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

Literature Information ​

DOI10.1038/s41586-020-2814-7
PMID32998157
JournalNature
Impact Factor48.5
JCR QuartileQ1
Publication Year2020
Times Cited1107
KeywordsCOVID-19 vaccine, antibody response, T cell response, BNT162b1, SARS-CoV-2
Literature TypeClinical Trial, Phase I, Clinical Trial, Phase II, Journal Article
ISSN0028-0836
Pages594-599
Issue586(7830)
AuthorsUgur 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

TL;DR ​

The BNT162b1 mRNA vaccine, targeting the receptor binding domain of the SARS-CoV-2 spike protein, demonstrated robust antibody and T cell responses in a phase I/II trial with healthy adults, yielding significantly higher RBD-binding IgG concentrations compared to recovered COVID-19 patients. These findings underscore the vaccine's potential to elicit a multifaceted immune response, suggesting it may effectively protect against COVID-19.

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COVID-19 vaccine · antibody response · T cell response · BNT162b1 · SARS-CoV-2

Abstract ​

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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Primary Questions Addressed ​

  1. What are the long-term effects of the BNT162b1 vaccine on T cell immunity?
  2. How does the immune response elicited by BNT162b1 compare to other COVID-19 vaccines in terms of antibody and T cell responses?
  3. What specific mechanisms contribute to the TH1-skewed T cell responses observed after BNT162b1 vaccination?
  4. How do variations in dosage (1-50 μg) of BNT162b1 influence the magnitude and quality of the immune response?
  5. What implications do the robust neutralizing antibody responses have for the vaccine's effectiveness against emerging SARS-CoV-2 variants?

Key Findings ​

1. Research Background and Objective: The COVID-19 pandemic, caused by SARS-CoV-2, necessitates the urgent development of an effective vaccine to mitigate its spread. The BNT162b1 vaccine, which utilizes lipid nanoparticle-formulated nucleoside-modified mRNA encoding the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, aims to elicit a robust immune response in healthy adults. This study evaluates the safety, tolerability, and immunogenicity of BNT162b1 in a phase I/II trial to assess its potential in providing immunity against COVID-19.

2. Main Methods and Findings: In this non-randomized, open-label phase I/II trial, healthy adults aged 18-55 received two doses of BNT162b1 at varying concentrations (1-50 μg). The study measured the immune responses, focusing on antibody production and T cell activation. Results indicated that BNT162b1 successfully elicited strong antibody responses, with RBD-binding IgG levels significantly higher than those found in individuals who had recovered from COVID-19. Specifically, serum-neutralizing antibody geometric mean titres on day 43 ranged from 0.7-fold (1-μg dose) to 3.5-fold (50-μg dose) compared to the recovered cohort. Furthermore, the immune sera demonstrated the ability to neutralize a variety of pseudoviruses representing different SARS-CoV-2 spike variants. A majority of participants exhibited TH1-skewed T cell immune responses, characterized by the expansion of RBD-specific CD4+ and CD8+ T cells, and a substantial proportion of these cells produced interferon-γ.

3. Core Conclusion: The BNT162b1 mRNA vaccine induces robust and multifaceted immune responses, characterized by high levels of RBD-specific antibodies and T cells. The observed TH1-skewed responses and significant cytokine production suggest that the vaccine is capable of providing a protective effect against COVID-19 through various immunological mechanisms.

4. Research Significance and Impact: This study underscores the potential of the BNT162b1 vaccine to confer strong immunity against COVID-19, highlighting its role in the broader strategy to combat the pandemic. The ability to elicit both antibody and T cell responses may enhance the effectiveness of vaccination in diverse populations, potentially leading to durable immunity and reduced transmission of SARS-CoV-2. The findings contribute valuable insights into mRNA vaccine technology and its application in future vaccine development against emerging infectious diseases.

References ​

  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)

Literatures Citing This Work ​

  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)

... (1097 more literatures)

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