NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Fosun Pharma, Boston, MA, USA.
Nat Med. 2021 Jun;27(6):1062-1070. doi: 10.1038/s41591-021-01330-9. Epub 2021 Apr 22.
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 µg or 30 µg 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-γ 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.
需要一种有效的疫苗来结束严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)大流行。在这里,我们评估了正在进行的一项在中国江苏省进行的单中心、平行组、双盲 1 期试验中疫苗候选物 BNT162b1 的初步安全性、耐受性和免疫原性数据,该试验纳入了 144 名 SARS-CoV-2 未感染的健康中国参与者。这些参与者按照 1:1:1 的比例随机分为 3 组,分别接受 10µg 或 30µg BNT162b1 或安慰剂的基础免疫和加强免疫,间隔 21 天,每组中年轻(18-55 岁)和老年(65-85 岁)参与者的分配比例相等(ChiCTR2000034825)。BNT162b1 编码 SARS-CoV-2 刺突糖蛋白受体结合域(RBD),是几种正在临床研究中的信使 RNA 疫苗候选物之一。局部反应和全身事件通常与剂量有关,是短暂的,且为轻度至中度。发热是唯一的 3 级不良事件。BNT162b1 在年轻和老年中国成年人中诱导了针对 RBD 肽池的强烈干扰素-γ T 细胞反应,几何平均中和滴度分别比 COVID-19 恢复期人类血清的 2.1 倍(年轻参与者)和 1.3 倍(老年参与者)高,这些血清是在 SARS-CoV-2 聚合酶链反应检测呈阳性至少 14 天后获得的。总之,BNT162b1 在亚洲人群中具有可接受的安全性,并产生高水平的体液和 T 细胞反应。
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