%0 Journal Article
%T 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).
%A Stemler J
%A Yeghiazaryan L
%A Stephan C
%A Mohn KG
%A Carcas-Sansuan AJ
%A Rodriguez ER
%A Moltó J
%A Mitxeltorena IV
%A Welte T
%A Zablockienė B
%A Akova M
%A Bethe U
%A Heringer S
%A Salmanton-García J
%A Jeck J
%A Tischmann L
%A Zarrouk M
%A Cüppers A
%A Biehl LM
%A Grothe J
%A Mellinghoff SC
%A Nacov JA
%A Neuhann JM
%A Sprute R
%A Frías-Iniesta J
%A Negi R
%A Gaillard C
%A Saini G
%A León AG
%A Mallon PWG
%A Lammens C
%A Hotterbeekx A
%A Loens K
%A Malhotra-Kumar S
%A Goossens H
%A Kumar-Singh S
%A König F
%A Posch M
%A Koehler P
%A Cornely OA
%A  
%J Int J Infect Dis
%V 146
%N 0
%D 2024 Sep 9
%M 38992789
%F 12.074
%R 10.1016/j.ijid.2024.107161
%X <B>OBJECTIVE: </B>To assess the safety and immunogenicity of a fourth vaccination (second booster) in individuals aged ≥75 years.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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%).<BR><B>CONCLUSIONS: </B>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.