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Isitofu esitsha sesiZukulwana esilandelayo se-COVID-19

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I-Jiangsu Recbio Technology Co., Ltd. ("Recbio"), inkampani ye-biopharmaceutical egxile kuphando, uphuhliso kunye norhwebo lwezitofu zokugonya ezinokujongana nezifo ezixhaphakileyo ezinomthwalo obalulekileyo, namhlanje ibhengeze iziphumo ezilungileyo zokuqala ezivela kumntu wokuqala (FIH). ) uvavanyo lwe-ReCOV, isizukulwana esitsha, esiphinda sihlanganise amacandelo amabini e-COVID-19. Lilonke, idatha yokuqala ibonise ukuba i-ReCOV inyamezeleke kwaye yabonisa iprofayile yokhuseleko elungileyo. I-20μg ReCOV yenza i-titer ephezulu ye-anti-SARS-CoV-2 engathathi hlangothi ii-antibodies, kunye nenqanaba elithelekisekayo kunedatha epapashiweyo ngogonyo lwe-mRNA, iqikelela ukubakho okuthembisayo kwe-ReCOV ekuthinteleni izifo ezibangelwa yi-SARS-COV-2.

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"Sikhuthazwa lukhuseleko lokuqala kunye neprofayili ye-immunogenicity ye-ReCOV kolu lingo lwe-FIH," watsho uGqr. Liu Yong, uSihlalo kunye noMphathi Jikelele. Ugonyo lweProphylactic luseyeyona ndlela isebenzayo yokuthintela usulelo lwe-SARS-CoV-2 kunye nokulawula ubhubhane wehlabathi. Sijonge ukubonelela ngesizukulwana esilandelayo sesitofu sokugonya i-COVID-19 esinokubakho kukhuseleko, ukusebenza kakuhle kunye nokufikeleleka, kwaye siza kuqhubela phambili i-ReCOV kwizifundo ezinkulu zeklinikhi kungekudala ukuze sivavanye ukusebenza kwayo kunye nokhuseleko.

Olu lingo lwe-FIH oluqhubekayo luphononongo olungenamkhethe, oluyimfama oluphindwe kabini, olulawulwa yi-placebo ukuhlola ukhuseleko, i-reactogenicity, kunye ne-immunogenicity ye-2 yokunyuka kweedosi ze-ReCOV, xa ilawulwa njenge-2 intramuscular injections (kunye neentsuku ezingama-21 ngaphandle) kwizifundo eziphilileyo. Namhlanje i-Recbio inike ingxelo yedatha engaphelelanga yokhuseleko, i-reactogenicity kunye ne-immunogenicity yeQela loku-1 (abadala abancinci/ReCOV 20μg).

Eli qela libhalise abathathi-nxaxheba abangama-25 abaneminyaka eli-18 ukuya kuma-55 ubudala. Kulingo, i-SARS-Cov-2-neutralizing antibody geometric mean titers (GMTs) yaguqulelwa ekubeni yi-WHO/NIBSC iyunithi ye-IU/mL ukuze kuthelekiswe ii-antibody titers kunye nezo zezinye izitofu ezisetyenziswa ngokubanzi. I-Recbio ifumene i-GMTs ye-1643.2 IU/mL yokunciphisa izilwa-buhlungu kwiintsuku ezili-14 emva kweedosi ezimbini ze-ReCOV, kunye nezinga le-seropositive (SPR) kunye nesantya se-seroconversion (SCR) njenge-100%, ecebisa ukusebenza okuthembisayo kwe-ReCOV ekuthinteleni i-SARS-COV-2. izifo ezithathelwanayo. Izilwa-buhlungu ze-SARS-CoV-2 zenziwa yilabhoratri esembindini yophononongo (360Biolabs). Ngokophononongo lwakutsha nje loshicilelo1, i-GMT ye-SARSCoV-2 yokungathathi hlangothi izithinteli-zifo yayiyi-1404.16 IU/mL kunye ne-928.75 IU/mL kwiintsuku ezili-14 emva kweedosi ezimbini zezitofu zokugonya zeModerna kunye ne-BioNTech/Pfizer mRNA, ngokulandelelanayo.

Ngokucacileyo, ngokusekwe kwiplasma yabantu edityanisiweyo esuka kwizigulane ezibuyelayo, umgangatho wehlabathi we-WHO (kubandakanywa ne-20/136, enikwe yiNational Institute for Biological Standards and Control [NIBSC]) yayisetyenziswa ngokubanzi ukulinganisa iindlela ezahlukeneyo zokuxilonga.

Ngeli xesha, idatha ye-cellular immunogenicity ibonise ukuba i-ReCOV inokuvelisa iimpendulo ze-antigen-specific CD4+ T kubantu abadala abancinci, ebonisa kwi-IFN-γ kunye ne-IL-2 yemveliso, intsingiselo ecacileyo malunga ne-Th1 phenotype yabonwa kunye nenqanaba eliphezulu le-cytokines ye-Th1 echongiwe. Usuku lwe-36 (iintsuku ezili-14 emva kokugonywa kwe-2).

I-ReCOV yayinyamezeleke ngokubanzi ngokhuseleko olulungileyo kunye neprofayili enyamezelekayo. Uninzi lweziganeko ezimbi zazinobunzulu obuncinane. Ayikho i-SAE okanye i-TEAE ekhokelela ekuyekweni kwangoko, akukho zimpawu zibalulekileyo ezingaqhelekanga/ziphumo zovavanyo lwaselabhoratri ezinokubaluleka kwezonyango.

I-Recbio iphuhlise amaqonga etekhnoloji amathathu aphambili kuphuhliso lwenoveli ye-adjuvant, ubunjineli beprotheyini kunye novavanyo lwe-immunoloji. Ixhaswa ngala maqonga, i-Recbio iyaqhubeka ifumanisa kwaye iphuhlisa uluhlu olupheleleyo lwabagqatswa bogonyo, abafana nesizukulwana esilandelayo se-HPV, ishingles kunye nogonyo loMkhuhlane.

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umhleli

Umhleli oyintloko nguLinda Hohnholz.

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1 Comment

  • Linda mama,
    Awuyi kucinga ukuba inqaku lakho linika ithemba kangakanani kubantu abafana nam nelizwe lam, elikwelinye icala lehlabathi. Silahlekelwe lithemba ngokupheleleyo malunga nokuba siza kuphuma etoneleni malunga nobhubhani we-Covid. Linda maam, awukho ngaphantsi kwesithunywa sikaThixo. UThixo ugcina wena, usapho lwakho kunye nelizwe lakho nikhuselekile.