Immunogenicity, reactogenicity, and safety of a second booster with BNT162b2 or full-dose mRNA-1273: A randomized VACCELERATE trial in adults aged ≥75 years (EU-COVAT-1-AGED Part B)

Autor: Jannik Stemler, Lusine Yeghiazaryan, Christoph Stephan, Kristin Greve-Isdahl Mohn, Antonio-José Carcas-Sansuan, Esperanza Romero Rodriguez, José Moltó, Itziar Vergara Mitxeltorena, Tobias Welte, Birutė Zablockienė, Murat Akova, Ullrich Bethe, Sarah Heringer, Jon Salmanton-García, Julia Jeck, Lea Tischmann, Marouan Zarrouk, Arnd Cüppers, Lena M. Biehl, Jan Grothe, Sibylle C. Mellinghoff, Julia A. Nacov, Julia M. Neuhann, Rosanne Sprute, Jesús Frías-Iniesta, Riya Negi, Colette Gaillard, Gurvin Saini, Alejandro García León, Patrick W.G. Mallon, Christine Lammens, An Hotterbeekx, Katherine Loens, Surbhi Malhotra-Kumar, Herman Goossens, Samir Kumar-Singh, Franz König, Martin Posch, Philipp Koehler, Oliver A. Cornely
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: International Journal of Infectious Diseases, Vol 146, Iss , Pp 107161- (2024)
Druh dokumentu: article
ISSN: 1201-9712
DOI: 10.1016/j.ijid.2024.107161
Popis: 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.
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