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Tshuaj Tiv Thaiv Kab Mob Khaus Viv-19 (COVID-XNUMX) tshiab

sau los ntawm editor

Jiangsu Recbio Technology Co., Ltd. ("Recbio"), lub tuam txhab biopharmaceutical tsom rau kev tshawb fawb, kev tsim kho thiab kev lag luam ntawm cov tshuaj tiv thaiv tshiab uas tuaj yeem daws cov kab mob loj heev nrog lub nra hnyav, hnub no tshaj tawm cov txiaj ntsig zoo ntawm thawj-hauv-tib neeg (FIH ) sim ntawm ReCOV, ib tiam tshiab, recombinant ob yam tshuaj tiv thaiv COVID-19 subunit. Zuag qhia tag nrho, cov ntaub ntawv ua ntej pom tau hais tias ReCOV tau txais kev pom zoo thiab pom tias muaj kev nyab xeeb zoo. 20μg ReCOV induced high titer of anti-SARS-CoV-2 neutralizing antibodies, nrog tsawg kawg yog qib sib piv dua li cov ntaub ntawv luam tawm nrog cov tshuaj tiv thaiv mRNA, kwv yees qhov muaj peev xwm ntawm ReCOV hauv kev tiv thaiv SARS-COV-2 induced kab mob.

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“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.”

Qhov kev sim FIH txuas ntxiv no yog ib qho kev tshawb fawb randomized, ob qhov muag tsis pom kev, cov placebo-tswj kev tshawb fawb los soj ntsuam kev nyab xeeb, reactogenicity, thiab immunogenicity ntawm 2 ascending koob tshuaj ReCOV, thaum muab raws li 2 intramuscular txhaj (nrog 21 hnub sib nrug) hauv cov kev noj qab haus huv. Hnub no Recbio tau tshaj tawm ib feem ntawm cov ntaub ntawv tsis pom kev ntawm kev nyab xeeb, reactogenicity thiab immunogenicity rau Cohort 1 (cov neeg laus dua / ReCOV 20μg).

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.

Qhov tseem ceeb, raws li kev sib koom ua ke ntawm tib neeg cov ntshav los ntawm cov neeg mob convalescent, WHO tus qauv thoob ntiaj teb (xws li 20/136, muab los ntawm National Institute for Biological Standards and Control [NIBSC]) tau siv dav los ntsuas cov txheej txheem kuaj mob sib txawv.

Lub caij no, cov ntaub ntawv tiv thaiv kab mob ntawm tes tau pom tias ReCOV tuaj yeem ua rau cov tshuaj tiv thaiv kab mob tshwj xeeb CD4 + T cell cov lus teb hauv cov neeg laus, xav txog hauv IFN-γ thiab IL-2 ntau lawm, ib qho kev pom tseeb rau Th1 phenotype tau pom nrog qib siab ntawm Th1 cytokines kuaj pom ntawm Hnub 36 (14 hnub tom qab txhaj tshuaj thib 2).

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.

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editor

Editor in Chief yog Linda Hohnholz.

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1 Saib

  • Linda maam,
    You won’t imagine how much your article is giving hopes to people like me and my country, situated at the other end of the world. We completely lost hope about whether we shall come out of the tunnel with regards to this Covid epidemic. Linda maam,you are no less than the messenger of God. God keeps you, your family and your country safe too.