U. Şahin, A. Muik, E. Derhovanessian, I. Vogler, L. Kranz, M. Vormehr, A. Baum, Kristen E Pascal, Jasmin Quandt, D. Maurus, Sebastian Brachtendorf, Verena Lörks, Julian Sikorski, R. Hilker, D. Becker, Ann-Kathrin Eller, J. Grützner, Carsten Boesler, Corinna Rosenbaum, Marie-Cristine Kühnle, U. Luxemburger, Alexandra Kemmer-Brück, D. Langer, Martin Bexon, S. Bolte, K. Karikó, T. Palanché, Boris Fischer, A. Schultz, P. Shi, C. Fontes-Garfias, John L. Perez, K. Swanson, Jakob Loschko, I. Scully, M. Cutler, W. Kalina, C. Kyratsous, D. Cooper, P. Dormitzer, K. Jansen, Ö. Türeci
Nature, 2020
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.
Cited by 353 publications.
Field of study: Medicine