntchito komanso chitetezo chake. ”

Kuyesa kwa FIH komwe kukuchitika kumeneku ndi kafukufuku wopangidwa mwachisawawa, wakhungu pawiri, woyendetsedwa ndi placebo kuti awunike chitetezo, reactogenicity, ndi immunogenicity ya 2 yokwera ya Mlingo wa ReCOV, ikaperekedwa ngati ma jakisoni awiri a intramuscular (osiyana masiku 2) mwa anthu athanzi. Lero Recbio adanenanso zachitetezo chosadziwika bwino, reactogenicity ndi immunogenicity ya Gulu 21 (akuluakulu/ReCOV 1μg).

Gululi linalembetsa anthu 25 omwe anali azaka 18 mpaka 55 zakubadwa. Muyeso, ma SARS-Cov-2-neutralizing antibody geometric mean titers (GMTs) adasinthidwa kukhala WHO/NIBSC unit ya IU/mL poyerekeza kuletsa ma antibody titers ndi akatemera ena omwe amagwiritsidwa ntchito kwambiri. Recbio adapeza ma GMTs a 1643.2 IU/mL pochepetsa ma antibodies pamasiku 14 pambuyo pa Mlingo iwiri ya ReCOV, yokhala ndi seropositive rate (SPR) ndi seroconversion rate (SCR) ngati 100%, kutanthauza mphamvu yodalirika ya ReCOV popewa SARS-COV-2. matenda oyambitsidwa. Ma antibodies a SARS-CoV-2 adachitidwa ndi labotale yapakati ya kafukufukuyu (360Biolabs). Malinga ndi kafukufuku waposachedwa wa pre-print1, GMT ya SARSCoV-2 neutralizing antibodies inali 1404.16 IU/mL ndi 928.75 IU/mL patatha masiku 14 pambuyo pa Mlingo iwiri ya katemera wa Moderna ndi BioNTech/Pfizer mRNA, motsatana.

Makamaka, kutengera plasma yamunthu yophatikizidwa kuchokera kwa odwala omwe ali ndi vuto, muyezo wapadziko lonse wa WHO (kuphatikiza 20/136, woperekedwa ndi National Institute for Biological Standards and Control [NIBSC]) idagwiritsidwa ntchito kwambiri poyesa njira zosiyanasiyana zowunikira.

Pakadali pano, kuchuluka kwa ma cell immunogenicity kunawonetsa kuti ReCOV imatha kuyambitsa ma cell a CD4+ T mwa achikulire achichepere, kuwonetsa mu IFN-γ ndi IL-2 kupanga, zomwe zimawonekera ku Th1 phenotype zidawonedwa ndi kuchuluka kwa ma cytokines a Th1 omwe adapezeka. Tsiku 36 (masiku 14 pambuyo katemera 2).

ReCOV nthawi zambiri imaloledwa bwino ndi mbiri yabwino yotetezedwa komanso yolekerera. Zowopsa zambiri zinali zocheperako. Palibe SAE kapena TEAE yomwe imatsogolera kusimidwa koyambirira, palibe zizindikiro zachilendo / zoyeserera za labotale zomwe zili ndi tanthauzo lachipatala.

Recbio adapanga nsanja zitatu zaukadaulo zapamwamba kwambiri zachitukuko chatsopano cha adjuvant, uinjiniya wa mapuloteni ndi kuwunika kwa immunological. Mothandizidwa ndi nsanja izi, Recbio akupitilizabe kupeza ndi kupanga gulu lathunthu la anthu ofuna katemera, monga a m'badwo wotsatira wa HPV, shingles ndi katemera wa Flu.

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