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Войти в исследования Immunogenicity, reactogenicity, and safety to assess booster vaccinations with BNT162b2 or double-dose mRNA-1273 in adults ≥75 years (EU-COVAT-1-AGED)-final report.
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Stemler Jannik, Yeghiazaryan Lusine, Stephan Christoph, Greve-Isdahl Mohn Kristin, Cox Rebecca Jane, Carcas-Sansuan Antonio Javier, Romero Rodriguez Esperanza, Moltó José, Vergara Mitxeltorena Itziar, Pink Isabelle, Welte Tobias, Zablockienė Birutė, Akova Murat, Bethe Ullrich, Grimm Sarah, Salmanton-García Jon, Jakobs 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 receive either BNT162b2 30 µg or a double booster dose of mRNA-1273, i.e., 100 µg, as the third and fourth vaccinations (first and second booster). The primary endpoint was the rate of a two-fold geometric mean titer (GMT) antibody increase 14 days after vaccination targeting the receptor binding domain (RBD) region of wild-type SARS-CoV-2. Secondary endpoints included neutralizing capacity against wild-type and 25 variants at 14 days (D14) and 12 months (M12). Safety was assessed by monitoring adverse events (AEs) for 7 days after vaccination.
FINDINGS: Between November 2021 and September 2022, 322 participants received a SARS-CoV-2 vaccine as a first (Part A) or second booster (Part B). Primary endpoint results have been published previously. In Part A, it was reached by 100% of participants in both vaccine arms, with a higher GMT increase in the mRNA-1273 arm (ratio, 1.64). At M12, the GMT of anti-RBD immunoglobulin G (IgG) was slightly higher than at D14 (9319.7 vs 8568.4 IU/mL) in the BNT162b2 arm, while in the mRNA-1273 arm, the GMT was equal (14,163.8 vs 14,266.7 IU/mL at D14). In Part B, the primary endpoint was reached by 78.5% of participants in the BNT162b2 and 87.2% in the mRNA-1273 arm (P = 0.056), respectively, with a higher GMT increase of anti-RBD IgG for mRNA-1273 (ratio, 1.38). At M12, GMT of anti-RBD IgG was markedly lower than at D14 (9962 vs 15,248.2 IU/mL) in the BNT162b2 arm as well as in the mRNA-1273 arm (12,024.3 vs 21,325.6 IU/mL). Higher neutralizing capacity in individuals who received a booster with mRNA-1273 was detected against wild-type and 15 of 25 tested variants. Fewer participants in the mRNA-1273 arm had vaccine-related AEs (29.6% vs 38.5%), but severity was more frequently grade 2 (n = 38, 28.1% vs n = 22, 16.3%).
INTERPRETATION: Long-term serological immunogenicity and virus neutralization capacity in participants ≥75 years of age were numerically better with an mRNA-1273 100 µg booster, with a comparable safety profile.