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COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses. ​

文献信息 ​

DOI10.1038/s41586-020-2814-7
PMID32998157
期刊Nature
影响因子48.5
JCR 分区Q1
发表年份2020
被引次数1107
关键词COVID-19疫苗, 抗体反应, T细胞反应, BNT162b1, SARS-CoV-2
文献类型Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article
ISSN0028-0836
页码594-599
期号586(7830)
作者Ugur Sahin, Alexander Muik, Evelyna Derhovanessian, Isabel Vogler, Lena M Kranz, Mathias Vormehr, Alina Baum, Kristen Pascal, Jasmin Quandt, Daniel Maurus, Sebastian Brachtendorf, Verena Lörks, Julian Sikorski, Rolf Hilker, Dirk Becker, Ann-Kathrin Eller, Jan Grützner, Carsten Boesler, Corinna Rosenbaum, Marie-Cristine Kühnle, Ulrich Luxemburger, Alexandra Kemmer-Brück, David Langer, Martin Bexon, Stefanie Bolte, Katalin Karikó, Tania Palanche, Boris Fischer, Armin Schultz, Pei-Yong Shi, Camila Fontes-Garfias, John L Perez, Kena A Swanson, Jakob Loschko, Ingrid L Scully, Mark Cutler, Warren Kalina, Christos A Kyratsous, David Cooper, Philip R Dormitzer, Kathrin U Jansen, Özlem Türeci

一句话小结 ​

本研究评估了BNT162b1疫苗在健康成年人中的安全性和免疫反应，发现该疫苗能够引发强烈的抗体和T细胞反应，且其RBD结合的IgG浓度显著高于恢复个体的水平。研究结果表明，BNT162b1通过多种机制具备保护免受COVID-19的潜力，为应对疫情提供了有效的疫苗候选者。

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COVID-19疫苗 · 抗体反应 · T细胞反应 · BNT162b1 · SARS-CoV-2

摘要 ​

需要一种有效的疫苗来遏制严重急性呼吸综合症冠状病毒-2（SARS-CoV-2）疫情的传播。最近，我们报告了正在进行的安慰剂对照、观察者盲法的I/II期新冠病毒病2019（COVID-19）疫苗试验中BNT162b1的安全性、耐受性和抗体反应数据。BNT162b1是一种脂质纳米颗粒制成的修饰核苷酸mRNA，编码SARS-CoV-2刺突蛋白的受体结合域（RBD）。在此，我们呈现了对健康成年人（年龄18-55岁）进行的第二项非随机开放标签I/II期试验中接种BNT162b1后的抗体和T细胞反应数据。两剂1-50μg的BNT162b1引发了强烈的CD4+和CD8+ T细胞反应以及强大的抗体反应，其RBD结合的IgG浓度明显高于从COVID-19中恢复个体的血清中观察到的水平。在第43天，SARS-CoV-2血清中和抗体的几何平均滴度为恢复个体的0.7倍（1μg剂量）至3.5倍（50μg剂量）。免疫血清广泛中和了具有多种SARS-CoV-2刺突变体的假病毒。大多数参与者的T辅助细胞1型（TH1）倾斜的T细胞免疫反应中，RBD特异性的CD8+和CD4+ T细胞扩增显著。大量RBD特异性的CD8+和CD4+ T细胞产生了干扰素-γ。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，它通过多种有益机制具有保护免受COVID-19的潜力。

英文摘要 ​

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 protein1. 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 (TH1)-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.

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主要研究问题 ​

  1. BNT162b1疫苗在不同年龄段人群中的免疫反应是否存在差异？
  2. 除了TH1细胞反应，BNT162b1疫苗是否会引发其他类型的T细胞反应？
  3. 该疫苗在应对新出现的SARS-CoV-2变种方面的有效性如何？
  4. BNT162b1疫苗与其他COVID-19疫苗相比，免疫应答的持续时间是怎样的？
  5. 该疫苗的安全性数据是否在长期观察中保持一致，特别是在不同人群中？

核心洞察 ​

1. 研究背景和目的 ​

COVID-19疫情由严重急性呼吸综合症冠状病毒2型（SARS-CoV-2）引发，全球急需有效疫苗以遏制疫情的传播。BNT162b1是一种基于脂质纳米颗粒的修饰核苷酸mRNA疫苗，编码SARS-CoV-2刺突蛋白的受体结合域（RBD）。本研究旨在评估BNT162b1疫苗在健康成人中引发的抗体及T细胞免疫反应，以支持其安全性、耐受性及免疫效力。

2. 主要方法和发现 ​

本研究为一项非随机开放标签的I/II期临床试验，参与者为18至55岁的健康成年人。研究者对接种BNT162b1疫苗的受试者进行两剂量（1-50μg）的疫苗注射，并评估其抗体和T细胞反应。结果显示，接种后，参与者体内的RBD结合IgG浓度显著高于康复者的血清，且在第43天的SARS-CoV-2中和抗体几何平均滴度为康复者的0.7倍（1μg剂量）至3.5倍（50μg剂量）。免疫血清能够广泛中和多种SARS-CoV-2刺突变种。此外，大多数参与者的T细胞免疫反应呈TH1偏向，RBD特异性的CD8+和CD4+ T细胞均出现扩增，且大量的RBD特异性T细胞能够产生干扰素-γ。

