Authors
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 WG Mallon, Christine Lammens, An Hotterbeekx, Katherine Loens, Surbhi Malhotra-Kumar, Herman Goossens, Samir Kumar-Singh, Franz König, Martin Posch, Philipp Koehler, Oliver A Cornely
Publication date
2024/9/1
Journal
International Journal of Infectious Diseases
Volume
146
Pages
107161
Publisher
Elsevier
Description
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 …