"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.
INTO ONOKUYITHATHA KWELI NQAKU:
- 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).
- We are looking forward to providing a next-generation of COVID-19 vaccine with the potential in safety, efficacy and accessibility, and will advance ReCOV into larger clinical studies soon to evaluate its efficacy and safety.
- This ongoing FIH trial is a randomized, double-blinded, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 2 ascending doses of ReCOV, when administered as 2 intramuscular injections (with 21 days apart) in healthy subjects.
