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Chekutanga-mu-Munhu Chidzidzo cheMutsva weCOVID-19 Mumiriri

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rakanyorwa Dmytro Makarov

Yakatenderwa zvakanaka uye yakanaka chengetedzo mbiri, hapana SAE kana TEAE inotungamira mukuregedzwa kwekutanga, hapana zviratidzo zvakakosha / mhedzisiro yekuongororwa murabhoritari ine kukosha kwekiriniki.

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  • 20μg ReCOV yakakonzera yakakwira titer ye-anti-SARS-CoV-2 inodzivirira masoja ekudzivirira chirwere, aine kanenge nhanho inoenzana pane yakaburitswa data ine mRNA vaccin, ichifanotaura kushanda kwakavimbisa kweReCOV mukudzivirira zvirwere zvinokonzerwa neSARS-COV-2.
  • ReCOV ichazoongororwazve kushanda uye kuchengetedzeka mumiyedzo mikuru yekiriniki munguva pfupi iri kutevera

Jiangsu Recbio Technology Co., Ltd. ("Recbio"), kambani yebiopharmaceutical inotarisa mukutsvagisa, kusimudzira uye kutengeserana kwemishonga yekudzivirira inogona kugadzirisa zvirwere zvakapararira nemutoro wakakura, nhasi yazivisa mhedzisiro yakanaka yekutanga-mu-munhu (FIH). ) kuyedzwa kweReCOV, chizvarwa chitsva, chinosanganisa maviri-chikamu COVID-19 subunit vaccine. Pakazere, iyo yekutanga data yakaratidza kuti ReCOV yakatenderwa zvakanaka uye yakaratidza yakanaka kuchengetedza chimiro. 20μg ReCOV yakakonzera yakakwira titer ye-anti-SARS-CoV-2 inodzivirira masoja ekudzivirira chirwere, ine nhanho inoenzana pane yakaburitswa data nemishonga yekudzivirira mRNA, ichifanotaura mukana unovimbisa weReCOV mukudzivirira zvirwere zvinokonzerwa neSARS-COV-2.

"Tinokurudzirwa nekutanga kuchengetedza uye immunogenicity profile yeReCOV muyedzo iyi yeFIH," akadaro Dr. Liu Yong, Sachigaro uye General Manager. "Prophylactic vaccine ichiri nzira inoshanda yekudzivirira hutachiona hweSARS-CoV-2 uye kudzora denda repasi rose. Tiri kutarisira kupa chizvarwa chinotevera chekudzivirira kweCCIDID-19 nekugona mukuchengetedza, kushanda uye kuwanikwa, uye tichasimudzira ReCOV muzvidzidzo zvakakura zvekiriniki munguva pfupi iri kutevera kuti tiongorore kushanda kwayo uye kuchengeteka. "

Uyu muyedzo urikuenderera mberi weFIH chidzidzo chisina kurongeka, chakapofumadzwa kaviri, chinodzorwa neplacebo kuti chiongorore kuchengetedzwa, reactogenicity, uye immunogenicity ye2 inokwira madosi eReCOV, kana ichiitwa se2 majekiseni emumuscular (akaparadzana mazuva makumi maviri nerimwe) muzvidzidzo zvine hutano. Nhasi Recbio yakataura chikamu chisina kuvharwa data chekuchengetedza, reactogenicity uye immunogenicity yeCohort 21 (vadiki vakuru/ReCOV 1μg).

Boka iri rakanyoresa vatori vechikamu 25 vaive nemakore 18 kusvika ku55 ezera. Mukutongwa, iyo SARS-Cov-2-neutralizing antibody geometric mean titers (GMTs) yakashandurwa kuita WHO/NIBSC unit yeIU/mL kuti ienzaniswe nekuita neutralizing antibody titers nemamwe emamwe majekiseni anoshandiswa zvakanyanya. Recbio akawana maGMTs e1643.2 IU/mL yekumisa masoja ekudzivirira chirwere pamazuva gumi nemana mushure memadosi maviri eReCOV, aine ese seropositive rate (SPR) uye seroconversion rate (SCR) se14%, zvichiratidza kushanda kunovimbisa kweReCOV mukudzivirira SARS-COV-100. zvinokonzerwa nezvirwere. SARS-CoV-2 neutralizing masoja ekudzivirira chirwere akaitwa nepakati marabhoritari yechidzidzo (2Biolabs). Maererano neazvino pre-print study1, iyo GMT yeSARSCoV-2 neutralizing masoja ekudzivirira chirwere aive 1404.16 IU/mL uye 928.75 IU/mL mazuva gumi nemana mushure medosi miviri yemishonga yekudzivirira yeModerna neBioNTech/Pfizer mRNA, zvichiteerana.

Zvinonzwisisika, zvichibva paplasma yevanhu yakabatanidzwa kubva kuvarwere vanopora, WHO international standard (kusanganisira 20/136, yakapiwa neNational Institute for Biological Standards and Control [NIBSC]) yakashandiswa zvakanyanya kugadzirisa nzira dzakasiyana dzekuongorora.

Zvichakadaro, iyo cellular immunogenicity data yakaratidza kuti ReCOV inogona kukonzera antigen-chaiyo CD4+ T cell mhinduro muvakuru vechidiki, zvichiratidzira muIFN-γ uye IL-2 kugadzirwa, maitiro ari pachena akananga kuT1 phenotype akaonekwa aine huwandu hwepamusoro hweT1 cytokines yakaonekwa panguva. Zuva 36 (mazuva gumi nemana mushure mekudzivirira kwechipiri).

ReCOV yaiwanzo bvumidzwa nekuchengetedza kwakanaka uye kushivirira chimiro. Zvizhinji zvezviitiko zvakashata zvaive zvinyoro mukuomarara. Hapana SAE kana TEAE inotungamira mukuregedzwa kwekutanga, hapana zviratidzo zvakakosha / mhedzisiro yekuongororwa murabhoritari ine kukosha kwekiriniki.

Recbio yakagadzira matatu ekucheka-kumucheto tekinoroji mapuratifomu einoveli adjuvant budiriro, protein engineering uye immunological evaluation. Ichitsigirwa nemapuratifomu aya, Recbio inoenderera mberi nekutsvaga nekugadzira sutu izere yevanoda vaccine vaccine, senge chizvarwa chinotevera cheHPV, shingles uye Flu vaccine.

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Nezvomunyori

Dmytro Makarov

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