Stemler, Jannik 
ORCID: 0000-0001-9152-2469, Yeghiazaryan, Lusine, Stephan, Christoph ORCID: 0000-0003-3777-9006, Mohn, Kristin Greve-Isdahl, Carcas-Sansuan, Antonio-José ORCID: 0000-0003-1823-4174, Rodriguez, Esperanza Romero, Moltó, José, Mitxeltorena, Itziar Vergara, Welte, Tobias, Zablockienė, Birutė ORCID: 0000-0001-8519-6265, Akova, Murat, Bethe, Ullrich ORCID: 0000-0001-9979-1671, Heringer, Sarah, Salmanton-García, Jon ORCID: 0000-0002-6766-8297, Jeck, Julia ORCID: 0000-0002-4669-690X, Tischmann, Lea ORCID: 0000-0003-0178-0670, Zarrouk, Marouan ORCID: 0000-0002-3259-6123, Cüppers, Arnd ORCID: 0000-0001-8971-9481, Biehl, Lena M. ORCID: 0000-0001-7613-8119, Grothe, Jan ORCID: 0000-0001-8498-231X, Mellinghoff, Sibylle C. ORCID: 0000-0003-3928-2503, Nacov, Julia A. ORCID: 0000-0002-5327-2937, Neuhann, Julia M. ORCID: 0000-0003-4479-6322, Sprute, Rosanne ORCID: 0000-0003-2457-6437, Frías-Iniesta, Jesús, Negi, Riya, Gaillard, Colette, Saini, Gurvin, León, Alejandro García, Mallon, Patrick W.G., Lammens, Christine, Hotterbeekx, An, Loens, Katherine ORCID: 0009-0008-3009-2862, Malhotra-Kumar, Surbhi, Goossens, Herman, Kumar-Singh, Samir, König, Franz, Posch, Martin, Koehler, Philipp ORCID: 0000-0002-7386-7495 and Cornely, Oliver A. ORCID: 0000-0001-9599-3137
(2024).
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).
International Journal of Infectious Diseases, 146.
pp. 1-11.
Elsevier.
ISSN 1201-9712
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Abstract
[Artikel-Nr.: 107161] 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.
| Item Type: | Article |
| Creators: | Creators Email ORCID ORCID Put Code Yeghiazaryan, Lusine UNSPECIFIED UNSPECIFIED UNSPECIFIED Mohn, Kristin Greve-Isdahl UNSPECIFIED UNSPECIFIED UNSPECIFIED Rodriguez, Esperanza Romero UNSPECIFIED UNSPECIFIED UNSPECIFIED Moltó, José UNSPECIFIED UNSPECIFIED UNSPECIFIED Mitxeltorena, Itziar Vergara UNSPECIFIED UNSPECIFIED UNSPECIFIED Welte, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Akova, Murat UNSPECIFIED UNSPECIFIED UNSPECIFIED Heringer, Sarah UNSPECIFIED UNSPECIFIED UNSPECIFIED Frías-Iniesta, Jesús UNSPECIFIED UNSPECIFIED UNSPECIFIED Negi, Riya UNSPECIFIED UNSPECIFIED UNSPECIFIED Gaillard, Colette UNSPECIFIED UNSPECIFIED UNSPECIFIED Saini, Gurvin UNSPECIFIED UNSPECIFIED UNSPECIFIED León, Alejandro García UNSPECIFIED UNSPECIFIED UNSPECIFIED Mallon, Patrick W.G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lammens, Christine UNSPECIFIED UNSPECIFIED UNSPECIFIED Hotterbeekx, An UNSPECIFIED UNSPECIFIED UNSPECIFIED Malhotra-Kumar, Surbhi UNSPECIFIED UNSPECIFIED UNSPECIFIED Goossens, Herman UNSPECIFIED UNSPECIFIED UNSPECIFIED Kumar-Singh, Samir UNSPECIFIED UNSPECIFIED UNSPECIFIED König, Franz UNSPECIFIED UNSPECIFIED UNSPECIFIED Posch, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED |
| URN: | urn:nbn:de:hbz:38-814261 |
| Identification Number: | 10.1016/j.ijid.2024.107161 |
| Journal or Publication Title: | International Journal of Infectious Diseases |
| Volume: | 146 |
| Page Range: | pp. 1-11 |
| Number of Pages: | 11 |
| Date: | September 2024 |
| Publisher: | Elsevier |
| ISSN: | 1201-9712 |
| Language: | English |
| Faculty: | Faculty of Medicine |
| Divisions: | CECAD - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases Faculty of Medicine > Innere Medizin > Klinik I für Innere Medizin - Hämatologie und Onkologie Faculty of Medicine > Weitere > Centrum für integrierte Onkologie (CIO) Faculty of Medicine > Weitere > Zentrum für Klinische Studien |
| Subjects: | Medical sciences Medicine |
| Uncontrolled Keywords: | Keywords Language SARS-CoV-2 ; Advanced age ; Booster vaccination ; Immunosenescence ; Variants of concern ; Neutralizing antibodies English |
| ['eprint_fieldname_oa_funders' not defined]: | Publikationsfonds UzK |
| Refereed: | Yes |
| URI: | http://kups.ub.uni-koeln.de/id/eprint/81426 |
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