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
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
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DOI：
10.1038/s41591-021-01330-9
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发表时间：
2021-04-22
期刊：
影响因子：
82.9
通讯作者：
Zhu, Fengcai
中科院分区：
文献类型：
--
作者：
Li, Jingxin;Hui, Aimin;Zhu, Fengcai
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候选疫苗BNT162b1的单中心、平行分组、双盲第一阶段试验的安全性、耐受性和免疫原性数据，该试验在144名健康的SARS-CoV-2-幼稚的中国参与者中进行。这些参与者以1：1：1的随机比例接受基础和加强疫苗接种，接种剂量分别为10mgBNT162b1或30mgBNT162b1或安慰剂，间隔21天，年轻人(18-55岁)和老年人(65-85岁)平均分配到每个治疗组(ChiCTR2000034825)。BNT162b1编码SARS-CoV-2刺激性糖蛋白受体结合域(RBD)，是临床研究中的几种基于信使RNA的候选疫苗之一。局部反应和全身反应一般呈剂量依赖性、一过性和轻中度。发热是唯一的3级不良反应。BNT162b1在年轻和老年中国成年人中都能诱导强大的干扰素-伽马T细胞对包括RBD的肽库的反应，几何平均中和效价在SARS-CoV-2聚合酶链式反应阳性至少14d后达到新冠肺炎恢复期人类血清的2.1倍(年轻人)和1.3倍(老年人)。总之，BNT162b1具有可接受的安全性，并在亚洲人群中产生高水平的体液和T细胞反应。信使RNA疫苗候选BNT162b1编码SARS-CoV-2刺突蛋白的受体结合区域，第一阶段试验结果显示，在中国年轻人和老年人中，抗体和T细胞反应都是安全和诱导的。
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 mu g or 30 mu 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-gamma 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.Phase 1 trial results of the messenger RNA vaccine candidate BNT162b1, which encodes the receptor-binding domain of the SARS-CoV-2 spike protein, show safety and elicitation of antibody and T cell responses in both younger and older Chinese adults.