tetano
Editor, Senior Moderator
Nat Med
. 2021 Apr 22.
doi: 10.1038/s41591-021-01330-9. Online ahead of print.
Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study
Jingxin Li[SUP] #[/SUP][SUP] 1 [/SUP], Aimin Hui[SUP] #[/SUP][SUP] 2 [/SUP], Xiang Zhang[SUP] 3 [/SUP], Yumei Yang[SUP] 4 [/SUP], Rong Tang[SUP] 1 [/SUP], Huayue Ye[SUP] 5 6 [/SUP], Ruiru Ji[SUP] 7 [/SUP], Mei Lin[SUP] 8 [/SUP], Zhongkui Zhu[SUP] 3 [/SUP], ?zlem T?reci[SUP] 9 [/SUP], Eleni Lagkadinou[SUP] 9 [/SUP], Siyue Jia[SUP] 1 [/SUP], Hongxing Pan[SUP] 1 [/SUP], Fuzhong Peng[SUP] 5 8 [/SUP], Zhilong Ma[SUP] 3 [/SUP], Zhenggang Wu[SUP] 8 [/SUP], Xiling Guo[SUP] 1 [/SUP], Yunfeng Shi[SUP] 1 [/SUP], Alexander Muik[SUP] 9 [/SUP], U?ur ?ahin[SUP] 9 [/SUP], Li Zhu[SUP] 10 [/SUP], Fengcai Zhu[SUP] 11 12 [/SUP]
Affiliations
Abstract
An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Here, we assess the preliminary safety, tolerability and immunogenicity data from an ongoing single-center (in Jiangsu province, China), parallel-group, double-blind phase 1 trial of the vaccine candidate BNT162b1 in 144 healthy SARS-CoV-2-naive Chinese participants. These participants are randomized 1:1:1 to receive prime and boost vaccinations of 10 ?g or 30 ?g BNT162b1 or placebo, given 21 d apart, with equal allocation of younger (aged 18-55 years) and older adults (aged 65-85 years) to each treatment group (ChiCTR2000034825). BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) and is one of several messenger RNA-based vaccine candidates under clinical investigation. Local reactions and systemic events were generally dose dependent, transient and mild to moderate. Fever was the only grade 3 adverse event. BNT162b1 induced robust interferon-? T cell responses to a peptide pool including the RBD in both younger and older Chinese adults, and geometric mean neutralizing titers reached 2.1-fold (for younger participants) and 1.3-fold (for the older participants) that of a panel of COVID-19 convalescent human sera obtained at least 14 d after positive SARS-CoV-2 polymerase chain reaction test. In summary, BNT162b1 has an acceptable safety profile and produces high levels of humoral and T cell responses in an Asian population.
. 2021 Apr 22.
doi: 10.1038/s41591-021-01330-9. Online ahead of print.
Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study
Jingxin Li[SUP] #[/SUP][SUP] 1 [/SUP], Aimin Hui[SUP] #[/SUP][SUP] 2 [/SUP], Xiang Zhang[SUP] 3 [/SUP], Yumei Yang[SUP] 4 [/SUP], Rong Tang[SUP] 1 [/SUP], Huayue Ye[SUP] 5 6 [/SUP], Ruiru Ji[SUP] 7 [/SUP], Mei Lin[SUP] 8 [/SUP], Zhongkui Zhu[SUP] 3 [/SUP], ?zlem T?reci[SUP] 9 [/SUP], Eleni Lagkadinou[SUP] 9 [/SUP], Siyue Jia[SUP] 1 [/SUP], Hongxing Pan[SUP] 1 [/SUP], Fuzhong Peng[SUP] 5 8 [/SUP], Zhilong Ma[SUP] 3 [/SUP], Zhenggang Wu[SUP] 8 [/SUP], Xiling Guo[SUP] 1 [/SUP], Yunfeng Shi[SUP] 1 [/SUP], Alexander Muik[SUP] 9 [/SUP], U?ur ?ahin[SUP] 9 [/SUP], Li Zhu[SUP] 10 [/SUP], Fengcai Zhu[SUP] 11 12 [/SUP]
Affiliations
- PMID: 33888900
- DOI: 10.1038/s41591-021-01330-9
Abstract
An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Here, we assess the preliminary safety, tolerability and immunogenicity data from an ongoing single-center (in Jiangsu province, China), parallel-group, double-blind phase 1 trial of the vaccine candidate BNT162b1 in 144 healthy SARS-CoV-2-naive Chinese participants. These participants are randomized 1:1:1 to receive prime and boost vaccinations of 10 ?g or 30 ?g BNT162b1 or placebo, given 21 d apart, with equal allocation of younger (aged 18-55 years) and older adults (aged 65-85 years) to each treatment group (ChiCTR2000034825). BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) and is one of several messenger RNA-based vaccine candidates under clinical investigation. Local reactions and systemic events were generally dose dependent, transient and mild to moderate. Fever was the only grade 3 adverse event. BNT162b1 induced robust interferon-? T cell responses to a peptide pool including the RBD in both younger and older Chinese adults, and geometric mean neutralizing titers reached 2.1-fold (for younger participants) and 1.3-fold (for the older participants) that of a panel of COVID-19 convalescent human sera obtained at least 14 d after positive SARS-CoV-2 polymerase chain reaction test. In summary, BNT162b1 has an acceptable safety profile and produces high levels of humoral and T cell responses in an Asian population.