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Safety and immunogenicity of an mRNA-lipid nanoparticle vaccine candidate against SARS-CoV-2

2021; Springer Science+Business Media; Volume: 133; Issue: 17-18 Linguagem: Inglês

10.1007/s00508-021-01922-y

1613-7671

Peter G. Kremsner, Philipp Mann, Arne Kroidl, Isabel Leroux‐Roels, Christoph Schindler, Julian Gabor, Mirjam Schunk, Geert Leroux‐Roels, Jacobus J. Bosch, Rolf Fendel, Andrea Kreidenweiss, Thirumalaisamy P. Velavan, Mariola Fotin‐Mleczek, Stefan O. Mueller, Gianluca Quintini, Oliver Schönborn‐Kellenberger, Dominik Vahrenhorst, Thomas Verstraeten, Margarida Mesquita, Lisa Walz, Olaf‐Oliver Wolz, Lidia Oostvogels, Fien De Boever, Anniek Desimpel, Meral Esen, Itzhak Fischer, Judith Flügge, Otto Geisenberger, Christof Geldmacher, Katrin Held, Larissa Hoffmann, Michael Hölscher, Kristina Huber, Bart Jacobs, Jasper Joye, Jacqueline Kirschke, Norman Klopp, Erik Koehne, Carsten Köhler, Albert Lalremruata, Carlos Lamsfus Calle, Le Thi Kieu Linh, Cathy Maes, Dafni Metaxa, Marie-Luise Molnar, Mariana Mueller, Gesine Müller-Schöner, Marion Quindel, Sabine Rappe, Liz Schultze-Naumburg, Carsten Schumacher, Sabine Schuster, Verena Thiel, Susanne Vejda, Gwenn Waerlop, Carola Westenberg, Katrin Wons, Andreas Zeder,

Immunotherapy and Immune Responses

We used the RNActive® technology platform (CureVac N.V., Tübingen, Germany) to prepare CVnCoV, a COVID-19 vaccine containing sequence-optimized mRNA coding for a stabilized form of SARS-CoV‑2 spike (S) protein encapsulated in lipid nanoparticles (LNP).This is an interim analysis of a dosage escalation phase 1 study in healthy 18-60-year-old volunteers in Hannover, Munich and Tübingen, Germany, and Ghent, Belgium. After giving 2 intramuscular doses of CVnCoV or placebo 28 days apart we assessed solicited local and systemic adverse events (AE) for 7 days and unsolicited AEs for 28 days after each vaccination. Immunogenicity was measured as enzyme-linked immunosorbent assay (ELISA) IgG antibodies to SARS-CoV‑2 S‑protein and receptor binding domain (RBD), and SARS-CoV‑2 neutralizing titers (MN50).In 245 volunteers who received 2 CVnCoV vaccinations (2 μg, n = 47, 4 μg, n = 48, 6 μg, n = 46, 8 μg, n = 44, 12 μg, n = 28) or placebo (n = 32) there were no vaccine-related serious AEs. Dosage-dependent increases in frequency and severity of solicited systemic AEs, and to a lesser extent local AEs, were mainly mild or moderate and transient in duration. Dosage-dependent increases in IgG antibodies to S‑protein and RBD and MN50 were evident in all groups 2 weeks after the second dose when 100% (23/23) seroconverted to S‑protein or RBD, and 83% (19/23) seroconverted for MN50 in the 12 μg group. Responses to 12 μg were comparable to those observed in convalescent sera from known COVID-19 patients.In this study 2 CVnCoV doses were safe, with acceptable reactogenicity and 12 μg dosages elicited levels of immune responses that overlapped those observed in convalescent sera.