1. Reactogenicity, Safety, and Serological and Cellular Immunogenicity of a Booster Dose of SARS-CoV-2 mRNA Prototype, Variant, and Bivalent Vaccines
- Author
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Evan J. Anderson, Lisa A. Jackson, Nadine G. Rouphael, Alicia T. Widge, David Montefiori, Nicole A. Doria-Rose, Mehul Suthar, Kristen W. Cohen, Sarah O’Connell, Mat Makowski, Mamodikoe Makhene, Wendy Buchanan, Paul Spearman, C. Buddy Creech, Sijy O’Dell, Stephen D Schmidt, Brett Leav, Hamilton Bennett, Rolando Pajon, Christine M. Posavad, John Hural, John H. Beigel, Jim Albert, Kuleni Abebe, Amanda Eaton, Christina A. Rostad, Paulina A. Rebolledo, Satoshi Kamidani, Daniel S. Graciaa, Rhea Coler, Adrian McDermott, Julie E. Ledgerwood, John R. Mascola, Stephen C. De Rosa, Kathleen M. Neuzil, M. Juliana McElrath, and Paul C. Roberts
- Abstract
Waning immunity after two SARS-CoV-2 mRNA vaccinations and the emergence of variants precipitated the need for booster doses. We evaluated safety and serological and cellular immunogenicity through 6 months after a third mRNA vaccination in adults who received the mRNA-1273 primary series in the Phase 1 trial approximately 9 to 10 months earlier. The booster vaccine formulations included 100 mcg of mRNA-1273, 50 mcg of mRNA-1273.351 that encodes Beta variant spike protein, and bivalent vaccine of 25 mcg each of mRNA-1273 and mRNA-1273.351. A third dose of mRNA vaccine appeared safe with acceptable reactogenicity. Vaccination induced rapid increases in binding and neutralizing antibody titers to D614G, Beta, Delta and Omicron variants that persisted through 6 months post-boost, particularly after administration of Beta-containing vaccines. Spike-specific CD4 + and CD8 + T cells increased to levels similar to those following the second dose. Boost vaccination induced broad and durable humoral and T cell responses. ClinicalTrials.gov numbers NCT04283461 (mRNA-1273 Phase 1) and NCT04785144 (mRNA-1273.351 Phase 1)
- Published
- 2022
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