Hāʻawi ka lāʻau lapaʻau COVID-19 i loko o CanSinoBIO i nā pono kūʻokoʻa a hōʻike i kahi hopena hou i ka pane ʻana i ka maʻi maʻi COVID-19. ʻO ka lāʻau lapaʻau manuahi ʻole, ʻaʻole invasive ka manaʻo e hāʻawi i ka pale wikiwiki, maʻamau a nui me ka hoʻokele maʻalahi. Hoʻomaʻamaʻa ka lāʻau lapaʻau inhaled i ka hana hoʻomanaʻo immune o ke kino ma o ka hoʻohālikelike ʻana i ka maʻi kūlohelohe o ka maʻi, ʻaʻole ia e hoʻoulu wale i ka humoral a me ka cellular immunity, akā hoʻoulu maikaʻi hoʻi i ka immunity mucosal e hoʻokō i ka ʻekolu, ka pale ākea.
Ua hōʻike ʻia ka haʻawina ʻo ka hoʻonui ʻana i ka lāʻau lapaʻau inactivated me ka Inhalation Convidecia ™ e hoʻoulu i ka pane ʻana o ka immune mucosal ikaika. Ua ʻike ʻia ke kiʻekiʻe o ka RBD-specific IgA-binding antibody i ka serum o nā kumuhana 14 mau lā ma hope o ka hoʻopaʻa ʻana.
ʻO ka nānā ʻana o ke aʻo ʻana i ke kino
Ua hoʻopaʻa ʻia ke aʻo ʻana, ʻaʻole makapō a hoʻopaʻa like ʻia, me 420 mau mea komo i hāʻawi ʻia i ʻekolu mau hui 140-kanaka. Ua loaʻa i hoʻokahi pūʻulu i hoʻokahi pānaʻi haʻahaʻa (0.1 ml) o ka Inhalation Convidecia™ hoʻokahi pūʻulu i loaʻa i hoʻokahi kumu kiʻekiʻe (0.2 ml) o ka lāʻau lapaʻau inhaled; a ʻo ka hui hope loa i loaʻa i ka lāʻau lapaʻau i hoʻohana ʻole ʻia e ka injection intramuscular. Ua hōʻike ka haʻawina i ka palekana a me ka immunogenicity o ka Inhalation Convidecia ™ ma ke ʻano he mea hoʻoikaika e hoʻohana wale ana i hoʻokahi hapalima a ʻelua hapalima paha o kāna ʻano intramuscular.
Hōʻoiaʻiʻo i ka palekana a me ka pono o ka CanSinoBIO's Inhaled Vaccine
Ua hōʻike ʻia nā ʻikepili i nā hopena palekana he liʻiliʻi nā hihia o nā hanana ʻino ma hope o ka hoʻoikaika heterologous o ka Inhalation Convidecia ™ ma mua o ka poʻe i lawelawe ʻia me ka homologous booster o ka lāʻau lapaʻau inactivated. ʻAʻole i ʻike ʻia nā hanana ʻino koʻikoʻi i loko o nā pūʻulu inhalation ʻelua 28 mau lā ma hope o ka hoʻokō ʻia ʻana o ka booster, ʻaʻole hoʻi i loaʻa nā hōʻike e pili ana i nā mea ʻino ʻole o ka hana o ka māmā.
Ua hōʻike ʻia ka ʻikepili i ka immunogenicity i ka inhaled heterologous booster elicited kahi kiʻekiʻe kiʻekiʻe o ka neutralizing antibodies ma mua o ka poʻe me ka homogeneous booster o ka lāʻau lapaʻau inactivated. ʻAʻohe ʻokoʻa koʻikoʻi o ka pane ʻana i ka pale ma waena o nā hui inhalation ʻelua, ʻo ia ka 6.7 a 10.7 mau manawa kiʻekiʻe ma mua o ka mea i ʻike ʻia ma ke kolu o ka hui me kahi homologous booster ma waena o nā lā 14 a me 28 ma hope o ka pana booster. Eia kekahi, ua piʻi ka pae o ka neutralizing antibodies i ka lā 28 ma hope o ka inhaled booster ma 6054.1 (95% CI 4584.1, 7995.0) no ka hui haʻahaʻa a me 4221.3 (2976.9, 5985.3) IU / ml no ka hui kiʻekiʻe. Ua hōʻike pū ʻia ua hāʻawi ʻo Inhalation Convidecia™ i kahi kiʻekiʻe o ka pale-cross kiʻekiʻe e kūʻē i ka ʻano Delta, me nā kiʻekiʻe kiʻekiʻe o ka neutralizing antibodies i kiʻi ʻia ma mua o nā lāʻau lapaʻau inactivated.
Ke hoʻohālikelike ʻia me ka booster inactivated, ua hoʻonui nui ʻia ʻo 2019-nCoV spike protein-specific IFN-γ a me IL-2 ELISA hiki ke ʻike ʻia i nā lā 7 ma hope o ka hoʻoulu inhalation. ʻO nā pae haʻiʻōlelo o INF-γ a me IL-2 i loko o ka hui hoʻoulu inhalation he 6 a 10 mau manawa a me 4 a 5 mau manawa kiʻekiʻe ma mua o ka poʻe i loko o ka hui hoʻoulu lāʻau lapaʻau inactivated. Hōʻike ia i ka hoʻohālikelike ʻia me ka homologous booster homologous inactivated, hiki i ka inhaled heterologous booster ke hoʻoulu nui i ka pane immune cellular type Th1, aʻo nā mea e like me ke kāne a me ka makahiki ʻaʻohe hopena i ka pane immune cellular.
Eia kekahi, ʻoi aku ka kiʻekiʻe o ka RBD-specific ELISA antibody level i hoʻokomo ʻia e ka inhaled heterologous booster ma mua o ka homologous booster homologous inactivated 28 mau lā ma hope o ka lawelawe ʻana, ʻo ka pae antibody RBD i ka hui inhalation haʻahaʻa he 13 mau manawa ma mua o kēlā ka hui homologous vaccine inactivated.
He aha e lawe ʻia mai kēia ʻatikala:
- Eia kekahi, ʻoi aku ka kiʻekiʻe o ka RBD-specific ELISA antibody level i hoʻokomo ʻia e ka inhaled heterologous booster ma mua o ka homologous booster homologous inactivated 28 mau lā ma hope o ka lawelawe ʻana, ʻo ka pae antibody RBD i ka hui inhalation haʻahaʻa he 13 mau manawa ma mua o kēlā ka hui homologous vaccine inactivated.
- The expression levels of INF-γ and IL-2 in the inhalation booster group were 6 to 10 times and 4 to 5 times higher than those in the inactivated vaccine booster group, respectively.
- The data on safety results showed that there were fewer cases of adverse events after the heterologous booster of the Inhalation Convidecia™than those administered with a homologous booster of inactivated vaccine.