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).
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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, EU-COVAT-1 AGED study group on behalf of the VACCELERATE consortium
Аннотация
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.