Ọmụmụ ihe mbụ n'ime mmadụ nke onye nyocha ọgwụ mgbochi COVID-19 ọhụrụ

• 20μg ReCOV butere ọkwa dị elu nke mgbochi SARS-CoV-2 na-egbochi ọgwụ mgbochi, yana opekata mpe nhatanha karịa data ebipụtara na ọgwụ mgbochi mRNA, na-ebu amụma ịdị irè nke ReCOV na igbochi ọrịa SARS-COV-2 kpatara.
• A ga-enyochakwa ReCOV maka ịdị mma na nchekwa na nnukwu ule ụlọ ọgwụ n'oge adịghị anya

Jiangsu Recbio Technology Co., Ltd. ) nnwale nke ReCOV, ọgbọ ọhụrụ, ọgwụ mgbochi COVID-19 mejupụtara akụkụ abụọ. N'ozuzu, data mbido gosipụtara na ReCOV kwadoro nke ọma ma gosipụta profaịlụ nchekwa dị mma. 20μg ReCOV butere ọkwa dị elu nke mgbochi SARS-CoV-2 na-egbochi ọgwụ mgbochi, yana opekata mpe nha anya karịa data ebipụtara na ọgwụ mgbochi mRNA, na-ebu amụma ikike ReCOV na-egbochi ọrịa SARS-COV-2 butere.

"A na-agba anyị ume site na nchekwa mbụ na profaịlụ immunogenicity nke ReCOV na ule FIH a," Dr. Liu Yong, Onye isi oche na onye isi njikwa kwuru. "Ọgwụ mgbochi mgbochi ka bụ ụzọ kachasị dị irè iji gbochie ọrịa SARS-CoV-2 na ịchịkwa ọrịa na-efe efe zuru ụwa ọnụ. Anyị na-atụ anya ịnye ọgbọ ọzọ nke ọgwụ mgbochi COVID-19 nwere ike dị na nchekwa, ịdị irè na ịnweta ya, ma ga-ebuli ReCOV n'ime ọmụmụ ụlọ ọgwụ buru ibu n'oge na-adịghị anya iji nyochaa ịdị mma na nchekwa ya. "

Ọnwụnwa FIH a na-aga n'ihu bụ usoro nyocha, nke kpuru okpukpu abụọ, nke a na-achịkwa ebebo iji nyochaa nchekwa, reactogenicity, na immunogenicity nke 2 na-arị elu doses nke ReCOV, mgbe a na-enye ya dị ka 2 intramuscular injections (ya na ụbọchị 21 dị iche) na isiokwu ahụike. Taa Recbio kọrọ data nchekwa ekpuchighị ekpuchi, mmeghachi omume na immunogenicity maka ndị otu 1 (ndị okenye na-eto eto/ReCOV 20μg).

Ndị otu a debanyere ndị sonyere 25 bụ ndị dị afọ 18 ruo 55. N'ime nnwale ahụ, agbanwere SARS-Cov-2-neutralizing antibody geometric mean titers (GMTs) ka ọ bụrụ ngalaba WHO/NIBSC nke IU/mL maka ntụnyere nke iwepu ihe mgbochi mgbochi na nke ọgwụ mgbochi ndị ọzọ a na-ejikarị. Recbio nwetara GMT nke 1643.2 IU/mL maka igbochi ọgwụ mgbochi na ụbọchị iri na anọ ka usoro ọgwụgwọ abụọ nke ReCOV gasịrị, yana ọnụọgụ seropositive (SPR) na seroconversion (SCR) dị ka 14%, na-atụ aro ịdị mma nke ReCOV na igbochi SARS-COV-100. butere ọrịa. Emere ọgwụ mgbochi SARS-CoV-2 site na ụlọ nyocha etiti nke ọmụmụ (2Biolabs). Dị ka ọmụmụ tupu ebipụta na nso nso a¹, GMT nke SARSCoV-2 mgbochi mgbochi mgbochi bụ 1404.16 IU/mL na 928.75 IU/ml ụbọchị 14 ka usoro ọgwụgwọ abụọ gachara maka ọgwụ mgbochi Moderna na BioNTech/Pfizer mRNA, n'otu n'otu.

N'ụzọ doro anya, dabere na plasma mmadụ jikọtara ọnụ sitere na ndị ọrịa na-ahụ anya, ọkọlọtọ mba ụwa nke WHO (gụnyere 20/136, nke National Institute for Biological Standards and Control [NIBSC] nyere) ka a na-ejikarị mee ihe iji dozie usoro nyocha dị iche iche.

Ka ọ dị ugbu a, data immunogenicity cellular gosipụtara na ReCOV nwere ike iweta nzaghachi antigen-kpọmkwem CD4 + T cell na ndị toro eto, na-egosipụta na mmepụta IFN-γ na IL-2, omume doro anya na Th1 phenotype hụrụ na ọkwa kachasị elu nke cytokines Th1 achọpụtara na Ụbọchị 36 (ụbọchị iri na anọ mgbe ịgba ọgwụ mgbochi nke abụọ gasịrị).

A na-anabatakarị ReCOV nke ọma site na ezigbo nchekwa yana profaịlụ nnabata. Ọtụtụ n'ime ihe ọjọọ dị obere n'ịdị njọ. Enweghị SAE ma ọ bụ TEAE nke na-eduga n'ịkwụsị n'oge, enweghị akara dị oke mkpa dị mkpa / nsonaazụ ụlọ nyocha nwere mkpa ụlọ ọgwụ.

Recbio mepụtara nyiwe teknụzụ na-egbutu ọnụ atọ maka mmepe adjuvant ọhụrụ, injinịa protein na nyocha ọgwụ mgbochi. N'ịkwado site na nyiwe ndị a, Recbio na-aga n'ihu na-achọpụta na ịzụlite otu zuru oke nke ndị na-achọ ọgwụ mgbochi ọhụrụ, dị ka ọgbọ na-esote HPV, shingles na flu.