3. 核心结论 ​

BNT162b1疫苗能够有效诱导强烈的抗体和T细胞反应，尤其是RBD特异性的CD4+和CD8+ T细胞反应，提示该疫苗通过多种有利机制可能对COVID-19提供保护。研究结果表明，BNT162b1具备了作为一种有效疫苗的潜力，能够显著增强机体的免疫反应。

4. 研究意义和影响 ​

本研究为BNT162b1疫苗的免疫效果提供了重要的数据支持，展示了该疫苗在诱导强效免疫反应方面的潜力。结果不仅为未来的疫苗开发提供了科学依据，也为公共卫生政策的制定提供了参考，确保在抗击COVID-19疫情过程中，能够快速有效地推广使用此类疫苗，以降低病毒传播、减少重症病例和住院需求，最终控制疫情的蔓延。

参考文献 ​

  1. Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies. - Alina Baum;Benjamin O Fulton;Elzbieta Wloga;Richard Copin;Kristen E Pascal;Vincenzo Russo;Stephanie Giordano;Kathryn Lanza;Nicole Negron;Min Ni;Yi Wei;Gurinder S Atwal;Andrew J Murphy;Neil Stahl;George D Yancopoulos;Christos A Kyratsous - Science (New York, N.Y.) (2020)

引用本文的文献 ​

  1. SARS-CoV-2 nucleocapsid protein forms condensates with viral genomic RNA. - Amanda Jack;Luke S Ferro;Michael J Trnka;Eddie Wehri;Amrut Nadgir;Xammy Nguyenla;Katelyn Costa;Sarah Stanley;Julia Schaletzky;Ahmet Yildiz - bioRxiv : the preprint server for biology (2021)
  2. A cell-based large-scale screening of natural compounds for inhibitors of SARS-CoV-2. - Zhe-Rui Zhang;Ya-Nan Zhang;Xiao-Dan Li;Hong-Qing Zhang;Shu-Qi Xiao;Fei Deng;Zhi-Ming Yuan;Han-Qing Ye;Bo Zhang - Signal transduction and targeted therapy (2020)
  3. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. - Edward E Walsh;Robert W Frenck;Ann R Falsey;Nicholas Kitchin;Judith Absalon;Alejandra Gurtman;Stephen Lockhart;Kathleen Neuzil;Mark J Mulligan;Ruth Bailey;Kena A Swanson;Ping Li;Kenneth Koury;Warren Kalina;David Cooper;Camila Fontes-Garfias;Pei-Yong Shi;Özlem Türeci;Kristin R Tompkins;Kirsten E Lyke;Vanessa Raabe;Philip R Dormitzer;Kathrin U Jansen;Uğur Şahin;William C Gruber - The New England journal of medicine (2020)
  4. Prevention and treatment of COVID-19: Focus on interferons, chloroquine/hydroxychloroquine, azithromycin, and vaccine. - Bianza Moise Bakadia;Feng He;Tiatou Souho;Lallepak Lamboni;Muhammad Wajid Ullah;Biaou Ode Boni;Abeer Ahmed Qaed Ahmed;Biampata Mutu Mukole;Guang Yang - Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie (2021)
  5. RBD-Fc-based COVID-19 vaccine candidate induces highly potent SARS-CoV-2 neutralizing antibody response. - Zezhong Liu;Wei Xu;Shuai Xia;Chenjian Gu;Xinling Wang;Qian Wang;Jie Zhou;Yanling Wu;Xia Cai;Di Qu;Tianlei Ying;Youhua Xie;Lu Lu;Zhenghong Yuan;Shibo Jiang - Signal transduction and targeted therapy (2020)
  6. The immunology of SARS-CoV-2 infections and vaccines. - Lilit Grigoryan;Bali Pulendran - Seminars in immunology (2020)
  7. SARS-CoV-2: Targeted managements and vaccine development. - Moiz Bakhiet;Sebastien Taurin - Cytokine & growth factor reviews (2021)
  8. SARS-CoV-2 mRNA Vaccines Foster Potent Antigen-Specific Germinal Center Responses Associated with Neutralizing Antibody Generation. - Katlyn Lederer;Diana Castaño;Daniela Gómez Atria;Thomas H Oguin;Sidney Wang;Tomaz B Manzoni;Hiromi Muramatsu;Michael J Hogan;Fatima Amanat;Patrick Cherubin;Kendall A Lundgreen;Ying K Tam;Steven H Y Fan;Laurence C Eisenlohr;Ivan Maillard;Drew Weissman;Paul Bates;Florian Krammer;Gregory D Sempowski;Norbert Pardi;Michela Locci - Immunity (2020)
  9. Nucleic Acid-Based Technologies Targeting Coronaviruses. - Thi Khanh Le;Clément Paris;Khadija Shahed Khan;Fran Robson;Wai-Lung Ng;Palma Rocchi - Trends in biochemical sciences (2021)
  10. Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials. - Luca Tudor Giurgea;Matthew James Memoli - Vaccines (2020)

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