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Nazari Na Farko Cikin Mutum Na Sabon Dan Takarar Alurar COVID-19

Tambarin Recbio
Written by Dmytro Makarov

Kyakkyawan jurewa da ingantaccen bayanin martaba, babu SAE ko TEAE da ke haifar da katsewa da wuri, babu alamun mahimmanci masu mahimmanci / sakamakon gwajin gwaji tare da mahimmancin asibiti.

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  • 20μg ReCOV ya haifar da babban titer na anti-SARS-CoV-2 na kawar da ƙwayoyin rigakafi, tare da aƙalla matakin kwatankwacin fiye da bayanan da aka buga tare da rigakafin mRNA, yana hasashen ingantaccen ingancin ReCOV don hana cututtukan da ke haifar da SARS-COV-2.
  • Za a ƙara kimanta ReCOV don inganci da aminci a cikin manyan gwaje-gwajen asibiti nan ba da jimawa ba

Jiangsu Recbio Technology Co., Ltd. ("Recbio"), wani kamfani na biopharmaceutical da ke mai da hankali kan bincike, haɓakawa da kuma tallata sabbin alluran rigakafin da za su iya magance cututtuka masu yawa tare da nauyi mai nauyi, a yau ya sanar da sakamako na farko na farko daga mutum na farko (FIH) ) Gwajin ReCOV, sabon-tsara, mai sake haɗe-haɗe-haɗe-haɗe-haɗe-haɗe-haɗe-haɗe-haɗe-halayen COVID-19. Gabaɗaya, bayanan farko sun nuna cewa an yi haƙuri da ReCOV da kyau kuma sun nuna kyakkyawan bayanin martaba. 20μg ReCOV ya haifar da babban titer na anti-SARS-CoV-2 na kawar da ƙwayoyin rigakafi, tare da aƙalla matakin kwatankwacin fiye da bayanan da aka buga tare da rigakafin mRNA, yana hasashen yuwuwar yuwuwar ReCOV don hana cututtukan da ke haifar da SARS-COV-2.

"Muna samun ƙarfafawa ta hanyar aminci na farko da bayanan rigakafi na ReCOV a cikin wannan gwaji na FIH," in ji Dokta Liu Yong, Shugaba da Babban Manajan. "Ayyukan rigakafin rigakafi har yanzu sune hanyoyin da suka fi dacewa don hana kamuwa da cutar SARS-CoV-2 da sarrafa cutar ta duniya. Muna sa ran samar da wani ƙarni na gaba na rigakafin COVID-19 tare da yuwuwar a cikin aminci, inganci da samun dama, kuma za mu haɓaka ReCOV cikin manyan karatun asibiti nan ba da jimawa ba don kimanta ingancinsa da amincinsa."

Wannan gwaji na FIH mai gudana shine bazuwar, makafi biyu, nazarin sarrafa wuribo don kimanta aminci, amsawa, da rigakafi na 2 hawan allurai na ReCOV, lokacin da aka gudanar da alluran intramuscular 2 (tare da kwanaki 21 baya) a cikin batutuwa masu lafiya. A yau Recbio ya ba da rahoton ɓoyayyiyar bayanan da ba a rufe ba na aminci, amsawa da rigakafi ga ƙungiyar 1 (ƙananan manya/ReCOV 20μg).

Wannan ƙungiyar ta yi rajistar mahalarta 25 waɗanda ke da shekaru 18 zuwa 55. A cikin gwajin, SARS-Cov-2-neutralizing antibody geometric mean titers (GMTs) an canza su zuwa sashin WHO/NIBSC na IU/mL don kwatankwacin kawar da titers antibody tare da na sauran alluran rigakafin da ake amfani da su sosai. Recbio ya sami GMTs na 1643.2 IU/ml don kawar da ƙwayoyin rigakafi a cikin kwanaki 14 bayan allurai biyu na ReCOV, tare da ƙimar seropositive (SPR) da ƙimar seroconversion (SCR) a matsayin 100%, yana ba da shawarar ingantaccen tasirin ReCOV don hana SARS-COV-2 jawo cututtuka. SARS-CoV-2 antibodies an yi su ta tsakiyar dakin gwaje-gwaje na binciken (360Biolabs). A cewar wani binciken da aka yi kafin bugu na baya-bayan nan1, GMT na SARSCoV-2 neutralizing antibodies kasance 1404.16 IU/ml da 928.75 IU/ml kwanaki 14 bayan allurai biyu na Moderna da BioNTech/Pfizer mRNA alluran rigakafi, bi da bi.

Musamman ma, dangane da haɗe-haɗen plasma na ɗan adam daga marasa lafiya, ma'aunin duniya na WHO (ciki har da 20/136, wanda Cibiyar Kula da Ka'idodin Halittu ta Ƙasa ta bayar (NIBSC)) an yi amfani da shi sosai don daidaita dabarun bincike daban-daban.

A halin yanzu, bayanan immunogenicity na salon salula sun nuna cewa ReCOV na iya haifar da takamaiman CD4 + T cell martani a cikin matasa matasa, yana nunawa a cikin samar da IFN-γ da IL-2, an lura da wani yanayi na zahiri ga Th1 phenotype tare da matakin kololuwar cytokines Th1 da aka gano a Ranar 36 (kwanaki 14 bayan alurar riga kafi na biyu).

ReCOV gabaɗaya an jure shi da kyau tare da ingantaccen bayanin martaba da aminci. Yawancin abubuwan da ba su da kyau sun kasance masu sauƙi a cikin tsanani. Babu SAE ko TEAE da ke haifar da dakatarwa da wuri, babu alamun mahimmanci masu mahimmanci / sakamakon gwajin dakin gwaje-gwaje tare da mahimmancin asibiti.

Recbio ya haɓaka dandamalin fasaha na yanke-yanke-baki guda uku don ci gaba na gabaɗaya, injiniyan furotin da ƙimar rigakafi. Tallafawa daga waɗannan dandamali, Recbio ya ci gaba da ganowa da haɓaka cikakken rukunin ƙwararrun ƴan takarar rigakafin, kamar su na gaba na HPV, shingles da rigakafin mura.

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Dmytro Makarov

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