Ucwaningo Lokuqala Kubantu Lomuntu Okhethiwe Wokugomela I-COVID-19

• I-20μg ReCOV yenza i-titer ephezulu yamasosha omzimba alwa ne-SARS-CoV-2, anezinga okungenani eliqhathanisekayo kunedatha eshicilelwe enemigomo ye-mRNA, ebikezela ukusebenza okuthembisayo kwe-ReCOV ekuvimbeleni izifo ezibangelwa yi-SARS-COV-2
• I-ReCOV izophinde ihlolwe ukusebenza kahle nokuphepha ezivivinyweni zomtholampilo ezinkulu maduze

I-Jiangsu Recbio Technology Co., Ltd. (“Recbio”), inkampani ye-biopharmaceutical egxile ocwaningweni, ekuthuthukisweni nasekudayiseni imithi yokugoma emisha engabhekana nezifo ezidlangile ezinomthwalo obalulekile, namuhla imemezele imiphumela emihle yokuqala evela kumuntu wokuqala (FIH). ) ukuhlolwa kwe-ReCOV, isizukulwane esisha, umuthi wokugomela izingxenye ezimbili ze-COVID-19. Sekukonke, idatha yokuqala ibonise ukuthi i-ReCOV yabekezelelwa kahle futhi yabonisa iphrofayili enhle yokuphepha. I-20μg ReCOV yenza i-titer ephezulu yamasosha omzimba alwa ne-SARS-CoV-2, enezinga okungenani eliqhathanisekayo kunedatha eshicilelwe enemigomo ye-mRNA, ebikezela amandla athembisayo e-ReCOV ekuvimbeleni izifo ezibangelwa yi-SARS-COV-2.

"Sikhuthazwa ukuphepha kokuqala kanye nephrofayili ye-immunogenicity ye-ReCOV kulolu cwaningo lwe-FIH," kusho uDkt. Liu Yong, uSihlalo kanye noMphathi Jikelele. “Imithi yokugomela i-prophylactic iseyizindlela eziphumelela kakhulu zokuvikela ukutheleleka kwe-SARS-CoV-2 nokulawula ubhubhane lomhlaba wonke. Sibheke ngabomvu ukuhlinzeka ngesizukulwane esilandelayo somgomo we-COVID-19 onamandla okuphepha, ukusebenza kahle nokufinyeleleka, futhi sizoqhubekisela phambili i-ReCOV ezifundweni zomtholampilo ezinkulu maduze ukuze sihlole ukusebenza nokuphepha kwayo.”

Lolu cwaningo oluqhubekayo lwe-FIH luwucwaningo olulawulwa ngokungahleliwe, oluphuphutheke kabili, olulawulwa yi-placebo ukuze kuhlolwe ukuphepha, i-reactogenicity, kanye nokuzivikela komzimba kwemithamo emi-2 ekhuphukayo ye-ReCOV, lapho isetshenziswa njengemijovo emi-2 ye-intramuscular (ehlukaniswe izinsuku ezingama-21) ezifundweni ezinempilo. Namuhla i-Recbio ibike idatha engaphuphutheki ngokwengxenye yokuphepha, i-reactogenicity kanye ne-immunogenicity yeQembu 1 (abadala abasebasha/ReCOV 20μg).

Leli qembu libhalise ababambiqhaza abangu-25 abaneminyaka engu-18 kuya kwengu-55 ubudala. Ocwaningweni, i-SARS-Cov-2-neutralizing antibody geometric mean titers (GMTs) yaguqulelwa kuyunithi ye-WHO/NIBSC ye-IU/mL ukuze kuqhathaniswe nokuncishiswa kwe-antibody titers naleyo yeminye imigomo esetshenziswa kakhulu. U-Recbio uthole ama-GMTs angu-1643.2 IU/mL wokunciphisa amasosha omzimba ezinsukwini eziyi-14 ngemva kwemithamo emibili ye-ReCOV, nakho kokubili izinga le-seropositive (SPR) kanye ne-seroconversion rate (SCR) njengo-100%, okuphakamisa ukusebenza okuthembisayo kwe-ReCOV ekuvimbeleni i-SARS-COV-2. izifo ezithathelwanayo. Amasosha omzimba e-SARS-CoV-2 awenza angathathi hlangothi enziwe ilabhorethri emaphakathi yocwaningo (360Biolabs). Ngokocwaningo lwakamuva lwangaphambi kokuphrinta¹, i-GMT ye-SARSCoV-2 amasosha omzimba angathathi hlangothi yayiyi-1404.16 IU/mL kanye ne-928.75 IU/mL izinsuku eziyi-14 ngemuva kwemithamo emibili yemigomo ye-Moderna ne-BioNTech/Pfizer mRNA, ngokulandelana.

Ngokuphawulekayo, ngokusekelwe ku-plasma yomuntu ehlanganisiwe evela ezigulini ezilulama, indinganiso yamazwe ngamazwe ye-WHO (kuhlanganise ne-20/136, ehlinzekwe yi-National Institute for Biological Standards and Control [NIBSC]) yasetshenziswa kabanzi ukuze kulinganiswe amasu okuxilonga ahlukene.

Ngaleso sikhathi, idatha ye-cell immunogenicity ibonise ukuthi i-ReCOV ingadala izimpendulo ze-antigen-specific CD4+ T cell kubantu abadala abasebasha, okubonisa ukukhiqizwa kwe-IFN-γ kanye ne-IL-2, ukuthambekela okusobala kwe-Th1 phenotype kwabonwa ngezinga eliphakeme lama-cytokines e-Th1 atholakele Usuku lwama-36 (izinsuku eziyi-14 ngemuva kokugoma kwesi-2).

I-ReCOV ngokuvamile yayibekezelelwa kahle ngokuphepha okuhle nokubekezeleleka kwephrofayela. Iningi lezehlakalo ezingezinhle bezinobunzima obuncane. Azikho i-SAE noma i-TEAE eholela ekuyekisweni kusenesikhathi, azikho izimpawu ezibalulekile ezingajwayelekile/imiphumela yokuhlolwa kwaselabhorethri enokubaluleka komtholampilo.

U-Recbio uthuthukise izinkundla zobuchwepheshe ezintathu ezisezingeni eliphezulu zokuthuthukiswa kwe-adjuvant inoveli, ubunjiniyela bamaprotheni kanye nokuhlola amasosha omzimba. Isekelwa yilezi zinkundla, i-Recbio iyaqhubeka nokuthola nokuthuthukisa uhlu oluphelele lwabantu abasha bokugoma, njengemithi yokugomela i-HPV yesizukulwane esilandelayo, i-shingles kanye ne-Flu.