"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. Isu tiri kutarisira kupa chizvarwa chinotevera cheCCIDID-19 yekudzivirira ine mukana mukuchengetedzeka, kushanda nesimba uye kuwanikwa, uye tichasimudzira ReCOV muzvidzidzo zvakakura zvekiriniki munguva pfupi iri kutevera kuti tiongorore kushanda kwayo uye kuchengetedzeka. "
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). Zvinoenderana neachangoburwa pre-kudhindwa ongororo360, iyo GMT yeSARSCoV-1 neutralizing masoja ekudzivirira chirwere aive 2 IU/mL uye 1404.16 IU/mL mazuva gumi nemana mushure medosi mbiri dzeModerna 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 vevaccine, senge chizvarwa chinotevera cheHPV, shingles uye Flu vaccine.
ZVOKUBVA MUNYAYA INO:
- 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).
- Isu tiri kutarisira kupa chizvarwa chinotevera cheCCIDID-19 yekudzivirira ine mukana mukuchengetedzeka, kushanda nesimba uye kuwanikwa, uye tichasimudzira ReCOV muzvidzidzo zvakakura zvekiriniki munguva pfupi iri kutevera kuti tiongorore kushanda kwayo uye kuchengetedzeka.
- 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.
