The coronavirus disease 2019(COVID-19)pandemic remains a significant global health challenge.Older adults are the population at high risk of developing severe COVID-19 or death[1–3].To date,dozens of vaccines for pro...The coronavirus disease 2019(COVID-19)pandemic remains a significant global health challenge.Older adults are the population at high risk of developing severe COVID-19 or death[1–3].To date,dozens of vaccines for prototype severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)have received emergency use authorization or conditional marketing approval in many countries[4].ZF2001,a protein subunit vaccine comprising two copies of tandem receptor-binding domain(RBD)from prototype SARS-CoV-2(HB-02 strain)[5,6],has demonstrated safety and immunogenicity in populations aged 3–17 and 18–59 after three doses of vaccination[7,8].Moreover,it has shown good efficacy in the prevention of symptomatic COVID-19 caused by infections from the alpha,kappa,and delta variants after a six-month follow-up for adults beyond 18 years of age in a phase 3 trial[9].ZF2001 was safe and well-tolerated in a large cohort of adults(R18 years of age),and the incidence of adverse events was lower among the participants 60 years of age or older than among those aged 18–59[9].However,its durability and immunogenicity in individuals 60 years of age and older have not been reported and need further investigation.Here,we reported the phase 1 trial of ZF2001 in adults aged 60 or older in China to determine the safety,tolerability,and immunogenicity of ZF2001 in older populations after short(1 month)-and long(6 months)-term follow-up.Moreover,we conducted a post-hoc analysis of serum samples to assess their neutralization capacity against omicron variants.展开更多
基金This work is funded by Anhui Zhifei Longcom Biopharmaceutical,National Key R&D Program of China(2021YFA1300803)the National Natural Science Foundation of China(82122031)We thank the staff of the Biosafety Level 3 Laboratory(Institute of Microbiology,Chinese Academy of Sciences)for their help in live virus experiments,Yawen Liu for her help in pseudovirus experiments,and Grammarly for text improvement.
文摘The coronavirus disease 2019(COVID-19)pandemic remains a significant global health challenge.Older adults are the population at high risk of developing severe COVID-19 or death[1–3].To date,dozens of vaccines for prototype severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)have received emergency use authorization or conditional marketing approval in many countries[4].ZF2001,a protein subunit vaccine comprising two copies of tandem receptor-binding domain(RBD)from prototype SARS-CoV-2(HB-02 strain)[5,6],has demonstrated safety and immunogenicity in populations aged 3–17 and 18–59 after three doses of vaccination[7,8].Moreover,it has shown good efficacy in the prevention of symptomatic COVID-19 caused by infections from the alpha,kappa,and delta variants after a six-month follow-up for adults beyond 18 years of age in a phase 3 trial[9].ZF2001 was safe and well-tolerated in a large cohort of adults(R18 years of age),and the incidence of adverse events was lower among the participants 60 years of age or older than among those aged 18–59[9].However,its durability and immunogenicity in individuals 60 years of age and older have not been reported and need further investigation.Here,we reported the phase 1 trial of ZF2001 in adults aged 60 or older in China to determine the safety,tolerability,and immunogenicity of ZF2001 in older populations after short(1 month)-and long(6 months)-term follow-up.Moreover,we conducted a post-hoc analysis of serum samples to assess their neutralization capacity against omicron variants.
