| Authors |
Stemler, Jannik ; Yeghiazaryan, Lusine ; Stephan, Christoph ; Mohn, Kristin Greve-Isdahl ; Carcas-Sansuan, Antonio-José ; Rodriguez, Esperanza Romero ; Moltó, José ; Mitxeltorena, Itziar Vergara ; Welte, Tobias ; Zablockienė, Birutė ; Akova, Murat ; Bethe, Ullrich ; Heringer, Sarah ; Salmanton-García, Jon ; Jeck, Julia ; Tischmann, Lea ; Zarrouk, Marouan ; Cüppers, Arnd ; Biehl, Lena M ; Grothe, Jan ; Mellinghoff, Sibylle C ; Nacov, Julia A ; Neuhann, Julia M ; Sprute, Rosanne ; Frías-Iniesta, Jesús ; Negi, Riya ; Gaillard, Colette ; Saini, Gurvin ; León, Alejandro García ; Mallon, Patrick W.G ; Lammens, Christine ; Hotterbeekx, An ; Loens, Katherine ; Malhotra-Kumar, Surbhi ; Goossens, Herman ; Kumar-Singh, Samir ; König, Franz ; Posch, Martin ; Koehler, Philipp ; Cornely, Oliver A |
| Abstract [eng] |
Objectives: To assess the safety and immunogenicity of a fourth vaccination (second booster) in individuals aged ≥75 years. Methods: Participants were randomized to BNT162b2 (Comirnaty, 30 µg) or messenger RNA (mRNA)-1273 (Spikevax, 100 µg). The primary end point was the rate of two-fold antibody titer increase 14 days after vaccination, targeting the receptor binding domain (RBD) region of wild-type SARS-CoV-2. The secondary end points included changes in neutralizing activity against wild-type and 25 variants. Safety was assessed by monitoring solicited adverse events (AEs) for 7 days. Results: A total of 269 participants (mean age 81 years, mRNA-1273 n = 135/BNT162b2 n = 134) were included. Two-fold anti-RBD immunoglobulin (Ig) G titer increase was achieved by 101 of 129 (78%) and 116 of 133 (87%) subjects in the BNT162b2 and the mRNA-1273 group, respectively (P = 0.054). A second booster of mRNA-1273 provided higher anti-RBD IgG geometric mean titer: 21.326 IU/mL (95% confidence interval: 18.235-24.940) vs BNT162b2: 15.181 IU/mL (95% confidence interval: 13.172-17.497). A higher neutralizing activity was noted for the mRNA-1273 group. The most frequent AE was pain at the injection site (51% in mRNA-1273 and 48% in BNT162b2). Participants in the mRNA-1273 group had less vaccine-related AEs (30% vs 39%). Conclusions: A second booster of either BNT162b2 or mRNA-1273 provided substantial IgG increase. Full-dose mRNA-1273 provided higher IgG levels and neutralizing capacity against SARS-CoV-2, with similar safety profile for subjects of advanced age. |
