Umuthi wokugomela we-CanSinoBIO ohogele i-COVID-19 uhlinzeka ngezinzuzo ezihlukile futhi umele isixazululo esisha ekuphenduleni ubhubhane lwe-COVID-19. Ukwelashwa okungenanalithi, okungahlanyisi kuhlose ukuhlinzeka ngokuvikeleka okusheshayo, okujwayelekile kanye nesilinganiso esikhulu ngokuphatha okulula. Umuthi wokugoma ohogeliwe uqeqesha umsebenzi wenkumbulo yokuzivikela komzimba ngokulingisa ukutheleleka kwemvelo kwegciwane, okungagcini nje ngokuvuselela ukuvikeleka kwe-humoral kanye namaselula, kodwa futhi kubangele ngempumelelo ukuzivikela kwe-mucosal ukuze kuzuze ukuvikelwa okuphindwe kathathu, okuphelele.
Ucwaningo lubonise ukuthi ukukhulisa umgomo ongasebenzi nge-Inhalation Convidecia™ kuvuselela ukusabela okuqinile kokuzivikela komzimba ku-mucosal. Izinga le-RBD-specific IgA-binding antibody latholwa ku-serum yezifundo ezinsukwini eziyi-14 ngemuva kokugoma.
Uhlolojikelele Lwezifundo Zomtholampilo
Ucwaningo lwaluhlelwe ngokungahleliwe, lungaboni futhi lulawulwa ngokufanayo, nabahlanganyeli be-420 babelwa ngokungahleliwe kumaqembu amathathu abantu abangu-140. Iqembu elilodwa lathola umthamo owodwa ophansi (0.1 ml) we-Inhalation Convidecia™iqembu elilodwa lathola umthamo owodwa ophezulu (0.2 ml) womgomo ohogeliwe; futhi iqembu lokugcina lithole umuthi wokugoma owawungacushiwe olawulwa ngomjovo ofakwa emisipha. Ucwaningo lubonise ukuphepha kanye nokuzivikela komzimba kwe-Inhalation Convidecia™ njengesithuthukisi kusetshenziswa kuphela umthamo owodwa wesihlanu noma okubili kwesihlanu kwenguqulo yayo ye-intramuscular.
Ukuphepha Okufakazelwe kanye Nempumelelo Komuthi Wokugoma Wokuhogela we-CanSinoBIO
Idatha yemiphumela yokuphepha ibonise ukuthi kube nezigameko ezimbalwa zezehlakalo ezimbi ngemva kwe-heterologous booster ye-Inhalation Convidecia™ kunalezo ezinikezwe isikhuthazi se-homologous somuthi wokugoma ongacushiwe. Azikho izehlakalo ezimbi ezimbi ezibonwe emaqenjini amabili okuhogela umoya ezinsukwini ezingama-28 ngemuva kokusetshenziswa kwe-booster, futhi kwakungekho mibiko yokungalungi kokusebenza kwamaphaphu okubalulekile emtholampilo.
Idatha ye-immunogenicity ibonise ukuthi i-booster ehogeliwe ye-heterologous iveze izinga eliphezulu kakhulu lamasosha omzimba angathathi hlangothi kunalawo ane-booster efanayo yomuthi wokugoma ongacushiwe. Kwakungekho mehluko obalulekile ekuphenduleni kokuzivikela komzimba phakathi kwamaqembu amabili okuhogela, ayephakeme izikhathi ezingu-6.7 kuya kwezingu-10.7 kunalelo elibonwe eqenjini lesithathu eline-booster ye-homologous phakathi kwezinsuku eziyi-14 nezingu-28 ngemva kokudubula kwe-booster. Ukwengeza, izinga lama-antibodies angathathi hlangothi likhuphuke ngosuku lwe-28 ngemuva kwe-booster ephefumulayo ku-6054.1 (95% CI 4584.1, 7995.0) yeqembu le-dose ephansi kanye ne-4221.3 (2976.9, 5985.3) IU / ml yeqembu le-high-dose. Iphinde yabonisa ukuthi i-Inhalation Convidecia™ inikeze izinga eliphezulu lokuvikela okuphambanayo ngokumelene nokwahluka kwe-Delta, okunamazinga aphezulu amasosha omzimba anciphisa amandla atholakala kunaleyo ngemithi yokugoma engacushiwe.
Uma kuqhathaniswa ne-booster engasebenzi, inyuke kakhulu i-2019-nCoV spike protein-specific IFN-γ kanye ne-IL-2 ELISA ingatholwa ezinsukwini eziyi-7 ngemuva kwe-inhalation booster. Izinga lenkulumo le-INF-γ ne-IL-2 eqenjini le-inhalation booster laliyizikhathi eziyisi-6 kuye kweziyi-10 futhi izikhathi ezi-4 kuye kwezingu-5 ukuphakama kunalawo aseqenjini le-booster elingacushiwe, ngokulandelana. Kubonisa ukuthi uma kuqhathaniswa ne-homologous booster engasebenzi yomgomo, i-heterologous booster ehogeliwe ingaheha ngokuphawulekayo impendulo yokuzivikela yeselula yohlobo lwe-Th1, kuyilapho izici ezifana nobulili neminyaka zingenawo umthelela ekuphenduleni kokuzivikela komzimba kweselula.
Ukwengeza, izinga le-RBD-specific ELISA antibody elitholwe i-heterologous booster ehogeliwe laliphezulu kakhulu kunalelo lomuthi wokugoma ongacushiwe we-homologous booster ezinsukwini ezingama-28 ngemuva kokuphathwa, izinga le-RBD antibody eqenjini lokuhogela lomthamo omncane lalicishe libe izikhathi eziyi-13 kunalelo iqembu le-homologous elingacushiwe.