An effective vaccine is needed to halt the spread of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. Recently, we reported safety, tolerability and antibody response data from an ongoing placebo-controlled, observer-blinded phase I/II coronavirus disease 2019 (COVID-19) vaccine trial with BNT162b1, a lipid nanoparticle-formulated nucleoside-modified mRNA that encodes the receptor binding domain (RBD) of the SARS-CoV-2 spike protein 1 . Here we present antibody and T cell responses after vaccination with BNT162b1 from a second, non-randomized open-label phase I/II trial in healthy adults, 18–55 years of age. Two doses of 1–50 μg of BNT162b1 elicited robust CD4 + and CD8 + T cell responses and strong antibody responses, with RBD-binding IgG concentrations clearly above those seen in serum from a cohort of individuals who had recovered from COVID-19. Geometric mean titres of SARS-CoV-2 serum-neutralizing antibodies on day 43 were 0.7-fold (1-μg dose) to 3.5 - fold (50-μg dose) those of the recovered individuals. Immune sera broadly neutralized pseudoviruses with diverse SARS-CoV-2 spike variants. Most participants had T helper type 1 (T H 1)-skewed T cell immune responses with RBD-specific CD8 + and CD4 + T cell expansion. Interferon-γ was produced by a large fraction of RBD-specific CD8 + and CD4 + T cells. The robust RBD-specific antibody, T cell and favourable cytokine responses induced by the BNT162b1 mRNA vaccine suggest that it has the potential to protect against COVID-19 through multiple beneficial mechanisms. In a phase I/II dose-escalation clinical trial, the mRNA COVID-19 vaccine BNT162b1 elicits specific T cell and antibody responses that suggest it has protective potential.

中文翻译：

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COVID-19 疫苗 BNT162b1 引发人类抗体和 TH1 T 细胞反应

需要一种有效的疫苗来阻止严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 大流行的传播。最近，我们报告了一项正在进行的安慰剂对照、观察者盲法 I/II 期冠状病毒病 2019 (COVID-19) 疫苗试验的安全性、耐受性和抗体反应数据，其中 BNT162b1 是一种脂质纳米颗粒配制的核苷修饰 mRNA，编码SARS-CoV-2 刺突蛋白 1 的受体结合域 (RBD)。在这里，我们展示了在 18-55 岁的健康成人中进行的第二次非随机开放标签 I/II 期试验的 BNT162b1 疫苗接种后的抗体和 T 细胞反应。两剂 1-50 μg BNT162b1 引起强烈的 CD4 + 和 CD8 + T 细胞反应和强烈的抗体反应，与 RBD 结合的 IgG 浓度明显高于从 COVID-19 中康复的一组个体的血清中所见的浓度。第 43 天 SARS-CoV-2 血清中和抗体的几何平均滴度是康复者的 0.7 倍（1 微克剂量）至 3.5 倍（50 微克剂量）。免疫血清广泛中和具有多种 SARS-CoV-2 刺突变体的假病毒。大多数参与者具有 T 辅助 1 型 (TH 1) 倾斜的 T 细胞免疫反应，具有 RBD 特异性 CD8 + 和 CD4 + T 细胞扩增。干扰素-γ 由大部分 RBD 特异性 CD8 + 和 CD4 + T 细胞产生。BNT162b1 mRNA 疫苗诱导的强大的 RBD 特异性抗体、T 细胞和有利的细胞因子反应表明它有可能通过多种有益机制预防 COVID-19。