Éischt-am-Mënsch Studie vun engem neie COVID-19 Impfungskandidat

• 20μg ReCOV induced high titer of anti-SARS-CoV-2 neutralizing antibodies, with at least comparable level than published data with mRNA vaccines, predicting a promising efficacy of ReCOV in preventing SARS-COV-2 induced diseases
• ReCOV will be further evaluated for efficacy and safety in larger clinical trials soon

Jiangsu Recbio Technology Co., Ltd. ("Recbio"), eng biopharmazeutesch Firma, déi sech op d'Fuerschung, d'Entwécklung an d'Kommerzialiséierung vun innovativen Impfungen konzentréiert, déi prevalent Krankheeten mat bedeitende Belaaschtung adresséiere kënnen, huet haut positiv virleefeg Resultater vun Éischt-am-Mënsch (FIH) ugekënnegt. ) Prozess vu ReCOV, eng nei Generatioun, rekombinant Zwee-Komponent COVID-19 Ënnerunitéit Impfung. Insgesamt hunn déi virleefeg Donnéeën bewisen datt ReCOV gutt toleréiert goufen an e gudde Sécherheetsprofil gewisen hunn. 20μg ReCOV induzéiert héijen Titer vun Anti-SARS-CoV-2 neutraliséierend Antikörper, mat op d'mannst vergläichbaren Niveau wéi publizéiert Donnéeën mat mRNA Impfungen, virauszesoen e verspriechend Potenzial vu ReCOV fir SARS-COV-2 induzéiert Krankheeten ze vermeiden.

“We are encouraged by the preliminary safety and immunogenicity profile of ReCOV in this FIH trial,” said Dr. Liu Yong, Chairman and General Manager. “Prophylactic vaccines are still the most effective means to prevent SARS-CoV-2 infection and control the global pandemic. We are looking forward to providing a next-generation of COVID-19 vaccine with the potential in safety, efficacy and accessibility, and will advance ReCOV into larger clinical studies soon to evaluate its efficacy and safety.”

Dëse lafende FIH-Prozess ass eng randomiséierter, doppelblannend, placebo-kontrolléiert Studie fir d'Sécherheet, d'Reaktogenizitéit an d'Immunogenizitéit vun 2 opsteigend Dosen ReCOV ze evaluéieren, wann se als 2 intramuskulär Injektiounen (mat 21 Deeg ausser) a gesonde Sujeten verwalt ginn. Haut huet Recbio deelweis ongeblindt Daten iwwer Sécherheet, Reaktogenizitéit an Immunogenizitéit fir Cohort 1 (méi jonk Erwuessener / ReCOV 20μg) gemellt.

This cohort enrolled 25 participants who were 18 to 55 years of age. In the trial, the SARS-Cov-2-neutralizing antibody geometric mean titers (GMTs) were converted to WHO/NIBSC unit of IU/mL for comparisons of neutralizing antibody titers with those of other widely used vaccines. Recbio obtained GMTs of 1643.2 IU/mL for neutralizing antibodies at 14 days after two doses of ReCOV, with both seropositive rate (SPR) and seroconversion rate (SCR) as 100%, suggesting a promising efficacy of ReCOV in preventing SARS-COV-2 induced diseases. SARS-CoV-2 neutralizing antibodies were performed by central laboratory of the study (360Biolabs). According to a recent pre-print study¹, the GMT of SARSCoV-2 neutralizing antibodies were 1404.16 IU/mL and 928.75 IU/mL 14 days after two doses for Moderna and BioNTech/Pfizer mRNA vaccines, respectively.

Notamment, baséiert op poolte mënschleche Plasma aus erhuelsamen Patienten, WHO internationale Standard (dorënner 20/136, zur Verfügung gestallt vum National Institute for Biological Standards and Control [NIBSC]) gouf wäit benotzt fir verschidde diagnostesch Techniken ze kalibréieren.

Mëttlerweil hunn d'zellulär Immunogenizitéitsdaten gewisen datt ReCOV antigenspezifesch CD4+ T Zell Äntwerte bei méi jonken Erwuessener induzéieren konnt, reflektéiert an der IFN-γ an IL-2 Produktioun, en offensichtlechen Trend zu Th1 Phänotyp gouf observéiert mat engem Héichpunkt vun Th1 Zytokine festgestallt Dag 36 (14 Deeg no der 2. Impfung).

ReCOV was generally well tolerated with a good safety and tolerability profile. The majority of adverse events were mild in severity. No SAE or TEAE leading to early discontinuation, no abnormal vital signs/laboratory testing results with clinical significance.

Recbio developed three cutting-edge technology platforms for novel adjuvant development, protein engineering and immunological evaluation. Supported by these platforms, Recbio continue to discover and develop a full suite of innovative vaccine candidates, such as next-generation HPV, shingles and Flu vaccines.